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RT @MargauxVega I knew FRS (client) was awesome! New study shows... - Kind of sounds like she made up her mind a head of time, no?

This is the second post I've written about the antioxidant quercetin, and the FRS line of energy products. In the first post titled "Lance Armstrong, LIVESTRONG, and FRS" I argued that it was inappropriate to use LIVESTRONG, a brand associated with the Lance Armstrong Foundation, a respected cancer charity, to promote FRS, a line of energy supplements (canned drinks, liquid concentrate, drink mix, and soft chews).

FRS makes various claims about the health benefits of their product, including "extending your body's natural energy" and "supporting your health over the long haul". The key ingredient in FRS, and according to the company the product's "secret weapon", is a special variety of quercetin, an antioxidant which is found naturally in a variety fruits and vegetables, (e.g. apples, onions, broccoli, blueberries, red grapes). The problem with that association is that there is a widely held, but unsubstantiated, belief that antioxidants help to prevent cancer. (This is due in large part to the unsubstantiated claims of makers of supplements.) This supposed relationship has simply not been proven.

In my opinion, it is morally suspect for a figure like Armstrong, who is seen as a respected member of the cancer community, and someone with links to cancer research through his association with The Lance Armstrong Foundation, to don a LIVESTRONG jersey and promote FRS for the purposes of making money for himself.

This second post is in response to the following tweet published by Twitter user @MargauxVega:

I knew FRS (client) was awesome! New study shows FRS's key ingredient, quercetin increases endurance & VO2max http://tinyurl.com/n42r95

The link references a newswise article titled "Qercetin Increases Endurance without Regular Exercise Training", which is itself a brief overview of an article titled "The Dietary Flavonoid Quercetin Increases VO2max and Endurance Capacity" which appeared on June 24th, 2009 as an 'online preview article' for the International Journal of Nutrition and Excercise Metabolism.

Apparently for @MargauxVega (a consumer PR rep who counts FRS as a client) this study is sufficient evidence of the effectiveness of the FRS line of products. Before you decide that you agree with her, and start on the recommended (by FRS) regimen of 2-3 servings a day ("one in the morning, one in afternoon, and another before exercise or whenever you need an energy boost"), you may have to consider the following:

1. The study that is the subject of the IJSNEM article did not evaluate FRS. According to the abstract, "volunteers were randomly assigned to 1 of 2 treatments: (a) 500 mg of quercetin twice daily dissolved in vitamin-enriched Tang or (b) a nondistinguishable placebo (Tang)".

Of course, this means that if there are any real, appreciable benefits to taking quercetin supplements, they have nothing to do with "FRS's revolutionary blend of nutrients...". Any quercetin supplement should have exactly the same effect. (Keep in mind that's a big if.)

2. Other quercetin supplements are much, much cheaper. For example GNC offers "GNC Quercetin 500" which is a container of 60 500mg tablets, that sells for the regular price of $13.49. That drops the price of "The Science of 13.2%" touted on the FRS website, from $216 a month to $13.50 a month (also compare $2595.15 per year for the FRS solution to $161.88 for the alternative). This study offers no data to support the claim that either product is more effective than the other. Substitute Quercetin 1000mg by KAL which I found online for $12.01 and the price drops to $144.12 per year, which represents a 95% discount in comparison to the cost of the FRS product.

Again I want to be very clear that I am not recommending that anyone use any of these supplements!

3. The claim that "quercetin, a key ingredient in FRS Healthy Energy products, has been shown in a new clinical study to increase endurance by 13.2 percent and VO2max, a typical measure of fitness, by 3.9% - so you can do more and go farther", is based on a single study.

If we're being honest, a single preliminary study is insufficient evidence to establish anything. It's very likely that your doctor, or any reputable medical professional, would tell you to completely disregard this result until it can be confirmed by a number of studies.

4. The study being referenced reports on a total of twelve (12) volunteers, over a period of seven (7) days. This is relatively small group and short timeframe. It may be difficult to draw any valid conclusion from such a small scale study.

5. Without having access to the full article it is impossible to make a judgement about selection bias, number of drop outs among participants, and other crucial information related to the design and execution of the study.

Do not draw any conclusions whatsoever until you have the opportunity to review the paper. The information available at frs.com, newswire.com, and publicly available at the IJSNEM website is insufficient to evaluate the study and so we can make nothing of the results. I am not suggesting that the study is invalid, but I am saying that without additional information it is impossible for anyone to evaluate its validity. So, if you've read the paper documenting the study completely, and considering that info you're satisfied with a 7 day study involving twelve participants, then you're certainly entitled to that opinion. However, you should not base your evaluation of the study of FRS's claims based only on the information I've seen (the information linked to in this post).

By the way, I have tried to get a hold of the full paper. Unfortunately, the journal is a little hard to come by. It's not available online in the collections at MIT, Harvard, or Tufts. Apparently, it is available in print format at Harvard's Medical School library. Still, this is perhaps not the go to journal for the field. What's more, the paper is not yet available in the print journal. Currently the article is available only as an 'online preview article' at the journal's website.

6. In addition to quercetin the "revolutionary blend of nutrients" in FRS products include large amounts of nutrients typically found in multivitamins and fortified products.

