Weight-Loss ‘Study’ Was Bogus, FTC Claims

AUSTIN, Texas (CN) - Applied Food Sciences sponsored a flawed 2010 human clinical trial in Bangalore, India, and then made unsubstantiated weight-loss claims about its Green Coffee Antioxidant diet supplement, the Federal Trade Commission claims in court.

After conducting its so-called double blind trial, AFS touted its results through a "white paper," posters, press releases and speeches.

However, the FTC says: "(T)he principal investigator repeatedly: (1) altered the weights and other key measurements of the subjects; (2) changed the length of the trial; and (3) confused which subjects took either the placebo or GCA [Green Coffee Antioxidant] at various points during the trial. When the principal investigator failed to find a publisher for his summary of the purported trial, AFS hired ghost-writers, who - like AFS - themselves received numerous, conflicting data sets from the principal investigator, but accepted the final version as correct. The published study does not refer to these inconsistencies. Moreover, the published study fails to explain why most of the reported weight loss occurred when subjects were taking neither GCA nor a placebo; and fails to disclose that subjects were exercising and/or dieting during portions of the trial."

The study was based on flawed clinical trial conducted by Dr. Mysore Nagendran, who was with the Trinity Hospital and Heart Foundation in Bangalore, according to the lawsuit.

When Nagendran could not find a publisher for the draft manuscript of the Bangalore trial, AFS gave the draft to Professors Joe A. Vinson and Bryan Burnham of the University of Scranton for revision and to submit it for publication, the FTC says. Vinson and Burnham saw multiple discrepancies in the data and asked Nagendran about these discrepancies. Nagendran replied by giving the professors new data sets to correct the errors.

"Despite these discrepancies, Vinson, Burnham, and AFS did not check the revised data sets against the raw data, which they never reviewed. Rather, Vinson, Burnham, and AFS relied solely on Nagendran's assurance that the data set provided on August 5, 2011, was accurate," the complaint states.

The FTC says it found other problem with the report.

"First, the study indicates that the sixteen subjects, on average, lost 17.7 pounds total, but lost the majority of that weight - 10.5 pounds - during the two, two-week washout periods when the subjects were taking nothing. ... (S)ubjects lost more weight, and at a faster rate, during the two washout periods in which subjects were not taking anything than when they were taking GCA or a placebo.

"Second ... the six subjects who purportedly began the trial on the placebo experienced a precipitous weight loss during the two-week washout period after they stopped taking the placebo and before they began their first GCA arm. The study's supporting data indicates that these persons, who at that point had never taken GCA, lost, on average, 11.9 pounds during these two weeks. Weight loss of that magnitude over that time period without changing diet is extremely unusual, if not impossible, and undermines the reliability of all of the study data."

Finally, the FTC claims: "Separate from these anomalies, the published study fails to disclose that the protocol provided for subjects to undergo daily, 400-calorie workouts during the first two arms of the trial, when most of the reported weight loss occurred, and to restrict their caloric intake during the second arm. ...

"(T)he study either was never conducted or suffers from flaws so severe that no competent and reliable conclusions can be drawn from it."

The FTC seeks an injunction, rescission or reformation of contracts, restitution, refunds, disgorgement of ill-gotten funds, and penalties for violations of the FTC Act, injury to consumers and unjust enrichment.

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