Piranha in the Shark Tank: An overview of pseudo health claims, unregulated weight loss supplements, and modern pharmaceutical intervention for the treatment of obesity

| June 1, 2018

by Stephanie R. Therrien, BSc

Bariatric Surgery Department, Beth Israel Deaconess Medical Center, Boston, Massachusetts

Funding: No funding was provided for this article.

Disclosures: The author reports no conflicts of interest relevant to the content of this manuscript.

Bariatric Times. 2018;15(6):8–11.

Introduction

On January 21, 2018, in a unanimous decision, the biggest deal in the history of ABC’s television show Shark Tank was struck. An astonishing $1.3 million and a 25-percent shareholder investment was bestowed upon contestants and sisters Anna and Samantha Martin for their product—a weight loss pill called “CLA Safflower Oil.” The pitch claimed that the product naturally slows the production of fat, eliminates cravings, and increases metabolism, serotonin, and energy levels. The pair were the first contestants in the show’s long duration to ever receive a standing ovation and offers of investment from all five panel members. 

Have you opened your internet browser page to purchase a bottle yet? Or, does it sound too good to be true?

A Piranha in the Shark Tank

If you chose “too good to be true,” you’d be correct. What you’ve just read was the introductory paragraph from an article titled “Weight loss pill that naturally burns fat gets biggest deal in Shark Tank history.”1 This article is widely circulated and can be found on several different websites via a Google search. No matter the website you choose, if you click on any of the hyperlinks embedded within the article you will be immediately redirected to the product’s website, with abundant spectacular claims. The names of the entrepreneurs (though still referenced as having been on Shark Tank) vary per article, as does the product name, though the picture and claims remain the same. Neither the article nor product were ever actually on or endorsed by Shark Tank. The two sisters pictured in the article and referenced as having created the product CLA Safflower Oil are actually Shelly Hyde and Kara Haught, who went on Shark Tank to pitch their women’s swimwear business.2

What is the significance of this seemingly unimportant article? Shark Tank is a multi-Emmy award-winning reality TV show where selected aspiring entrepreneurs are afforded the opportunity to present their products to wealthy investors. It has a reputation of being a show that truly vets its contestants, as well as their products. In 2016, market data estimated that the total United States weight loss market profits were on the order of $66.3 billion.3 With those numbers, it is not hard for one to imagine that a show like Shark Tank would be interested in gaining a foot in this market, and therefore an article, such as the one mentioned above, might influence its readers to believe the product and its weight loss claims to be real. 

Targeted Marketing to Dieters

While Shark Tank has nothing to do with the previously mentioned article, and is neither the first nor the last company to have its name and reputation used illegitimately, the title of the show does happen to be the perfect metaphor for the world of dieting, where big names (sharks) have already struck claim in the daily lives of dieters through targeted marketing and advertising. 

While “click-bait” articles are abundant in every realm of the internet, the profitability and demand for weight loss products has brought on the infiltration of “piranhas” (unregulated, untested products and scam artists) into the “shark tank” world of dieting. The presence of these piranhas is not new to healthcare marketing or advertising industries. In the case of weight loss supplements, spectacular claims, such as “stops fat production” and “boosts metabolic speed,” are made to draw unsuspecting consumers. When you take into consideration that, according to the Obesity Action Coalition (OAC), 50 percent of people with obesity have never had a conversation about weight with a healthcare provider (HCP) and nearly as many say that their HCPs have never offered them weight loss management counseling,4 it comes as no surprise that people could fall victim to such well thought-out, heavily promoted, targeted ploys. 

The Dietary Supplement Health and Education Act (DSHEA) of 1994 was enacted by the 103rd United States Congress in an effort to define and regulate dietary supplements after the Nutrition Advertising Coordination Act of 1991 was overturned by lobbying food companies who sought to prevent the banning of dietary supplements entirely and what they viewed as “over-arching” government control of the food industry. This new act defined dietary supplement as a supplement that contains one more dietary ingredients, including but not limited to vitamins, minerals, and herbs, to supplement the diet by increasing daily intake.5 Under this new act, federal regulations require that several stipulations be met prior to a product appearing on store shelves. Unfortunately for consumers, these stipulations only cover the labeling of a product. As long as the product displays the following disclaimer: “This product has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease,” it does not, by law, have to undergo any validating research or present empirical evidence before it and its health claims can be marketed and sold to consumers.5 Upon retail, a product needs to be able to provide reasonable evidence of its safety—the methodology of which is not expanded upon and not tightly regulated since these products bypass United States Food and Drug Administration (FDA) inspection. Because of the laxity of these regulations, many weight loss products have come to market with unrealistic claims and high price tags but zero evidence-based results of their efficacy. In the last decade alone, the Federal Trade Commission has brought more than 80 law enforcement actions against companies making deceptive weight-loss claims.5

