Five supplements that claim to speed up weight loss – and what the science says


When you google “weight loss” the challenge to sort fact from fiction begins. These five supplements claim to speed up weight loss, but let’s see what the evidence says.

1. Raspberry ketones

Raspberry ketones, sold as weight loss tablets, are chemicals found in red raspberries responsible for that distinct raspberry flavour and smell. You can also make raspberry ketones in a lab.

A study in obese rats found raspberry ketones reduced their total body fat content. In one study, 70 adults with obesity were put on a weight loss diet and exercise program, and randomised to take a supplement containing either raspberry ketones, or other supplements such as caffeine or garlic, or a placebo.

Only 45 participants completed the study. The 27 who took a supplement lost about 1.9 kilos, compared to 400 grams in the 18 in the placebo group. The drop-out rate was so high that these results need to be interpreted with a lot of caution.

A small pilot study of five adults found no effect on weight when the participants were told to maintain their current eating and exercise patterns and just took supplements of 200mg/day of raspberry ketones.

Concerns have been raised about potential toxic effects of raspberry ketones on the heart and for reproduction.

Verdict: Fiction! Leave the raspberry ketone supplements on the shelf. Spend your money on foods that contain them, including fresh berries, kiwifruit, peaches, grapes, apples and rhubarb.



2. Matcha green tea powder

Matcha is a green tea made from leaves of the Camellia sinensis, or tea plant, but it’s processed into a green powder and can be mixed into liquids or food. Before the leaves are harvested, the tea plant is put in the shade for a few weeks, which increases the content of theanine and caffeine.

No studies have tested the effect of matcha on weight loss. A review of six studies using green tea preparations for weight loss over 12 weeks found a difference based on country. In studies conducted outside of Japan, people consuming green tea did not lose more weight than controls. In the eight studies conducted within Japan, the mean weight loss ranged from 200 grams to 3.5 kilos in favour of green tea preparations.

Verdict: Fiction! There are currently no studies testing whether matcha tea accelerates weight loss.


Read more: Science or Snake Oil: do skinny teas boost weight loss?


Tea has a reputation for weight loss that’s probably not deserved. from http://www.shutterstock.com

3. Garcinia cambogia supplements

Garcinia Cambogia is a tropical fruit that contains a large amount of Hydroxycitric Acid (HCA), claimed to aid weight loss.

In animal studies, HCA interferes with usual production of fatty acids. If this was transferred to humans it could theoretically make it harder to metabolise fat and speed up weight loss. Research studies in humans show this is not the case.

While one 12-week trial in overweight women randomised them to a low kilojoule diet, with or without HCA and found the HCA group lost significantly more weight (3.7 compared to 2.4 kilos for placebo), two other trials found no difference in weight loss.

A 12-week trial in 135 men and women found no difference in weight loss between the HCA group (3.2 kilos) and the placebo group (4.1 kilos). A ten-week trial in 86 men and women who were overweight and randomised to take either Garcinia Cambogia extract or placebo, but were not also put on a weight-loss diet, found minimal weight loss of 650 grams versus 680 grams, with no difference between groups.

Verdict: Fiction! Garcinia cambogia does not accelerate weight loss.



4. Caffeine supplements

Caffeine is claimed to increase your metabolic rate and therefore speed up weight loss. Research studies in volunteers of a healthy weight found an increase in metabolic rate, but it depended on the dose. The more caffeine supplements consumed, the more the metabolic rate went up.

The lowest caffeine dose of 100mg, the amount in one instant coffee, increased the average metabolic rate by nine calories per hour, while the 400mg dose, which is roughly equivalent to the caffeine found in two to three cups of barista-made coffee, increased metabolic rate by about 34 calories per hour over three hours.

When adults with obesity were given caffeine supplements at a dose of 8mg per kilo of body weight, there was an increase in metabolic rate of about 16% for up to three hours.

In a study in which adults with obesity were asked to follow a weight-loss diet, then randomised to receive either 200mg caffeine supplements three times a day for 24 weeks or a placebo supplement, there was no difference in weight change between groups. For the first eight weeks, the group taking caffeine supplements experienced side-effects of insomnia, tremor and dizziness.

Verdict: Fiction! While caffeine does speed up the body’s metabolic rate in the short-term, it does not speed up weight loss.


 

5. Alkaline water

Alkalising products are promoted widely. These include alkaline water, alkalising powders and alkaline diets. You’re supposed to measure the acidity of your urine and/or saliva to “assess” body acidity level. Urine usually has a slightly acidic pH (average is about pH6) – vegetables and fruit make it more alkaline, while eating meat makes it less so.

Saliva has a neutral pH of 7. Alkaline diets recommend you modify what you eat based on your urine or saliva pH, claiming a more alkaline pH helps digestion, weight loss and well-being.

But your stomach is highly acidic at a pH less than 3.5, with this acid helping breakdown food. It then moves into the small bowel for digestion and absorption where the pH increases to 4.5-5.0, which is still acidic.

Your body has finely controlled pH balancing mechanisms to make sure your blood pH stays between 7.35-7.45. If it did not, you would die.

On the positive side, alkaline diets encourage healthier eating by promoting plant based foods such as fruit and vegetables. There is some evidence lower intakes of foods of animal origin that contribute to acid load are associated with better long-term health.

Verdict: Fiction! There is no scientific evidence to support alkaline water or powders speeding up weight loss.

High levels of CoQ10 can lower your chances of dementia by 77%


Image: High levels of CoQ10 can lower your chances of dementia by 77%

Dementia, despite its prevalence, remains largely a mystery to doctors and scientists, who have yet to find a foolproof way to prevent or treat the illness. We’ve all heard that foods like blueberries and those containing omega 3s can reduce your risk to a degree, but one of the more exciting developments in the fight against dementia in recent years is the ability of coenzyme Q10, or coQ10, to significantly lower your risk.

A study that was published in the Atherosclerosis journal highlighted this ability after looking at adults aged between 40 and 69. They compared those who developed dementia with control subjects who were the same age but did not develop the disease, measuring the serum CoQ10 levels of everyone involved.

They discovered that those individuals whose levels of CoQ10 were within the top 25 percent of all those measured enjoyed a remarkable 77 percent lower chance of developing dementia than those who fell into the lowest quarter of CoQ10 levels. In addition, those with the highest levels of CoQ10 also had healthier levels of cholesterol.

Why is CoQ10 so useful in this regard? According to experts, it lowers oxidative stress in the brain, along with amyloid plaque. It also helps to heal the mitochondrial impairment that stands in the way of energy production.

Could you use more CoQ10?

Your body naturally produces the antioxidant CoQ10, which is also known as ubiquinone. Its main job is helping your body convert the food you eat into the energy needed to power your brain and your body in general, but it also serves other purposes, such as preventing blood clots.

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As you age, your CoQ10 levels will decrease naturally, and they also drop very low if you have heart disease, dementia, Parkinson’s, HIV/AIDS, or cancer. Deficiencies can also be seen in those who take statins. Unfortunately, having low levels of CoQ10 has been linked to a host of illnesses like cancer progression and melanoma metastasis.

Because nearly every cell in your body depends on CoQ10, it’s important to ensure you are getting enough of it – especially if you are hoping to reduce your chances of developing dementia later in life, along with other brain diseases like Parkinson’s.

You can find CoQ10 in oily fish like salmon, sardines, mackerel and tuna, which also have the benefit of containing lots of healthy fats. It can also be found in soybeans, peanuts, spinach, cauliflower, and broccoli.

It’s difficult to get enough CoQ10 from your diet, so many people enlist the help of supplements to ensure their levels are adequate. In fact, CoQ10 supplements have proven useful in lowering cancer risk and helping to heal heart disease. The supplements can also help those suffering from high blood sugar and even diabetes.

Because it’s made naturally by your body, it is considered generally quite safe to take as a supplement, as long as you are getting a pure product from a trustworthy source. Studies haven’t found any serious side effects, although some people may experience mild effects like nausea, heartburn, headaches or insomnia. Some people might want to steer clear, however, such as those who are pregnant or taking blood thinners, chemotherapy medications, or beta blockers.

