Marketing claims vs. nutritional science: exploring the science behind some of the claims made by a popular sports nutrition product.
If you read the above claims/statements, do you think that your interest would be piqued? What if you were a new athlete? Would the promise of advanced science, especially the advanced oral delivery system be one that spoke to you?
I know as a scientist--one familiar with drug delivery technology--that new or more effective modes of delivering any agent is of tremendous interest. For the public this is true too; just note the rapid rise in sales for products that were once pills and are now available as dissolvable films.
It is imperative to review how good science is performed in order to determine if a product--and the hype surrounding it--is worth its weight in scientific substantiation.
The Olympics & Latvia
If you had a chance to watch the Olympics, held in Italy this year, you would have realized just how amazing these athletes are. Having attended some of the Olympic events myself, I can say firsthand that some of these athletes are simply remarkable.
One company that obtained sponsorship approval for the Netherlands contingent at these Olympic games was DSM, which was busy promoting its PeptoPro recovery product. Another company active on the Olympics front was Muscle Marketing USA (MMUSA). Following the winter games, the company issued a press release claiming its Creatine Serum product "powered" the Latvian team to a medal (1). In fact, Dr. Amir Zeiback, CEO, went as far as to say: "The Latvians worked with our distributor partners Nutriworld in the Netherlands and are using a full range of our fitness, endurance and strength products. The explosive power and energy Creatine Serum delivers has never had a more widely-viewed showcase."
Speaking of Creatine Serum, let's take a look at the published science on this popular product.
Liquid chromatography (LC) is one method used in bench (laboratory) science to determine the presence of a particular agent or product. Often we hear about an athlete testing positive for a drug when they had no idea there were any drugs in the "supplement" they were taking. Labs will use LC to determine such substances in a supplement. Perhaps your company has even had its product(s) analyzed for content. It is quite possible the lab used LC for such a purpose. While there are many analytical methods employed by laboratories, LC is most often used because it is among the most reliable.
Putting Creatine to the Test
In 2002, Creighton University Department of Pharmacy Sciences tested various creatine products for actual creatine and creatinine (a downstream metabolite in the urine of creatine). They also tried to determine whether LC could be used on a wide variety of creatine products.
The study authors tested creatine powder (Creatine Edge and Creatine Clear by FSI Nutrition), liquid creatine (Creatine Serum from MMUSA) and another powdered creatine (Sigma) (2). The testing method used was high performance liquid chromatography (HPLC) with ultraviolet (UV) detection of creatine and creatinine in the products.
The researchers also attempted to quantify the product contents as compared to the label claims. They set out to determine the amount of creatine and creatinine in each product, as well as their relative solubility. (Solubility is very important. If something does not dissolve, what good is it to your customer?) Shelf-life of the products when mixed with water (if a powder) versus the Creatine Serum was also noted by the researchers.
The results indicated that Creatine Serum contained less than 2% of the amount of creatine claimed on the label, and that the product was made up mostly of creatinine. Unfortunately, ingesting creatinine is useless for an athlete. Thus, from this one analytical study it is evident that the MMUSA product sold as Creatine Serum is mostly liquid and creatinine, not creatine. But just in case the HPLC analysis missed something, a human absorption study was undertaken.
The Exercise and Sports Nutrition Laboratory at Baylor University (Director, Richard Kreider, PhD) designed a clinical trial with 40 subjects to determine if Creatine Serum, as opposed to creatine monohydrate powder, would produce any differential effects as related to muscle levels of creatine, adenosine triphosphate (ATP) and other related biomarkers (3).
The technique employed for the analysis of creatine, ATP and other metabolites in the muscle included the percutaneous muscle biopsy under standardized conditions. All subjects ingested their assigned products at varied dosages. Those assigned to the liquid creatine product were randomized to receive doses up to eight times the label amount. The control group received 20 grams of creatine monohydrate daily. The supplementation period was five days. Muscle biopsies were taken prior to and after supplementation. The study results indicated that no matter what level of supplementation given, the Creatine Serum product produced no change in creatine, free creatine, and total creatine or ATP levels. The powdered creatine monohydrate product did significantly increase intramuscular creatine and phosphagen stores. Thus, according to this study, Creatine Serum is not a more effective form of creatine.
Now that there was evidence that Creatine Serum had no effect on actual muscular levels of creatine, researchers wondered if the product delivered any creatine (in the bloodstream) to a person taking it. The product claims to have the equivalent of 2500 mg (2.5 grams) of creatine in every 5 ml of liquid (4).
A research group based in the U.K. purchased three samples of Creatine Serum and assayed the products for creatine at four different laboratories, while also having two of the laboratories analyze the product for creatinine content. In addition, six male study subjects ingested either creatine, Creatine Serum or placebo in random order over three-week period. The scientists collected blood and urine at specific time points and analyzed for the appropriate contents.