A Brief History of Weight Loss Supplements

Clinicians and healers have been utilizing and prescribing a wide range of weight loss regimens for centuries. As early as 500 BCE, the dangers of obesity started to be recognized. Indian physician Sushruta wrote of a disease he called madhumeha. His observations included that madhumeha seemed to “cause ‘a sweet taste and smell like that of honey,’ emaciation, a dryness of the body, excess thirst, and loss of appetite.” Today, we know madhumeha as diabetes mellitus.6 Health risks associated with obesity were noted by Greek physician Hippocrates in 460–377 BCE. During this time, the earliest anti-obesity recommendations on diet and exercise were born and included the use of the following: emetics (hellebore plants, honey), cathartics (bindweed, Cnidian berry), and laxatives (donkey milk, wild parsley, and dodder of thyme).6

In the late 1800s, weight loss regimens began to modernize. In 1894, British physician Nathaniel Edward Yorke-Davies began documenting weight loss in patients with obesity after he had given them desiccated thyroid. Following his example, other clinicians began to experiment with desiccated thyroid, combining it with strychnine and other hazardous drugs in an attempt to enhance its effect on weight loss. 

A little over a century later, the 1940s brought with it newly discovered anorectic effects of amphetamine, which generated tremendous interest among physicians and pharmaceutical firms who sought to capitalize on its use for weight loss.7 In 1941, The Clark & Clark Company of Camden, New Jersey, became one of the earliest manufacturers of diet pills (known as Clarkotabs) that combined amphetamine sulfate and desiccated thyroid extract along with phenobarbital, aloin (an aloe extract used as a laxative), and atropine sulfate.8 The use and abuse of Clarkotabs regimens, often referred to as “rainbow pills,” led to articles in magazines such as TIME criticizing “fat doctors” and detailing the health risks through which men and women were putting themselves to achieve the “ideal” Hollywood-propagated physique.

Since the 1940s, the numbers of weight loss supplements have only increased. To name a few; diethylproprion (1959), amphetamine (1979), 2,4 dinitrophenol (1980s), fenfluramine and dexfenfluramine (1997), sibutramine (1997–2010), orlistat (1999), and beta-methlyphenethylamine (2011). As of 2017, there are now over 10 FDA-approved and regulated anti-obesity medications on the market. Fortunately for consumers, 21st century physician-prescribed anti-obesity medications are vetted through rigorous clinical trials and FDA regulatory measures.

According to the National Health and Nutrition Examination Survey (NHANES), in 2014, 37.9 percent of American adults had obesity.9 In a world where the difficulty in maintaining weight loss induced by diet alone has been well-researched and documented, and rates of patients with obesity continue to rise, it is the duty of healthcare providers to not only coach patients on weight loss efforts, but to also aid in building a fact-based understanding of evidence-based weight loss treatments among the general public. While the role of functional foods, vitamins, minerals, and other supplementation should always be considered when discussing weight loss options, it is important as a provider to be familiar with and understand the mechanisms and efficacy of such supplements before promoting them for weight loss. 

Non-FDA Regulated Supplements You Should Know

Garcinea cambogia. Claim: Promotes satiety, prevents fat production, controls blood sugar and cholesterol levels. Active ingredient: Hydroxycitric acid (HCA), thought to block enzyme citrate lyase and boost serotonin levels. Clinical results: In a literature search from 1950 to 2017, there were only eight randomized, double-blind, placebo-controlled trials that sought to evaluate the effects of garcinea cambogia on body weight in patients with obesity.10 Of those publications, there were notable weaknesses around the assessment and reporting of weight loss maintenance, sufficient sample sizes, patient demographics, and doses of garcinea cambogia administered. In a further analysis of those eight studies, a borderline statistically significant mean difference in weight loss favoring HCA over placebo use was found (mean difference: –0.88kg; 95% confidence interval [CI]: –1.75 to 0kg; p=0.05). However, this result was not statistically significant when run through a sensitivity analysis. Summary: In lieu of poor data collection, variance in populations studied, and lack of long-term research, it is difficult to conclude whether this supplement has any real, long-term effect on weight loss.