Although we are still only scratching the surface when it comes to understanding this puzzling disease, it’s encouraging to know that there are safe and natural ways you can reduce the chances you’ll develop dementia.

Accumulating evidence suggests curcumin and turmeric can treat psychiatric disorders


Living with a psychiatric disorder can be devastating for both sufferers and their loved ones. Unfortunately, many of the solutions offered by modern medicine do more harm than good while offering little in the way of relief. Thankfully, researchers have discovered that a compound in the popular Indian spice turmeric has the potential to effectively treat psychiatric disorders like bipolar disorder and depression.

You may have heard the fanfare about turmeric’s anti-inflammatory properties, which it gets from a compound within the spice known as curcumin. It has long been used in traditional Chinese medicine and has been gaining popularity in Western medicine in recent years. This polyphenol is being revered for its protective, anti-inflammatory and antioxidant properties, and is being used to help fight cancer and stop the cognitive decline of neurodegenerative disorders like Alzheimer’s. Non-toxic and affordable, it’s showing a lot of promise in helping deal with many of the health problems facing people today.

Image: Accumulating evidence suggests curcumin and turmeric can treat psychiatric disorders

The same anti-inflammatory qualities that make it so good at addressing issues like arthritis can also extend to mood disorders. Not only does it reduce levels of tumor necrosis factor alpha and inflammatory interleukin-1 beta, but it also reduces salivary cortisol concentrations while raising the levels of plasma brain-derived neurotrophic factor.

A study carried out by researchers at Australia’s Murdoch University found that curcumin extracts reduced people’s anxiety and depression scores. They noted that it was particularly effective at alleviating anxiety. Moreover, even low doses of the spice extract were effective in addressing depression. In addition, the researchers found it worked quite well on those with atypical depression, which is a marker of bipolar depression.

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Growing evidence of curcumin’s usefulness in addressing psychiatric disorders

Curcumin has been found in other studies to be just as effective as one of the most popular SSRI antidepressants on the market, Prozac, making it an excellent option for those who wish to avoid the negative side effects of this psychiatric medication. It works by raising levels of dopamine and serotonin, two vital neurotransmitters related to depression. In addition, because depression is believed to be caused by chronic inflammation, it makes sense that curcumin’s ability to reduce inflammation could alleviate depression.

Interestingly, studies have also found that when curcumin is taken either alone or with saffron, it reduces the symptoms of anxiety and depression in those suffering from major depressive disorder. When taken alongside the herb fenugreek, meanwhile, it can reduce fatigue, stress and anxiety in those with extreme occupational stress. Curcumin supplementation has also been shown to significantly improve compulsiveness and memory loss in those with obsessive-compulsive disorder.

It’s also worth noting that curcumin can be taken alongside antidepressants safely; studies have even shown taking the two together can enhance their effectiveness. However, it’s important to keep in mind that antidepressants carry a lot of risks, so it’s worth exploring whether curcumin alone could be enough to alleviate an individual’s depression.

The idea of curcumin helping with mood is supported by a study that was published in the American Journal of Geriatric Psychiatry earlier this year. In that study, researchers found that participants who took curcumin supplements noted mood improvements, and they plan to explore this connection in a study of patients with depression. The researchers expressed optimism that curcumin could be a safe way to provide people with cognitive benefits; they also discovered the spice can improve memory.

Now, researchers are looking for ways to increase curcumin’s bioavailability so that people can enjoy the benefits of this all-star natural treatment. In the meantime, be sure to add black pepper to your dishes when cooking with turmeric or look for curcumin supplements that contain piperine, a black pepper extract, as this boosts its bioavailability.

Study: Children with IBS found to be deficient in vitamin D


Image: Study: Children with IBS found to be deficient in vitamin D

As many as one in six children suffer from irritable bowel syndrome (IBS) and its uncomfortable symptoms, including cramps, bloating, diarrhea and constipation. However, it appears that many children with IBS are also deficient in vitamin D.

A study published in PLOS ONE revealed that more than 90 percent of children with IBS lack vitamin D.

Being deficient in vitamin D likewise increases their risk for decreased bone mass, as having adequate vitamin D levels is important for the growth and development of bones of children.

In the study, the researchers analyzed the medical records of 55 children with IBS and compared their data to 116 healthy controls. The results revealed that one out of every two children with IBS is deficient in vitamin D compared to one out of every four healthy children and adolescents without IBS.

The study further looked into the association between vitamin D status and the presence of anxiety, depression, and migraine headaches that often come with IBS. Patients with IBS and migraine had significantly lower vitamin D levels compared to controls, which suggests that supplementing with Vitamin D might improve their headache symptoms.

With these findings, the researchers recommend pediatric IBS patients to monitor their vitamin D status and supplement with vitamin D if they are deficient in the vitamin.

More on vitamin D

Vitamin D helps the body absorb calcium, which is one of the building blocks of bone. Vitamin D also plays a role in the nervous, muscle, and immune systems. There are three ways to get vitamin D: through the skin, from food, and from supplements. Foods that are naturally rich in vitamin D include fatty fish like salmon and tuna, beef liver, raw cheese, mushrooms, and egg yolks. After being exposed to sunlight, the body naturally produces vitamin D. However, too much exposure to the sun can result in skin aging and skin cancer, which is why many people try to get their vitamin D from other sources.

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The amount of vitamin D a person needs every day depends on their age. The recommended amounts of vitamin D are the following:

  • Birth to 12 months: 400 international units (IU)
  • Children 1 to 13 years: 600 IU
  • Teens 14 to 18 years: 600 IU
  • Adults 19 to 70 years: 600 IU
  • Adults 71 years and older: 800 IU
  • Pregnant and breastfeeding women: 600 IU

Unfortunately, many are deficient in vitamin D. In the U.S. alone, approximately 42 percent of the population is vitamin D deficient. People can become deficient in vitamin D for various reasons. Some may not get enough vitamin D in their diet or have a malabsorption problem, in which they could not absorb enough vitamin D from food, while others may not get enough sunlight exposure. Some people may also have problems with their liver or kidneys that these organs cannot convert vitamin D to its active form in the body. Taking certain medicines can also interrupt the body’s ability to covert or absorb vitamin D. (Related: Vitamin D deficiency is widespread among U.S. population, expectant mothers are deficient and giving birth to deficient infants.)

As mentioned earlier, vitamin D is important for bone growth and development. Severe vitamin D deficiency can result in bone density loss, which can contribute to osteoporosis and fractures. Vitamin D deficiency can also result in many other diseases. In children, it can cause rickets, which is a rare condition that causes the bones to become soft and bend. In adults, it can result in osteomalacia, which causes weak bones, bone pain, and muscle weakness.

Read more news stories and studies on the importance of vitamin D by going to VitaminD.news.

Sources include:

UMassMed.edu

MedlinePlus.gov

CantonMercy.org

Groundbreaking study reveals that heart disease is an early indicator of vitamin C deficiency


Image: Groundbreaking study reveals that heart disease is an early indicator of vitamin C deficiency

Heart disease is usually linked to issues with cholesterol, but researchers are increasingly finding that vitamin C plays an outsized role in heart health. This antioxidant nutrient, which the body uses to make connective tissue, has already gotten some buzz for its utility in cancer treatment, but its effects on the heart may be even greater.

Researchers at the Dr. Rath Research Institute of California found that a vitamin C deficiency can cause coronary heart disease. In their study, they used transgenic mice that mimic the human metabolism in two key ways: They don’t produce vitamin C internally, and they generate lipoprotein to make up for this. After feeding the mice a diet that was lacking in vitamin C, their bodies acted as expected and created their own lipoprotein to fix the vascular walls. This caused them to develop heart issues and atherosclerosis.

Crucially, they discovered that the degree and level of heart disease the mice developed was directly linked to their vitamin C intake and blood levels. Those mice who had consumed the highest amounts of vitamin C naturally produced the least lipoprotein to repair their arteries, and by extension, had the strongest hearts and fewest atherosclerotic lesions.