The findings of this U.K. study supported the U.S. findings. In fact, the multiple laboratory analysis noted that Creatine Serum contained less than 10 mg actual creatine monohydrate and 90 mg creatinine. From the serum analysis, only the creatine monohydrate, not the liquid product, positively impacted and affected serum or urinary levels of creatine. Thus, from these studies, it can be concluded that Creatine Serum does not appear to be an effective creatine supplement.
If one wanted to determine if a finished product truly had any efficacy as claimed, the ideal situation would be to conduct a randomized, double-blind, placebo-controlled clinical trial. The study should be sufficiently powered so that it can easily be ruled out that the results are not due to chance alone and that the testing methods are reproducible. Again, in an ideal world, one tests a finished product by having the study participants follow label instructions on how and when to use the product.
Since creatine is purported to aid in the production and recovery of high-energy phosphates (via increased phosphocreatine resynthesis), a study that tested the effects of the supplement on high intensity exercise would be a nice fit. This was precisely the approach taken by scientists from Salisbury when they wanted to determine if Creatine Serum had any effect on 5000 meter run times in cross-country athletes (5).
Creatine Serum is also marketed as Runner's Advantage. Obviously, the name is meant to get those in the running community interested in this dietary supplement. Like anaerobic sports, high intensity running also taxes the body's metabolic energy systems.
In this study, cross-country runners from a university completed a pre-supplementation 5000 meter run and then received either the active product or placebo 10 minutes prior to running--following the manufacturer's dosage instructions--on their test days. The 5000 meter run was followed by a time to exhaustion trial. This provided researchers with many opportunities to see if the liquid creatine was any better than placebo for exercise performance.
The scientists did not find an ergo-genic effect of Runners Advantage Creatine Serum since there was no effect on 5000 meter run time. In fact, the study authors noted that the runners had a tendency to run slower after taking the test product (as compared to baseline values and placebo). Thus, this performance trial did not support the marketing and usage of this supplement for competitive runners. Interestingly, the product used, as well as the funding for this study, was supplied by MMUSA.
The Legal Side
We all know that it is important for companies to directly undertake human clinical trials in order to determine if the products they sell are safe and efficacious. Clearly, as demonstrated in this column, the studies on Creatine Serum do not support the claims made by MMUSA, and in fact, courts have noted this in actions against the company (6,7).
The proper formulation of a product, coupled with the smart design of at least two-well-controlled clinical trials is now necessary (as it should've been all along) in order to make sure that your brand grows with the support of science, rather than be hampered by smoke and mirrors. One does not need to start with a randomized, double-blind, placebo-controlled clinical trial, especially if you have not done any human interventional work to date. Start with a proof of concept study at a reputable clinical research center or university in order to build your data and intellectual property (IP) platform, while investing in additional larger studies if your initial data reveals positive trends and/or significance. It is obvious from reading the press release issued after the 2006 Winter Olympics that unless MMUSA has drastically changed its formulation of Creatine Serum, the science still does not support its product claims.
1. www.creatine.com (News) Accessed March 6, 2006.
2. Dash AK, Sawhney A. A simple LC method with UV detection for the analysis of creatine and creatinine and its application to several creatine formulations. J Pharm Biomed Anal 2002;29:939-945.
3. Kreider RB, Willoughby D, Greenwood M, Parise G, Payne E, Tarnopolsky MA. Effects of serum creatine supplementation on muscle creatine and phosphagen levels. JEPOnline, 2003 6(4):24-33.
4. Harris RC, Almada AL, Harris DB, Dunnett M, Hespel P. The creatine content of Creatine Serum and the change in plasma concentration with ingestion of a single dose. J Sports Sci, 2004;(9):851-857.
5. Astorino TA, Marrocco AC, Gross AM, Johnson DL, Brazil CM, Icenhower ME, Kneessi RJ. Is running performance enhanced with creatine serum ingestion? J Strength Cond Res, 2005;19(4):730-734.
6. U.S. District Court Issues Injunction against MMUSA in Suit Brought by Degussa Bioactives. January 23, 2004. Accessed from www.npicenter.com.
7. Muscle Marketing USA fined $70,000 for false claims about sports performance product. July 14, 2004. www.common.gov't.nz/publications/display_mr.cfm?mr_id=1364.
Douglas Kalman, MS, RD, FACN, is director of clinical nutrition at Miami Research Associates (MRA), Miami, FL, in the Nutrition and Endocrinology Division. MRA is a clinical service organization involved for over 10 years in phase II through post market trials for the pharmaceutical and nutraceutical industries. Mr. Kalman is also an active member of the American College of Sports Medicine, American College of Nutrition, the American Dietetic Association, the National Strength and Conditioning Association and the Association of Clinical Research Professionals. He is also the executive vice president and treasurer of the International Society of Sports Nutrition (ISSN). He can be reached at 305-666-2368; Fax: 305-669-8966; E-mail: firstname.lastname@example.org; Website: www.miamiresearch.com.
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|Title Annotation:||THE RESEARCH PROCESS|
|Date:||Apr 1, 2006|
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