Conjugated linoleic acid (CLA). Claim: Fat loss, weight loss, glycemic control. Active Ingredient: A naturally occurring group of positional and geometric linoleic acid isomers (cis-9, trans-11 and cis-12, trans-10).Clinical results: A study published in the International Journal of Obesity found that during a one-year study where 101 test subjects received 3.4g of CLA (t10, c12) supplementation daily, there was no statistically significant effect on the prevention of weight or fat regain.11 In a meta-analysis of 18 studies that evaluated the effect of CLA on weight loss, regain, and glycemic control, only three reported any significant effect of CLA. One of the three with reported significance noted that CLA (t11, c9) had no significant effect when given in a low dose, but decreased body fat when the dose was increased.12 Summary. With positive data from only three human studies, there is not enough significant data and/or repeatable studies performed to draw a final and substantive conclusion of the efficacy of CLA for weight or fat loss.  

Green coffee bean extract. Claim: Weight loss. Active ingredients: Unroasted coffee beans, chlorogenic acid, caffeine. Clinical results: A review of studies assessing the efficacy of green coffee extract (GCE) found that, while there was mild success in several studies (insignificant p-value), there was not enough evidence to substantiate any weight loss claims and that more rigorous trials are needed to assess the usefulness of green coffee extract as a weight loss tool.13 Out of 14 published studies, only seven were on humans, and the data was found to be inconclusive. Summary. Prior to promoting the usage of green coffee bean extract for weight loss, studies on patients with a body mass index (BMI) greater than
40kg/m2 should be conducted and should account for individual variations in the physiological response (such as caffeine sensitivity) to natural components present in green coffee.13

Green tea extract. Claim: Increased fat oxidation, stimulation of adipose tissue thermogenesis. Active ingredient: Made from the Camellia sinensis plant. Epigallocatechin-3-gallate (EGCG), caffeine. Clinical results: In a study published in the International Journal of Food Sciences and Nutrition, researchers found that there was no promotion of weight loss in women with Class 3 obesity after eight weeks of green tea extract (ECGC) supplementation.14 Another study, published in the British Journal of Nutrition, examined the effects of ECGC on 83 women with obesity and found no significant difference in the changes in body weight (–0.3kg, 95% CI –5.0, 4.3).15 Summary: There have not been enough studies to prove a significant effect of green tea extract on weight loss. Studies will need to have higher enrollment rates and subject diversity.

Apple cider vinegar. Claim: Glycemic control, weight loss. Active ingredient: Acetic acid Clinical results: The final verdict on this supplement has yet to come in. A significant portion of current research focuses on animals and has been directed toward acetic acid in general. While the research conducted is promising, it is often coupled with other methods of weight loss (such as consumption of high protein snacks, diet modifications) and, therefore, does not provide enough evidence to substantiate apple cider vinegar specific claims of weight loss in human subjects. Summary: Research suggests apple cider vinegar could have potentially significant positive effects on overall health, though there is not enough evidence to denote it as an effective weight loss supplement. It is advised to seek physician counseling prior to adding vinegar to a daily regimen due to potential side effects, such as hypoglycemia or hypokalemia.16

Cayenne pepper. Claim: Decreases appetite, curbs cravings for sweet and salty snacks, boosts metabolism. Active ingredients: Capsinoids, capsiate (CH-19), capsaicin, cinnamaldehyde. Clinical results:  A study published in the journal Physiology and Behavior sought to evaluate the effects of tolerable doses of red pepper on thermogenesis and appetite. In this dose-dependent study, it was found that “the desire to consume food, fullness, prospective food intake, and thirst were not affected by red pepper intake (1g) when compared to no red pepper intake (placebo) treatments.17 A second study that sought to evaluate the effect of the active ingredients in cayenne pepper (capsaicin, cinnamaldehyde) on fat and carbohydrate oxidation and found that neither treatment (capsaicin, cinnamaldehyde) induced any significant changes to energy expenditure or substrate oxidation when compared to the placebo.18 Summary: Research around capsinoids and cinnamaldehyde is evolving. Over time, and with more research, significant results in regard to weight loss and fat oxidation might be concluded.