Therefore, the researchers believe that proper vitamin C intake could be the secret to preventing heart disease and other cardiovascular problems. That doesn’t mean that cholesterol isn’t important; maintaining healthy HDL and LDL cholesterol levels is still a powerful component of overall health, but it may not play as big of a role as once believed.

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Higher vitamin C intake linked to lower heart disease risk

This is supported by a study that was recently published in the Journal of the American College of Nutrition. That study looked at 108 men and divided them into three groups according to their intake of vitamin C.

They found that the men in the top tier of vitamin C intake had a 66 percent lower risk of heart disease compared to those who had the lowest intake. The researchers aren’t sure exactly how vitamin C brings about such significant benefits to heart health. They theorize that it could be related to its ability to prevent and ease the stiffening in artery walls that can block the flow of blood. In fact, they discovered that the vitamin is especially effective at doing this in people who smoke.

Further studies provide additional evidence of vitamin C’s heart benefits. For example, a study carried out by the University of Copenhagen that involved more than 100,000 people found that higher blood concentrations of vitamin C were associated with a lower risk of not only cardiovascular disease but also death. It is important to keep in mind, however, that they saw this benefit in those whose high vitamin C blood levels came from eating lots of vegetables and fruits.

Getting vitamin C from food is preferable

The researchers said that although vitamin C supplements can help raise your levels of this important nutrient, getting it from a healthy diet is far preferable. Doing so will also help you develop a long-term healthy lifestyle, which will bring many other health benefits over time.

With heart disease being the leading cause of death around the world, we are lucky to have such an affordable way to prevent it that has very few side effects. Some of the best food sources of vitamin C include citrus fruits, acerola cherries, kale, broccoli, kiwis, strawberries, sweet potatoes, and bell peppers. Best of all, eating these foods will not just enhance your heart health; your immunity will also get a nice boost!

Sources for this article include:

NaturalHealth365.com

NaturalNews.com

USPSTF: Exercise, Not Supplements, for Preventing Falls


Updated recommendations from the US Preventive Services Task Force (USPSTF) continue to support exercise and multifactorial interventions to prevent falls in community-dwelling adults aged 65 years or older, but advise against vitamin D supplementation, according to two statements published online today in JAMA.

“The USPSTF recommendation, with increased emphasis on exercise, warrants adoption and should prove helpful, especially because exercise interventions reduce injurious falls,” write Heike A. Bischoff-Ferrari, MD, DrPH, from the University of Zurich, Switzerland, and colleagues in an accompanying editorial. The editorialists add that increasing physical activity reduces risks for other chronic diseases of aging.

Fall Prevention

Falls are the leading cause of injury-related morbidity and mortality among adults aged 65 years or older in the United States, affecting 29 million people in 2014 alone (28.7% of community-dwelling older adults) with 37.5% requiring medical treatment or restricting activities for a day or longer, according to the recommendation statement. Falls caused approximately 33,000 deaths in 2015.

The new guidelines continue the B recommendation for exercise interventions, which means clinicians should offer or provide the intervention and that there is high certainty that the net benefit is moderate, or moderate certainty that the net benefit is moderate to substantial.

The task force provides a C recommendation for selective offering of multifactorial interventions, which suggests there is limited benefit for some patients.

In contrast, USPSTF now recommends against vitamin D supplementation to prevent falls, with a D recommendation. The D recommendation means the task force discourages use because of moderate or high certainty of no net benefit or that harms outweigh benefits, which is a shift from the previous 2012 recommendation, when supplementation had a B grade.

That downgrade may be in part because USPSTF did not consider individuals taking vitamin D for deficiency for the current recommendation, but did include them in 2012.

An accompanying evidence report reviewed 62 randomized clinical trials involving 35,058 individuals to assess the effects of 7 types of interventions, focusing on three: 26 trials of multifactorial strategies, 21 trials of exercise, and 7 trials of vitamin D supplementation. Multifactorial and exercise interventions were associated with benefits and minimal harms, but vitamin D supplementation had “mixed results,” with one trial indicating an increase in falls, number of people falling, and injuries.

Alex H. Krist, MD, MPH, a family physician at Virginia Commonwealth University in Richmond, coauthor and vice chair of the USPSTF, is a big proponent of exercise interventions, but also embraces multifactorial approaches. “Multifactorial interventions start with assessing an individuals’ risk of falling and what’s contributing to why they might be falling. Then a tailored intervention might include physical therapy, exercise, nutrition therapy, medication management, changing the home environment, and social or community services,” he explained in a journal podcast.

Vitamin D, Calcium, and Combined Supplementation

The task force now concludes there is insufficient evidence to assess the balance of benefits and harms for vitamin D and calcium supplementation, alone or combined, to prevent fractures in asymptomatic men and premenopausal women (grade I).

Similarly, the task force says there is insufficient evidence to assess the balance of benefits and harms for supplement use by postmenopausal women for doses exceeding 400 IU of vitamin D and 1000 mg of calcium (grade I), and recommends against daily supplementation with 400 IU or less of vitamin D and 1000 mg or less of calcium in this patient population (grade D).

The task force, however, did find sufficient evidence confirming an increased risk for kidney stones with combined vitamin D and calcium supplementation, and indicating no increased incidence of cardiovascular disease with vitamin D supplementation.

The evidence report for supplementation evaluated 11 randomized controlled trials of 51,419 adults older than 50 years and not institutionalized or known to have vitamin D deficiency, osteoporosis, or prior fractures.

David B. Reuben, MD, from the David Geffen School of Medicine, points out in an editorial published in JAMA Internal Medicine that the recommendations are for patient actions that are ongoing, not a one-time intervention. Parsing data, however, may reveal benefits, he suggests, referring to the Women’s Health Initiative, in which hip fracture decreased 29% among women who took at least 80% of the supplement tablets. He suggests that “perhaps the Task Force’s recommendation should be for calcium or vitamin D supplementation that includes an intervention to promote high levels of adherence.”

Dr Bischoff-Ferrari and colleagues note in their editorial that “the complementary articles reinforce the importance of fall prevention in reducing the risk of fractures (and other injuries) among older adults.”

Added Dr Krist in the podcast, “We felt these topics were very similar. We decided we’d bundle the topics to make it easier to understand the evidence.”

How Much Protein Do You Really Need?


It’s important food for your cells, but is it possible to overdo it?
Protein-You-Really-Need_Feature

With so many protein bars, shakes, and supplements on the market, it’s kind of been hammered into our heads that protein is the wonder nutrient.

It is an important building block for our cells, essential to repair old ones and build new ones. Which is why we think about it most commonly as a post-workout muscle-builder. Recent compelling studies have shown that a higher-protein diet may potentially help with weight management—particularly by helping us feel more satiated, and helping burn fat mass and maintain lean muscle. It also may have benefits for your heart. But the research is small and far from conclusive.

So how much protein should you eat? And can you ever eat too much? We talked to nutritionists and scoured studies to find out how much protein is healthy to pack into each day.

First of all, there’s no easy one-size-fits-all recommendation on how much protein you should get.

The current USDA Dietary Guidelines recommend protein make up somewhere between 10 and 35 percent of your daily calories (but some nutrition experts think 35 sounds really high). A lot of people automatically think of 2,000 calories a day as the standard, but that might not be right for you—you may be eating more or less depending on your weight, fitness level, weight loss goals, and if you’re pregnant.

“Your [ideal amount of protein] will vary based on caloric needs and whatever else you have going on,” Kristen F. Gradney, R.D., director of nutrition and metabolic services at Our Lady of the Lake Regional Medical Center and spokesperson for the Academy of Nutrition and Dietetics, tells SELF. “For example, if you work out and lift weights three or four days a week, you’re going to need a little more than somebody who doesn’t. It varies.”

