Weight Loss Adjuncts

Recent weight loss study reveals a potential new direction for dietary supplements.

By Douglas Kalman, PhD, MS, RD, CCRC, FACN

Have you ever read an advertisement for a product and wondered, “How can they say that?” This is a common reaction among consumers across all market channels. The way to avoid this reaction is to grow the science behind your products. With all things being equal, this one aspect will result in better regulatory compliance and market acceptance.

There are multiple ways to use science to grow your brand. These include: product specific studies, third-party studies (can be ingredient studies), monographs, government or NGO (non-governmental organization) white papers or reviews from scientific non-profit organizations as well as agencies within the offices of FDA and CFSAN .

If You’ve Got It, Flaunt It

If you had a finished product or a branded ingredient backed by intellectual property (IP) protection and peer-reviewed published studies (smartly associated with well-drafted patents), would you advertise it? If you did advertise that your product—whether finished commodity or branded ingredient—was supported by science, would you let your customer, no matter who it is, know how to view, read, download and obtain the “proof” of your IP claims?

Some advertisements in journals today depict trademarked products accompanied by statements such as “This product has had more than ‘XX’ clinical trials with ‘YY’ safety studies alone…confirming its safe use…” Partner this with a statement that might possibly run afoul of the FTC “Guide for Advertising Dietary Supplements” and the FTC “Workshop on Weight Loss Claims” and a real conundrum AND opportunity arises. In this case, a statement that could trigger a red flag includes: “It absorbs [insert carbohydrates or fats] and thus the calories are flushed out of the system.”

Let’s discuss the possible opportunities here. If you did truthfully have more than XX studies (which denotes more than 10) on your specific product and an additional YY safety studies (YY again denotes at least 10), then why not let the world see? Within your communications you could provide the public with a web link to those studies and note the classifications of them, so that the reader could easily determine the level of substantiation. Referring people to an informational website could also serve as your public Product Master File/Dossier containing your support for the product. Doing this also publicly informs your competitors that you have IP to defend your product. Lastly, as long as you maintain this research database—or contract with a firm to maintain the database—in a timely fashion and fair and balanced way, referring people to this information via the web could help you stay compliant in the eyes of authorities. At the end of the day the result is increased customer confidence, whether the customer is a supplement company that sells finished products or the end consumer.

The downside is if the same company claims to have all of this IP and substantiation, but does not make it easy for anyone to view it. It goes without saying that this kind of behavior breeds skepticism both about the company as well as its products.

Results of a ‘Game Changing’ Weight Loss Study Revealed

Recently, the compound N-oleyl-phosphatidylethanolamine (“NOPE”), along with the green tea component EGCG (epigallocetchin gallate) was found to be effective as a weight loss adjunct. The study evaluating this combination—Phospholean—looked at 138 overweight and obese men and women who all received a reduced-calorie diet (800-1000 calories less than normal intake), with a registered dietitian enforcing the diet program. All study participants kept their exercise routines the same, but about half of the study participants were given Phospholean, while the others received a placebo. The study duration was eight weeks.

What makes this study one that might be “game changing” for the weight loss market is that instead of examining whether or not Phospholean was effective on its own, researchers examined it for its ability to assist with compliance on the diet. In other words, the goal for the product was for it to perform better than placebo in helping people stick to their World Health Organization (WHO) designed diet.

Usually when a person diets they re­strict themselves in some way from foods, beverages or other items that are perceived to affect body weight. Restricted eating over time may lead to psychological distress. This distress makes staying on the weight loss plan harder, therefore a weight loss adjunct that decreases the psychological stresses of dieting or weight loss, while not interfering with weight loss, may be the solution.

In the end, Phospholean tested better than placebo in terms of helping people stick to their prescribed diet. Further, the weight loss was at least 33% more robust according to raw numbers between those on the test product and those on placebo. Subjects taking Phospholean also experienced improved insulin sensitivity, lower binge scores, less depressive symptoms, and increased satiety. As a result, those taking Phospholean had an easier dieting experience compared to the placebo group.

There are many opportunities here for Phospholean, including partnering with well-known, successful weight loss plans to make the dieting experience feel easier. Weight loss adjuncts certainly have a place as a psychological aid in supporting weight loss and this new category deserves further exploration.

Why Hide the Science?

If you have the science to support your product, why hide it? The judicious use of modern technology to communicate your substantiation can only help build confidence in your product. Expertly coordinated communication will also help extend your product lifecycle. Lastly, consider the Phospholean study as an example of a product de­signed to help a diet work rather than being the sole driver for weight loss. This approach opens a whole new category for dietary supplements.NW

References furnished upon request.