Conclusion

When dismissed by their physicians or fed up with insurance company hurdles, patients with obesity might feel that they are left with only the alternatives provided by a Google search. Without expert guidance, distinguishing what is real from what is not can be a daunting task. Research on the efficacy of unregulated, understudied supplements regarding weight loss is generally inconclusive. While we are aware of the success rates based on research of new, FDA-regulated and approved medical weight loss medications, analyses that seek to identify a significant difference in outcome among lifestyle modifications and medical weight management are at a stalemate (inconclusive, generally around weight loss maintenance). What is known for certain is that there is no singular medication, supplement, regimen, or surgery that leads to successful weight loss on its own, and that success varies vastly among patients with obesity. To provide the best care for our patients, clinicians need to stay up to date regarding the available weight loss products and their supporting evidence, inform patients of the dangers associated with taking over-the-counter supplements without physician guidance, encourage patients to speak freely and frankly about weight loss, and promote proper, open health discussions. WIth the successful implementation of these initiatives, patients will be well on their way to approaching weight loss with confidence, empirical evidence, and hopefully, success. 

References

  1. Entertainment Today. Weight loss pill that naturally burns fat gets biggest deal in Shark Tank history. http://sharktank.com-today.net/trimgenix/ Accessed April 26, 2018.
  2. Feloni R, Johnson H. Barbara Corcoran’s favorite ‘Shark Tank’ entrepreneurs share the best advice she’s given them. http://www.businessinsider.com /barbara-corcoran-shark-tank-entrepreneurs-best-lessons-2017. Accessed April 26, 2018.
  3. MarketReserach.com. U.S. weight loss market worth $66 billion. December 20, 2017. https://www.prnewswire.com/news-releases/us-weight-loss-market-worth-66-billion-300573968.html Accessed April 26, 2018.
  4. Still C. A happy and healthy 2018: helping your patients set realistic resolutions for the New Year. Bariatric Times. 2018;15(1): 3–4.
  5. Engle M. Prepared statement of the Federal Trade Commission on protecting consumers from false and deceptive advertising of weight-loss products. June 17, 2014. https://www.ftc.gov/. Accessed April 26, 2018.
  6. Haslam D. Weight management in obesity—past and present. Int J Clin Pract. 2016;70(3):206–217.
  7. Cohen P, Goday A, Swann J. The return of rainbow diet pills. Am J Public Health. 2012;102(9):1676–1686.
  8. Supplementary Factory Inspection Report, 5 March 1943, attached to O Olsen to Chief, New York Station, 16 March 1943, AF 10-762 (Clark & Clark), vol. 1, Files, Food and Drug Administration, Suitland, Maryland.
  9. Trust for Americas Health and Robert Wood Johnson Foundation. Obesity rates and trends overview. Retrieved from: https://stateofobesity.org/obesity-rates-trends-overview/. Accessed January 20, 2018.
  10. Haber SL, Awwad O, Phillips A, et al. Garcinia cambogia for weight loss. Am J Health Syst Pharm. 2018;75(2):17–22.
  11. Toubro S, Larsen TM, Gudmundsen O, Astrup A. One year CLA supplement does not prevent weight or fat loss regain. Int J Obes. 2004;28(Suppl 1):S149–S149.
  12. Whigham L, Watras A, Schoeller D. Efficacy of conjugated linoleic acid for reducing fat mass: a meta-analysis in humans. Am J Clin Nutr. 2007;85(5):1203–1211. 
  13. Samadi M, Mohammadshahi M, Haidari F. Green coffee bean extract as a weight loss supplement. J Nutr Disorders Ther. 2015;5:180. 
  14. Quinhoneiro DCG, Nicoletti CF, Pinhel MAS, et al. Green tea supplementation upregulates uncoupling protein 3 expression in severe obese women adipose tissue but does not promote weight loss. Int J Food Sci Nutr. 2018;Feb 26:1–8.
  15. Mielgo-Ayuso J, Barrenechea L, Alcorta P, et al Effects of dietary supplementation with epigallocatechin-3-gallate on weight loss, energy homeostasis, cardiometabolic risk factors and liver function in obese women: Randomised, double-blind, placebo-controlled clinical trial. Br J Nutr. 2014;111(7):1263–1271. 
  16. Kohn J. Is vinegar an effective treatment for glycemic control or weight loss? J Acad Nutr Diet. 2015;115(7):1188.
  17. Ludy MJ, Mattes RD. The effects of hedonically acceptable red pepper doses on thermogenesis and appetite. Physiol Behav. 2011;102(3-4):251–258. 
  18. Michlig S1 Merlini JM, Beaumont M, et al. Effects of TRP channel agonist ingestion on metabolism and autonomic nervous system in a randomized clinical trial of healthy subjects. Sci Rep. 2016;6:20795.

 

 

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