You can also use the calculation from the Institute of Medicine, which says the Recommended Daily Allowance (RDA) of protein for adults should be 0.8 g/kg body weight. To calculate it, divide your weight in pounds by 2.2, then multiply by 0.8. “So for a 130-pound woman, that would be 47 grams of protein,” explains Jessica Fishman Levinson, R.D., founder of nutrition counseling company Nutritioulicious. For an even more personalized look at your protein needs, use this handy USDA nutrient calculator, which also takes into account your height and activity level.

Let’s be honest: all of the different calculations make it a bit confusing. But in the end, you’ll get a very similar result no matter which way you think about it. Just remember that your recommended grams means grams of protein in your food, not the serving size. So for example, a 4-ounce piece of sirloin steak has 24 grams of protein.

Complicated math aside, chances are you’re getting the right amount of protein without even thinking about it.

According to the 2015 USDA dietary guidelines committee, most people are getting just about (or just under) the recommended amount of “protein foods,” meaning meat, poultry, and eggs. Here’s the rub: “protein foods” doesn’t include dairy, soy, or grains, so if you’re eating those things (which you probably are), it’s likely you’re right in the middle of the recommendations without really trying.

Research published in the American Journal of Clinical Nutrition following a protein summit of over 60 nutrition experts found that the average American currently gets 16 percent of their daily calories from protein, but that we could eat more than that. The suggestion to increase protein intake isn’t widely accepted though, and more research needs to be done to determine if the benefits are enough to make sweeping recommendations.

There is a chance of overdoing it, and over time that can lead to some adverse health effects.

“You can always have too much of anything,” Levinson says. “But [overloading on protein] is more common in athletes and body builders, especially those who use protein powders multiple times a day in addition to the other protein they’re getting from their diet,” Levinson explains.

Most nutrients have a certain level that the average person can eat in a day before experiencing negative effects, called the “tolerable upper intake level.” Right now, there isn’t one that’s known for protein because we don’t have enough research to show what it would be.

Eating too much protein over time (months or years, depending on genetics) can lead to kidney problems, though. “Protein is a very big molecule that your body has to break down,” Gradney explains, so overloading puts unnecessary pressure on the kidneys. If your protein sources are animal-based, eating too much can also mean eating too many saturated fats, which can affect your heart and weight negatively.

Other downfalls of eating too much protein: “If intake of protein is more than needed, it won’t be burned and instead will be stored in the body and can lead to weight gain,” Levinson says. Also, eating too much protein might make you eat less of other important nutrients, making your diet unbalanced. If you’re replacing carbs, which your body burns for fuel, your body may start to burn protein instead, which can lead to bad breath, she adds. It can also, weirdly, make your sweat smell like ammonia—it’s one of the by-products when the amino acids in protein are broken down.

In the end, the types of protein you eat (and when) matters the most.

In general, according to the 2015 Dietary Guidelines, we’re eating enough protein. However, Levinson says, we’re not necessarily getting it from the best sources. Many people (especially boys and men) are getting too much of it from meat, poultry and eggs, and not enough from seafood and legumes, which count as both a protein and a vegetable.

Eating a variety of proteins will also ensure you’re not missing out on the other nutrients your body needs, or going overboard on calories. And it’s pretty much impossible to overeat protein on a plant-based diet, so it’s more likely you’ll naturally stay within your ideal intake range versus if you’re only getting protein from red meat and poultry.

Spacing out your protein intake throughout the day may help enhance protein’s effects on your muscles. “Research is showing that protein should be spread out throughout the day rather than the majority being consumed at one meal, which is usually what people do when they eat most of their protein at dinner,” Levinson says. She suggests getting no more than 30 grams in one meal.

FDA: Massive Attack on Supplements


The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news.Highest-level Action Alert! We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency. What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately. Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.” Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product. In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc. The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:

  • the elimination of tens of thousands of supplements from the market;
  • an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA’s NDI notification protocols; and
  • the loss of between 55,270 and 104,475 jobs in the supplement industry.

ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL) stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements. ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since. We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented a disincentive for patented drug research.” This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America. News of this raid turned out to be the shot heard ’round the world for health freedom. Everybody got organized and started to fight back. By 1994, over two million letters went to Congress, which led to the passage of DSHEA. Congress for the first time began to have an inkling that diet mattered greatly for health and that dietary supplements could make a great deal of difference in our diet. When President Bill Clinton signed the bill into law, he stated that it represented “common sense.” The draft of regulations governing new dietary supplements under DSHEA, arriving twenty-two years after the passage of the legislation, and further delayed after the disastrous first draft in 2011, was finally published last Friday. It is a little better in some respects, but the biggest problems remain. It represents a dire threat to the supplement industry and, by extension, consumer access to supplements. First, the improvements. In the original guidance, the FDA had said that all dietary ingredients contained in supplements sold before 1994, but not marketed as a standalone dietary supplement, required a NDI notification. So if a green tea supplement marketed before 1994 also contained other natural dietary ingredients, the green tea would be grandfathered and not require a NDI, but the other ingredients would—an absurd stance that has been corrected in the new guidance. Now, dietary ingredients that were marketed as or were contained in dietary supplements before 1994 are grandfathered. The FDA’s new guidance also allows the submission of “NDI master files,” which contain specifications and other information needed to completely describe an ingredient. If a company wants to make several products with the same ingredient but at different dosages or concentrations, this could save a lot of time. These master files can also be shared with other companies to avoid excessive duplication. There is still no authoritative list of “grandfathered” ingredients that do not need to submit NDIs, but FDA has said in the new guidance that it is willing to develop such a list based on independent and verifiable data. This appears to be just another stalling tactic after twenty-two years of stalling. We can be sure that the agency will keep the list as short as possible. Unfortunately, that is the extent of the improvements in the new guidance versus the first draft. Most of the other problems that were in the original guidance remain in the updated draft. The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not of supplements. In addition the agency states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification. Are other drugs—even dangerous antipsychotics, antidepressants, and stimulants—subject to similar requirements when they are used on children? The answer is a resounding No. In the FDA’sown words, “Most drugs prescribed for children have not been tested in children.” The same is true for use with elderly people. The drugs have almost never been tested on elderly people. This makes the FDA’s new position on supplements especially hypocritical. The section on investigational new drugs (INDs) also remains. These provisions could destroy the future availability of many supplements. The jargon used here in the guidance is confusing, probably intentionally so, but bear with us. Remember that an IND refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient—that is, an ingredient is being studied for use as part of a new drug—that ingredient can no longer be produced or included in a supplement if a NDI has not previously been accepted. This has already happened to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug. Apparently the FDA couldn’t care less that this form of natural B6 is no longer available in any form. Indeed it has been considering a petition to ban the only remaining natural form of B6, the most important form of all, because all B6, synthetic or natural, must be converted to it in order for our bodies to use it. In this guidance, the FDA explicitly states that even when an IND is rescinded or does not lead to a new drug, the supplement form is still banned. Well, at least they admit what they are doing! But just imagine the mischief this could cause when some enterprising drug company decides to corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this guidance. Remember that it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs. The agency has also kept intact its ridiculous position that synthetic botanical ingredients are, for the most part, not dietary ingredients. This would likely remove many products from store shelves, such as vinpocetine, which is needed to keep our brains healthy. There is an exception for synthetic botanicals that are lawfully used as an ingredient in the conventional food supply, such as vanillin. What makes this even more confusing is that the FDA has already accepted NDI notifications for vinpocetine from a number of supplement producers. Note that in most cases, the FDA does not ever have to resolve the status of NDI notifications. The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement industry. It’s the same old story. The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well. Probiotics—the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on—could also be on the chopping block. The agency cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription—or costing $100 a bottle—will be a disaster for the health of Americans. This is pure nonsense. Why would the FDA do this? Clearly these are the actions of an agency looking to restrict the supplement market and remove as many products as possible in as many ways as possible—even thought it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements. Over the coming weeks we will continue to dissect the guidance and strategize about the best way to overturn this guidance in order to protect consumer access to dietary supplements. But right now, we need to send messages to the FDA but especially to Congress. We need to immediately register our opposition and dismay at what the FDA is, once again, trying to do in its relentless war against dietary supplements. By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.

