Two authors of a 2012 paper sponsored by a company that made grand claims about green coffee bean extract’s abilities to help people lose weight have retracted it. The study was cited by The Dr. Oz Show, and last month it cost the company a $3.5 million settlement with the Feds.
Here’s the notice for “Randomized, double-blind, placebo-controlled, linear dose, crossover study to evaluate the efficacy and safety of a green coffee bean extract in overweight subjects,” a paper originally published in Diabetes, Metabolic Syndrome and Obesity: Targets and Therapy:
The sponsors of the study cannot assure the validity of the data so we, Joe Vinson and Bryan Burnham, are retracting the paper.
The Federal Trade Commission (FTC) explained in a September press release about the settlement that:
The FTC complaint alleges the study was so hopelessly flawed that no reliable conclusions could be drawn from it. The flawed study, which purported to show that the product causes “substantial weight and fat loss,” was later touted on The Dr. Oz Show.
The FTC’s settlement with Applied Food Sciences, Inc. (AFS), which sells a green coffee ingredient used in dietary supplements and foods, requires the company to pay $3.5 million, and to have scientific substantiation for any future weight-loss claims it makes, including at least two adequate and well-controlled human clinical tests.
“Applied Food Sciences knew or should have known that this botched study didn’t prove anything,” said Jessica Rich, Director of the FTC’s Bureau of Consumer Protection. “In publicizing the results, it helped fuel the green coffee phenomenon.”
Here’s what the FTC said about the study:
According to the FTC’s complaint, in 2010, Austin, Texas-based AFS paid researchers in India to conduct a clinical trial on overweight adults to test whether Green Coffee Antioxidant (GCA), a dietary supplement containing green coffee extract, reduced body weight and body fat.
The FTC charges that the study’s lead investigator repeatedly altered the weights and other key measurements of the subjects, changed the length of the trial, and misstated which subjects were taking the placebo or GCA during the trial. When the lead investigator was unable to get the study published, the FTC says that AFS hired researchers Joe Vinson and Bryan Burnham at the University of Scranton to rewrite it. Despite receiving conflicting data, Vinson, Burnham, and AFS never verified the authenticity of the information used in the study, according to the complaint.
As the FTC explains:
Despite the study’s flaws, AFS used it to falsely claim that GCA caused consumers to lose 17.7 pounds, 10.5 percent of body weight, and 16 percent of body fat with or without diet and exercise, in 22 weeks, the complaint alleges.
Although AFS played no part in featuring its study on The Dr. Oz Show, it took advantage of the publicity afterwards by issuing a press release highlighting the show. The release claimed that study subjects lost weight “without diet or exercise,” even though subjects in the study were instructed to restrict their diet and increase their exercise, the FTC contends.
Scott Gavura critiqued the study for Science-Based Medicine in 2012.
Please see an update on this post.