Consider for example the contents of an 11.5 oz can of FRS lemon lime:

Calories 130  
Total Carbohydrates 34g, 11%  
Sugars 29g  
Dietary Fiber 2g, 8%  
Vitamin C 166mg, 280%  
Vitamin E 81IU, 270%  
Thiamin 2mg, 130%  
Riboflavin 2mg, 130%  
Niacin 26mg, 130%  
Vitamin B6 3mg, 130%  
Vitamin B12 8mcg, 130%  
Quercetin 325mg  
Catechins 85mg  

The product also contains 48mg of caffeine.

To the best of my knowledge, there is nothing especially alarming about these ingredients in these quantities, but there is certainly nothing revolutionary about them either, and no reason to believe this particular blend will lead to any especially beneficial result.

It should be noted that taking larger than the recommended amount of nutrients is typically of no value. At best, all of the extra is simply wasted, i.e. not absorbed, and passed harmlessly through your system. However, megadoses of nutrients can have adverse effects ranging from diarrhea to death.

Starting in 1997 the U.S. Institute of Medicine established a reference called the "Tolerable Upper Intake Level" (UL) for selected nutrients. The UL is the highest level of daily nutrient intake likely to pose no risk of adverse health effects for almost all individuals in the general population and is not meant to apply to people under medical supervision.

Below are the “safe intakes” for nutrients in FRS. Note that these are values for adults only. Levels for infants, children, and adolescents are often considerably lower.

UL Per day  

Vitamin C - 2000mg  
Vitamin E - 1000mg  
Thiamin - no adverse effects  
Riboflavin - no adverse effects  
Niacin - 35 mg  
Vitamin B6 - 100 mg  
Vitamin B12 - no adverse effects

As I've already said, the levels of these nutrients in FRS are all well below safe intake levels. Still keep in mind that FRS recommends 3 or more servings per day. The total nutritional info for three servings looks like:

Calories 390  
Total Carbohydrates 102, 33%  
Sugars 87g  
Dietary Fiber 6g, 24%  
Vitamin C 498mg, 840%  
Vitamin E 243IU, 810%  
Thiamin 6mg, 390%  
Riboflavin 6mg, 390%  
Niacin 78mg, 390%  
Vitamin B6 9mg, 390%  
Vitamin B12 24mcg, 390%  
Quercetin 975mg  
Catechins 255mg

The nutritional content of 3 servings is certainly excessive, even if not dangerous. Keep in mind that some of the foods you eat may be fortified with large amounts of these same nutrients. Furthermore, keep in mind that if you're also taking a multivitamin you may push daily intake of some of these to as much as 1000% of the recommended dietary intake (RDI).

7. I have yet to see even a single medical doctor, who is not somehow collecting money from the company, recommend that people put themselves on a daily regimen of FRS products, as FRS advises. Don't take my word for it though. Ask your own doctor.

8. The prevailing opinion of the medical community is close to the following, which comes from the American Cancer Society:

Until conclusive clinical research findings emerge, it is reasonable to include foods that contain quercetin as part of a balanced diet with an emphasis on fruits, vegetables, legumes, and whole grains. The interaction between certain phytochemicals and the other compounds in foods is not well understood, but it is unlikely that any single compound offers the best protection against cancer. A balanced diet that includes 5 or more servings a day of fruits and vegetables, along with foods from a variety of other plant sources such as nuts, seeds, whole grain cereals, and beans, is likely to be more effective in reducing cancer risk than eating one particular phytochemical in large amounts.

Keep in mind that fruits and vegetables contain many naturally occurring substances that may help protect against chronic health conditions, improve quality of life, and help to reduce the effects of aging. The precise nature of the relationship between eating a diet rich in fruits and vegetables and and the associated health benefits is not well understood, much less the interactions among all of the substances found in these foods. Consider this quote from the article "Fruits and vegetables: better than supplements":

Fruits and vegetables contain hundreds of phytochemicals that help promote health and prevent disease, said Karen Elliott. These phytochemicals are easily absorbed to provide maximum health benefits. In contrast, common dietary supplements contain large doses of only one or two phytochemicals. Moreover, supplements do not have to undergo testing for safety and effectiveness.

Phytochemicals are natural compounds found in plants. Research suggests that phytochemicals, working with nutrients found in fruits, vegetables and nuts, may reduce the effects of aging and lower the risk of many diseases, including cancer, diabetes, heart disease, stroke, high blood pressure, arthritis, cataracts, osteoporosis and urinary tract infections.

9. Finally, for anyone who is swayed by the sort of preliminary studies and superficial science presented by FRS, you might be interested to know that the earliest studies involving quercetin suggested that it might actually help to cause cancer.

From the American Cancer Society website

Quercetin first gained attention several decades ago when it was found to cause DNA mutations in bacteria, a sign that it might actually contribute to causing cancer. Animal research done since that time has been inconclusive, and what little evidence there is in humans does not seem to support this idea. Research in recent years has focused on several possible helpful effects of quercetin.

The lesson? Preliminary studies are part of a process that leads to a better understanding of what are very complex issues. The data should be considered inconclusive at best. Assumptions based on this data are frequently proven to be wrong, sometimes dangerously so, on further study. As such, it might be considered improper to promote products based on early data.