Supplements Can Make You Sick


Dietary supplements are not regulated the same way as medications. This lack of oversight puts consumers’ health at risk.

Supplements are poorly regulated, putting consumers at risk.

Probiotics are powders, liquids, or pills made up of live bacteria thought to help maintain the body’s natural balance of gut microorganisms. Some neonatal intensive care units (NICUs) have been giving them to preemies in recent years based on evidence that they can help ward off deadly intestinal disease.

Some doctors are concerned about that trend. Because probiotics can be classified as dietary supplements, they don’t have to be held to the same regulatory standards as prescription or even over-the-counter drugs. Manufacturers don’t have to secure Food and Drug Administration approval to sell their products, and their facilities aren’t policed the same way as pharmaceutical companies.

But the NICU at Yale-New Haven chose what looked to be a safe product. It was made by a large, seemingly reputable company, marketed specifically for infants and children, and available at drugstores across the country.

Calvin struggled anyway. His abdomen developed bulges, and surgery revealed that his intestines were overrun by a rare fungus. The infection spread quickly from his gut to his blood vessels, where it caused multiple blockages, and then into his aorta, where it caused a clot.

On Oct. 11, at just 8 days old, baby Calvin died. Government officials then launched a mournful investigation. Where did the fungus come from? And how did it get into this premature baby’s tiny body?

Unproven Treatments

The answer is that the probiotic was contaminated. The FDA tested unopened containers from the same batch of probiotic given to Calvin and discovered the same fungus that had infected his intestines. Certain lots of the product—ABC Dophilus Powder, made by the supplement manufacturer Solgar—were recalled from pharmacies and drugstores across the U.S.

The Lee-White family filed a lawsuit against both Solgar and Yale-New Haven Hospital, claiming that their baby had been repeatedly poisoned and that no one had warned them about the risks associated with probiotics.

“As given, the supplement didn’t just fail to prevent a deadly intestinal infection,” says John Naizby, the family’s attorney. “The supplement actually caused a deadly intestinal infection.” Solgar told Consumer Reports via email that it conducted a thorough investigation in cooperation with the FDA and the Centers for Disease Control and Prevention (CDC) and found no contaminants at any point in its own supply chain. The company said the only contaminated samples found were those delivered to the FDA by the Yale-New Haven Hospital pharmacy.

The hospital declined to comment for this article. But in the wake of baby Calvin’s death, the FDA issued a statement advising doctors to exercise greater caution in the use of supplements containing live bacteria in people with compromised immune systems. Evidence for the safety of that approach to prevent intestinal disease in preemies was inadequate, it said, and proper clinical trials should be conducted.

The problem stretches well beyond one tainted probiotic. Dietary supplements—vitamins, minerals, herbs, botanicals, and a growing list of other “natural” substances—have migrated from the vitamin aisle into the mainstream medical establishment. Hospitals are not only including supplements in their formularies (their lists of approved medication), they’re also opening their own specialty supplement shops on-site and online. Some doctors are doing the same. According to a Gallup survey of 200 physicians, 94 percent now recommend vitamins or minerals to some of their patients; 45 percent have recommended herbal supplements as well. And 7 percent are not only recommending supplements but actually selling them in their offices.

Consumers are buying those products in droves. According to the Nutrition Business Journal, supplement sales have increased by 81 percent in the past decade. The uptick is easy to understand: Supplements are easier to get than prescription drugs, and they carry the aura of being more natural and thus safer. Theirlabels often promise to address health issues for which there are few easy solutions. Want a smaller waistline? There’s garcinia cambogia for that. Bigger muscles? Try creatine. Better sex? Yohimbe. How about giving your brain a boost? Omega-3 fatty acids. Or your energy level? Ginseng.

It’s tough to say what portion of those products pose a risk to consumers. A 2013 report from the Government Accountability Office (GAO) found that from 2008 through 2011, the FDA received 6,307 reports of health problems from dietary supplements, including 92 deaths, hundreds of life-threatening conditions, and more than 1,000 serious injuries or illnesses. The GAO suggests that due to underreporting, the real number of incidents may be far greater.

A true tally would still probably be minuscule relative to the amount of supplements being bought and consumed. But there’s no reliable way to tell whether any given supplement is safe. And the fact remains that dietary supplements—which your doctor may recommend and may sit right alongside trusted over-the-counter medications or just across from the prescription drug counter—aren’t being regulated the same way as drugs.

“Not only are the advertised ingredients of some supplements potentially dangerous,” says Pieter Cohen, M.D., an assistant professor of medicine at Harvard Medical School who has studied supplements extensively and written many papers on the issue, “but because of the way they’re regulated, you often have no idea what you’re actually ingesting.”

Consumers Are in the Dark

Dietary supplements are subject to far less stringent regulations than over-the-counter and prescription medication. The FDA classifies them differently from drugs. So the companies that make and sell them aren’t required to prove that they’re safe for their intended use before selling them, or that they work as advertised, or even that their packages contain what the labels say they do.

And because of those lax policies, supplements that make their way into retail stores, doctors’ offices, and hospitals can pose a number of potential problems. They can be ineffective, contaminated with microbes or heavy metals, dangerously mislabeled, or intentionally spiked with illegal or prescription drugs. They can also cause harmful side effects by themselves and interact with prescription medication in ways that make those drugs less effective.

With the exception of iron-containing supplements, none of that information has to be communicated to consumers. Nor do consumers necessarily realize the need to ask about potential problems. According to a 2015 nationally representative Consumer Reports survey, almost half of American adults think that supplement makers test their products for efficacy, and more than half believe that manufacturers prove their products are safe before selling them.

“You see these products in drugstores or in doctors’ offices, and you assume they’re as tried and true as any other medication being sold at those places,” says Paul Offit, M.D., an infectious disease specialist at the Children’s Hospital of Philadelphia, who has written a book about the supplement industry. “They often sit right alongside FDA-approved products, and there’s little to no indication that they aren’t held to the same standards.”

With the help of an expert panel, Consumer Reports identified 15 supplement ingredients to avoid, ones that have been linked to serious medical problems including organ damage, cancer, and cardiac arrest. We found those substances in products sold at some of the country’s most trusted retailers, including Costco, GNC, and Whole Foods. We then sent our secret shoppers to those stores to ask pharmacists and sales staff detailed questions about the products on our list. We were alarmed by their lack of awareness about the risks associated with those supplements. Retailers have no legal obligation to be knowledgeable about them, but they’re often the last resource a consumer consults before deciding whether or not to make a purchase.

 A Powerful Industry Is Born

Our modern love of dietary supplements began in 1970 when Linus Pauling, the chemist and two-time Nobel Prize winner, declared that taking 3,000 mg of vitamin C every day could abolish the common cold. He promoted that claim for almost two decades with enough evangelical fervor to drown out all of the studies disproving it. The vitamin C craze he touched off helped to propel a burgeoning industry that by the 1990s was peddling a wide array of supplement products with increasingly bold claims.

When the FDA stepped in to regulate, the industry fought back. Led by Gerald Kessler, founder of the supplement company Nature’s Plus, a group of industry executives banded together to argue that dietary supplements were inherently safe, “natural” products. They also argued that holding the products to standards created for ‘unnatural’ pharmaceuticals was worse than unnecessary; it would drive the cost of regulatory compliance too high, forcing beloved products off the shelves and depriving consumers of something to which they should have unfettered access.

Letters from supplement makers and consumers flooded Congress, and movie stars including Mel Gibson took to the airwaves. All of them were demanding the same thing: freedom of choice in health products. “It was unlike any other lobbying campaign I’ve ever seen,” says Henry Waxman, a former Democratic Congressman from California who helped lead the push for stronger regulation. “People believed what they were being told because it fed into their view that doctors, pharmaceutical companies, and the FDA wanted to block alternative medicines that could keep people healthy. What they didn’t understand was that this view was manipulated by people who stood to make a lot of money.”

 



 

Banking on Too Little Oversight

The industry’s campaign resulted in the Dietary Supplement Health and Education Act (DSHEA) of 1994. Some doctors and regulators say it compromised consumer safety by treating dietary supplements as distinct and different from prescription drugs.

Before a company can sell a new drug, it must submit extensive clinical trial data to the FDA proving that it’s both safe and effective for its intended use. Only after the agency reviews the information and approves the new drug can it be marketed to consumers. The process can take years and cost upward of $2 billion.

Under DSHEA, dietary supplements are held to a different standard. “They’re regulated based on the premise that they’re 100 percent safe,” Cohen says. Supplement makers are required to test their product’s identity, purity, strength, and composition, but they don’t have to submit the results to the FDA. They also have to notify the agency of new ingredients. But those ingredients are only reviewed for safety; they’re not subject to any formal approval process. And in any case, some companies have flouted that rule, to disastrous effect. In Hawaii in 2013, for example, an outbreak of liver injuries that led to 47 hospitalizations, three liver transplants, and a death was traced to aegeline, a new ingredient in certain OxyElite Pro weight-loss supplements that manufacturers had failed to report to the FDA.

Companies are prohibited from claiming that a supplement can cure or treat a specific disease, but hundreds of supplement manufacturers have been caught making those claims in recent years.

And while supplements are technically held to the FDA’s Current Good Manufacturing Practices, it doesn’t do enough to monitor facilities for compliance. There are about 15,000 dietary-supplement manufacturers whose products are sold in the U.S., according to a 2015 study in the journal Drug Testing and Analysis. Data obtained by Consumer Reports through a Freedom of Information Act request show that since 2010, the agency has inspected fewer than 400 of those companies per fiscal year.

Part of the problem is a lack of resources. Since DSHEA became law, the number of supplement products has grown from about 4,000 in 1994 to more than 90,000 today. The FDA’s budget to monitor supplements hasn’t grown in tandem. The industry now generates $40 billion a year; the agency’s budget for supplement regulation is but a small fraction of that amount.

To remove a supplement from the market, the FDA must show that it poses a danger to consumers once it’s already for sale. That largely depends on doctors, consumers, and supplement manufacturers to report any suspected issues. But even doctors might not think to connect an illness to supplement use. And if they do, they might not think to call the FDA. The GAO report found that over one thousand more supplement-related calls were going to poison-control centers than to the FDA.

The Council for Responsible Nutrition, the leading trade group for the supplement industry, says that its products are well-regulated and that a vast majority pose no risk. “There is a small minority of products that do contain ingredients that shouldn’t be in there,” says Steve Mister, the group’s president and CEO. “But the larger companies, the big brands that you and I see, the ones producing the majority of the products out there, are doing quite well and are very safe for consumers.”

Retail Russian Roulette

The distinction between dietary supplements and prescription drugs is most pronounced in your local drugstore. Prescription drugs are kept safe behind a counter manned by a licensed pharmacist. Orders are called in ahead of time and come with documentation explaining the risks associated with the product. Supplements come with no such safeguards. You can pluck them off a drugstore shelf without thinking twice. Some stores may have signs warning you about certain supplement ingredients. But if you have specific questions, you might be out of luck. Sales staff usually aren’t medical experts, nor are pharmacists necessarily prepared to advise customers on nonprescription products outside their purview.

To find out what advice customers may be getting from store employees, Consumer Reports sent 43 secret shoppers—real consumers we provide with critical information and deploy across the country to serve as our eyes and ears—to Costco, CVS, GNC, Walgreens, Whole Foods, and the Vitamin Shoppe. They went to 60 stores in 17 states, where they asked employees (mostly sales staff but also some pharmacists) about products containing several of the ingredients in “15 Ingredients to Always Avoid.”

Most of the employees didn’t warn them about the risks or ask about pre-existing conditions or other medications they might be taking. Many gave information that was either misleading or flat-out wrong.

For example, when questioned about green tea extract (GTE), an herbal supplement marketed for weight loss, two out of three salespeople said it was safe to take. None warned that the herb has been found to alter the effectiveness of a long list of drugs, including certain antidepressants and anticlotting drugs. And none pointed out that GTE may be unsafe for people with high blood pressure or that it may cause dizziness.

Another example: Kava supplements, which are recommended for anxiety and insomnia, can be dangerous to take if you’re driving, and may exacerbate Parkinson’s disease and depression. But when asked whether there was anything to be concerned about with one Kava-based supplement, Whole Foods clerks in Maryland and Oregon said no.

Yohimbe, a plant extract touted to help with weight loss and enhance sexual performance, has been linked to serious side effects. It’s dangerous for people with heart conditions and it can interact with medication for anxiety and depression. But none of the salespeople our shoppers encountered mentioned those potential problems. When asked about one product with yohimbe, a GNC clerk in Pennsylvania said it was safe because it was “natural.”

Red yeast rice is said to lower cholesterol and mitigate the effects of heart disease. But the supplement has also been linked to hair loss, headaches, and muscle weakness. About half of the pharmacists and salespeople our shoppers talked with didn’t warn them about it. Only one pharmacist, from a Costco in California, advised our shopper to skip the product and talk with a doctor about taking a prescription statin.

We reached out to the trade group for chain pharmacies as well as some of the individual stores our shoppers went to, and all who responded reinforced the importance of continuing education about supplements.

 



 

The Right Role for Doctors?

Diane Van Kempen, a retired schoolteacher from Franklin Lakes, N.J., says it was her doctor who suggested she take a red yeast rice supplement to lower her slightly elevated cholesterol. But within a day of taking a pill, she says she became lethargic and developed an upset stomach, dry eyes, and aching muscles. Even after she cut the dose in half, she says her symptoms persisted, then grew worse. Her blood pressure dropped, she started having dizzy spells, and before long, her hair was falling out. “That’s when I stopped taking the supplement,” she says.

Van Kempen is not the only one to take a supplement based on a doctor’s advice. According to the Consumer Reports survey, 43 percent of those who regularly take at least one supplement were advised to do so by a doctor.

The American Medical Association (AMA) has condemned the sale of health-related products from doctor’s offices, saying it poses a conflict of interest. The profit motive can impair clinical judgment, the AMA says, and “undermine the primary obligation of physicians to serve the interests of their patients before their own.”

Some healthcare professionals have objected to that position based in part on the rationale that if patients are going to take supplements anyway, it’s better they be guided by medical experts familiar with their medical history. “Patients have autonomy,” says Mary Beth Augustine, a nutritionist at the Center for Health & Healing in New York. “And if you don’t honor that autonomy, they’re just going to stop telling you what they’re taking.”

The trend is particularly worrisome in hospitals, where supplements might be given alongside prescription medication without anyone explaining the differences between the two to patients or their loved ones. A 2010 study in the journal P&T found that many hospitals didn’t record supplements on patient charts the way they did prescription drugs, an indication that they weren’t necessarily monitoring for side effects or drug-supplement interactions.

Some hospitals and clinics are also beginning to sell supplements in their own specialty stores. Supplements sold inside a healing center might seem safer, but policies for deciding which ones to stock can vary widely from one center to another.

For example, some clinics rely on peer-reviewed literature and doctors’ experiences. “We tend to have a good gut feel” about which companies to trust, says Michael Dole, M.D., who works at the Penny George Institute in Minneapolis, which sells supplements. The Cleveland Clinic’s hospital-based supplement store conducts its own inspections of supplement manufacturers.

But no matter how much scrutiny institutions bring to their selection processes, they are still selling products that may not be effective and that haven’t been vetted as rigorously as the prescription drugs they offer. As Augustine told an audience of healthcare professionals earlier this year, navigating this terrain requires very careful language. “I’m never going to say to a patient that [a supplement] is safe,” she said. “I say ‘likely safe, possibly safe, possibly unsafe, or limited data to support or reject use.’ Am I being overly cautious? Yes.”

Making Supplements Safer

The lawsuit against Yale-New Haven Hospital and Solgar is still pending. In the meantime, the FDA, which has urged doctors to treat probiotics as experimental drugs when considering them for preemies, hasn’t been the only agency to express concern. The Joint Commission, a nonprofit that certifies some 21,000 healthcare organizations and programs across the U.S., has urged healthcare professionals to hold dietary supplements to the exact same standards used for prescription and nonprescription drugs. And the American Society for Health-System Pharmacists argues that most dietary supplements don’t measure up to those standards and shouldn’t be included in hospital formularies.

“The right thing to do is to tell patients the truth,” says Arthur Caplan, Ph.D., a bioethicist at NYU Langone Medical Center. “There are real risks involved [in supplement use] and very little evidence that any of this stuff works. Period.”

Ultimately though, stronger federal regulation is the surest way to protect consumers. “Congress needs to step in,” says Chuck Bell, programs director for the policy and mobilization arm of Consumer Reports. “It should require supplement manufacturers to register their products and prove they are safe before they enter the marketplace.”

Some people say that major changes are going to be a tough sell. “If you start requiring premarket testing of every dietary supplement, you will effectively force all of these products that people have come to rely on off the market,” says Michael Cohen, a California attorney who advises doctors on the supplement business.

Still, there are a few signs that change is already afoot. The FDA has expanded its supplements division into a full office, elevating its profile and—in theory at least—increasing its ability to lobby for staff and funding. And Joshua Sharfstein, M.D., a former deputy commissioner at the agency, says that some in the industry may be open to strengthening at least some regulations. “We may be just one crisis away from that,” he says.

Supplements Proven Beneficial for Depression


One in 20 Americans over the age of 12 struggles with depression1 and 11 percent of the U.S. population over the age of 12 is on antidepressant medication.2 This, despite overwhelming evidence showing that antidepressants are no better than placebo in terms of effectiveness.

Story at-a-glance

  • Antidepressants work no better than placebo in terms of effectiveness. Studies now suggest their effectiveness can be boosted by adding certain supplements, but other studies suggest the supplements alone may do the trick
  • Fish oil, vitamin D, methylfolate (a form of folic acid/vitamin B9), and S-Adenosylmethionine (SAMe) were found to boost the impact of the antidepressants when compared to medication only
  • Other studies have shown that omega-3, vitamin D, and SAMe can help combat depression all on their own. In fact, both omega-3 and vitamin D are very important for mental health

As noted in a 2014 paper on antidepressants and the placebo effect, published in the journal Zeitschrift Fur Psychologie:3

“Antidepressants are supposed to work by fixing a chemical imbalance, specifically, a lack of serotonin in the brain. Indeed, their supposed effectiveness is the primary evidence for the chemical imbalance theory.

But analyses of the published data and the unpublished data that were hidden by drug companies reveals that most (if not all) of the benefits are due to the placebo effect …

Even the small statistical difference between antidepressants and placebos may be an enhanced placebo effect, due to the fact that most patients and doctors in clinical trials successfully break blind.”

Serotonin Theory Has Been Proven Wrong

Research4,5 published in 2009 added further evidence to the pile indicating the low serotonin idea was incorrect, as they found strong indications that depression actually begins further up in the chain of events in the brain. Essentially, the medications have been focusing on the effect, not the cause.

More recent research into the mechanisms driving anxiety and social phobias has also turned conventional drug treatment with serotonin reuptake inhibitors (SSRIs) on its ear.

As it turns out, these mental health problems are actually linked to elevated levels of serotonin in the amygdala, not low levels.6,7,8,9 Your amygdala is the seat of primitive emotions such as fear. And the more serotonin produced in this area, the more anxious you feel.

This helps explain why some depressed patients end up feeling more anxious than before when taking a serotonin-boosting antidepressant. As noted in the paper above:

The serotonin theory is as close as any theory in the history of science to having been proved wrong. Instead of curing depression, popular antidepressants may induce a biological vulnerability making people more likely to become depressed in the future.”

Vitamins and Supplements Boost Effectiveness of Antidepressants

A recent study10 raises even more questions about the effectiveness of antidepressants.

The meta-analysis, published in the American Journal of Psychiatry, found that certain nutritional supplements boosted the effectiveness of several classes of antidepressants, including SSRIs, serotonin-norepinephrine reuptake inhibitors (SNRIs) and tricyclic antidepressants.

A total of 40 clinical trials were included in the review, and four supplements — fish oil, vitamin D, methylfolate (an effective form of folic acid), and S-Adenosylmethionine (SAMe) — were found to boost the impact of the medication when compared to medication only.

Fish oil — specifically the fat EPA — produced the most significant improvement. Studies investigating the use of creatine, zinc, vitamin C, tryptophan (an amino acid), and folic acid (B9) produced mixed results. As reported by Scientific American:11

“By some estimates, two-thirds don’t respond to the first antidepressant they try and a third fail to get better after several treatment attempts.

‘The implications are that clinicians and the public can consider [adding] therapeutic doses of nutrients such as omega-3s as a potential low-cost approach to reducing depression in people who are non-responsive to antidepressants,’ (lead author Jerome Sarris) says.”

Could Supplements Alone Be Responsible for Improvements?

According to the authors, “more patients in the studies showed an improvement in mood when prescribed omega-3 fish oil, methylfolate, vitamin D and SAMe supplements in combination with antidepressant medication, compared to those who took medication only.”12

What’s really missing here is a comparison between supplements only, medication only, and a combination of both.

Considering the fact that antidepressants have been proven to be no better than placebo, and can worsen depression in some people, perhaps patients would experience the same or even better results just by taking the supplement, without the drug.

If that’s indeed the case, then why risk your health by taking an antidepressant? In fact, other studies have shown that bothomega-3 and vitamin D can help improve mental health all on their own.

One likely theory as to why they work is because these supplements help combat inflammation and oxidative stress, not only in your brain but also in your gut.

Depression is often found alongside gastrointestinal inflammation, autoimmune diseases, cardiovascular diseases, neurodegenerative diseases, type 2 diabetes, and cancer.

Chronic low-grade inflammation is a significant contributing factor to all of these, leading researchers to suggest that “depression may be a neuropsychiatric manifestation of a chronic inflammatory syndrome,” and that the primary cause of inflammation may be dysfunction of the gut-brain axis.13

An increasing number of clinical studies have indeed confirmed that treating gastrointestinal inflammation with probiotics, omega-3, and vitamins B and D can improve symptoms of depression by attenuating pro-inflammatory stimuli to your brain that originate in your gut.14

The Importance of Omega-3

Many Americans’ diets are lacking in healthy fats, including the animal-based omega-3 fats EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid). Although omega-3s are most well known for their role in heart health, they also play an integral role in brain health and mental health.

The 2001 book, “The Omega-3 Connection,” written by Harvard psychiatrist Dr. Andrew Stoll, was among the first works to bring attention to, and support the use of, omega-3 fats for depression.

There is no set recommended standard dose of omega-3 fats, but some health organizations recommend a daily dose of 250 to 500 milligrams (mg) of EPA and DHA for healthy adults. If you suffer from depression, higher doses may be called for.

In one study,15 an omega-3 supplement with a dose range of 200 to 2,200 mg of EPA per day was effective against primary depression. Omega-3 has also been shown to improve more serious mental disorders, including schizophrenia, psychosis, and bipolar disorder.16

Making sure you’re getting enough omega-3 in your diet, either from wild Alaskan salmon, sardines and anchovies, or a high-quality omega-3 supplement like krill oil is, I believe, absolutely crucial for optimal health, including brain health, so it doesn’t surprise me in the least that it was found to be the most effective addition against depression.

Low Vitamin D Repeatedly Linked to Depression

Vitamin D receptors appear in a wide variety of brain tissue early in the fetal development, and activated vitamin D receptors increase nerve growth in your brain. Researchers believe that optimal vitamin D levels may enhance the amount of important chemicals in your brain and protect brain cells by increasing the effectiveness of the glial cells in nursing damaged neurons back to health. As noted by the Vitamin D Council:17

“Exactly how vitamin D works in the brain isn’t fully understood. One theory is that vitamin D affects the amount of chemicals called monoamines, such as serotonin, and how they work in the brain. Many anti-depressant medications work by increasing the amount of monoamines in the brain. Therefore, researchers have suggested that vitamin D may also increase the amount of monoamines, which may help treat depression.”18

Regardless of the exact mechanism, a number of studies have linked low vitamin D to depression, including the following:

  • Seniors with the lowest levels of vitamin D have been found to be 11 times more prone to be depressed than those who had normal levels.
  • A study19 conducted by VU University Medical Center in Amsterdam found that people with minor and major depression had on average 14 percent lower vitamin D levels than non-depressed participants.
  • In another study,20 people with vitamin D levels below 20 ng/mL had an 85 percent increased risk of depression compared to those with vitamin D levels greater than 30 ng/mL.
  • Vitamin D deficiency has long been associated with Seasonal Affective Disorder (SAD)21 and, in 2007, researchers noted that vitamin D deficiency is associated with depression and fibromyalgia.22
  • A double-blind randomized trial23 published in 2008 also concluded that: “It appears to be a relation between serum levels of 25(OH)D and symptoms of depression. Supplementation with high doses of vitamin D seems to ameliorate these symptoms indicating a possible causal relationship.”

Other Supplements and Habits Shown to Lessen Depressive Symptoms

SAMe is an amino acid derivative that occurs naturally in all cells. It plays a role in many biological reactions by transferring its methyl group to DNA, proteins, phospholipids and biogenic amines. Several scientific studies indicate that SAMe may be useful in the treatment of depression.

5-Hydroxytryptophan (5-HTP) is another natural alternative to traditional antidepressants. When your body sets about manufacturing serotonin, it first makes 5-HTP. Taking 5-HTP as a supplement may raise serotonin levels.

The evidence suggests 5-HTP outperforms a placebo when it comes to alleviating depression24 — more than can be said about antidepressants! However, keep in mind that anxiety and social phobias can worsen with higher levels of serotonin, so it may be contraindicated if your anxiety is already high. St. John’s Wort has also been shown to provide relief from mild depressive symptoms.

While the featured study found some benefit from methylfolate, vitamin B12 deficiency can also contribute to depression, and affects about 1 in 4 people. If you’re curious about methylfolate read through this quick summary of its side effects.25 Vitamin B12, on the other hand, is sorely needed by many, and if you’re deficient, may help lessen symptoms of depression. Additionally to the best of my knowledge there have never been any overdoses of vitamin B12. It’s incredibly safe.

Many also suffer from “exercise deficiency,” and exercise is one of the most potent anti-depressants at your disposal. Research has confirmed it actually outperforms drug treatment. It’s also a key treatment strategy for anxiety disorders.

Exercise primarily works by helping to normalize your insulin levels while simultaneously boosting “feel good” hormones in your brain. But researchers have also recently discovered that exercise helps your body eliminate kynurenine, a harmful protein associated with depression.26

And, confirming the link between inflammation and depression, your body metabolizes kynurenine in the first place via a process that is activated by stress and inflammatory factors. Additionally, exercise increases BDNF (brain-derived neurotropic factor) and is a powerful activator of mitochondrial biogenesis.

Key Factors to Overcoming Depression and Anxiety Without Drugs

It’s important to realize that your diet and general lifestyle are foundational factors that must be optimized if you want to resolve mental health problems such as depression or anxiety, because your body and mind are so closely interrelated. For example, while many think of their brain as the organ in charge of their mental health, your gut may actually play a far more significant role.

The drug treatments available today for depression fail miserably in addressing people’s mental health problems. While adding one or more supplements to the treatment protocol is a step in the right direction, it still falls short, as the side effects of these drugs can be worse than the original complaint, running the gamut from sexual side effects to lack of emotions or “emotional flatness,” restlessness, sleep disturbances, brain damage, and even to suicide and homicide.

Antidepressants can also result in chronic, long-term, and worsening depression, so ideally, you’ll want to avoid them unless absolutely necessary.

Since antidepressants are on par with placebo in terms of effectiveness, wouldn’t it make sense to try something else first? Your diet is an obvious place to start. Research tells us that the composition of your gut flora not only affects your physical health, but also has a significant impact on your brain function and mental state, and your gut microbiome can be quickly impacted by dietary changes — for better or worse.

Research has also revealed there are a number of other safe effective ways to address depression that do not involve hazardous drugs. So, if you suffer from an anxiety or depression-related disorder, please consider addressing the following diet and lifestyle factors before you resort to drugs:

Eat real food, and avoid all processed foods, sugar (particularly fructose), grains and GMOs

High sugar and starchy carbohydrates lead to excessive insulin release, which can result in falling blood sugar levels, or hypoglycemia. In turn, hypoglycemia causes your brain to secrete glutamate in levels that can cause agitation, depression, anger, anxiety, and panic attacks.

Sugar also fans the flames of inflammation in your body. In addition to being high in sugar and grains, processed foods also contain a variety of additives that can affect your brain function and mental state, especially MSG, and artificial sweeteners such as aspartame.

Gluten sensitivity is also a common, hidden cause of depression, so going on a gluten-free diet can be part of the answer. Recent research also shows that glyphosate, used in large quantities on genetically engineered crops like corn, soy, and sugar beets, limits your body’s ability to detoxify foreign chemical compounds.

As a result, the damaging effects of those toxins are magnified, potentially resulting in a wide variety of diseases, including brain disorders that have both psychological and behavioral effects.

Increase consumption of traditionally fermented and cultured foods

Reducing gut inflammation is imperative when addressing mental health issues,27 so optimizing your gut flora is a critical piece. To promote healthy gut flora, increase your consumption of probiotic foods, such as fermented vegetables, kimchee, natto and kefir.

Get adequate vitamin B12

Vitamin B12 deficiency can contribute to depression and affects one in four people.

Optimize your vitamin D levels

Vitamin D is very important for your mood. Remember, Seasonal Affective Disorder is a type of depression related to sunshine deficiency, so it would make sense that the perfect way to optimize your vitamin D is through UV exposure. Be sure to check your levels (via blood test) at least once or twice a year. You’ll want to be within the therapeutic range of 40 to 60 ng/ml year-round.

If you cannot get sufficient sun exposure to maintain this level, taking an oral vitamin D3 supplement would be advisable. Just remember to also increase your vitamin K2 when taking oral vitamin D.

Get plenty of high-quality animal-based omega-3 fats

Your brain is 60 percent fat, and DHA, an animal-based omega-3 fat, along with EPA, is crucial for good brain function and mental health28,29 Unfortunately, most people don’t get enough from diet alone, so make sure you take a high-quality omega-3 fat, such as krill oil.

Evaluate your salt intake

Sodium deficiency actually creates symptoms that are very much like those of depression. Make sure you do NOT use processed salt (regular table salt), however. You’ll want to use an all natural, unprocessed salt like Himalayan salt, which contains more than 80 different micronutrients.

Get adequate daily exercise

Studies have shown there is a strong correlation between improved mood and aerobic capacity. There’s also a growing acceptance that the mind-body connection is very real, and that maintaining good physical health can significantly lower your risk of developing depression in the first place.

Exercising creates new GABA-producing neurons that help induce a natural state of calm. It also boosts your levels of serotonin, dopamine, and norepinephrine, which help buffer the effects of stress.

Get enough sleep

You can have the best diet and exercise program possible but if you aren’t sleeping well you can easily become depressed. Sleep and depression are so intimately linked that a sleep disorder is actually part of the definition of the symptom complex that gives the label depression.

Energy psychology

Energy psychology techniques such as the Emotional Freedom Techniques (EFT) can also be very effective for reducing symptoms of depression or anxiety by correcting the bioelectrical short-circuiting that causes your body’s reactions — without adverse effects.

Recent research has shown that EFT significantly increases positive emotions, such as hope and enjoyment, and decreases negative emotional states. EFT is particularly powerful for treating stress and anxiety because it specifically targets your amygdala and hippocampus, which are the parts of your brain that help you decide whether or not something is a threat.30,21

For serious or complex issues, seek out a qualified health care professional that is trained in EFT32 to help guide you through the process.

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