The public-private partnership study, first announced last year, was highlighted in a presentation given by principal researcher Dr JoAnn Manson MD at the Future of Food Summit on Wednesday held in Washington, DC. Manson spoke with NutraIngredients-USA after the presentation to give a picture of the study design and what the researchers hope to accomplish.
The study is a collaboration of Brigham and Women’s Hospital, the Harvard Medical School and Mars Inc., which is providing infrastructure help including the test material. The study, which also includes the National Institutes of Health and the Fred Hutchinson Cancer Research Center in Seattle, will recruit 12,000 women ages 60 and up and 6,000 men 65 and up. It will follow this cohort for four years of treatment and five years overall said Manson, who is the chief of the division of Preventive Medicine at BWH. The promising results of earlier trials provided a basis for concluding a bigger trial was called for, she said.
“There have been some previous randomized trials that have been smaller and mechanistic in nature,” Manson said. “They looked at things like cholesterol levels, lipid levels, blood glucose and insulin resistance. Those are some of the key pathways that have been implicated in heart disease and stroke.”
“They have been favorable. Now we are going to looking at clinical events and whether cocoa flavanols lessen the risk of cardiovascular events,” she said. “We hope we can translate those earlier favorable results to a reduced risk in heart disease and stroke but you never know. Sometimes mechanistic studies don’t translate that way.”
Manson said there have also been smaller, mechanistic studies looking at cocoa flavanols’ relation to cognitive function. An earlier Mars study found that high cocoa flavanol consumption may help improve cognitive function, possibly though changes in insulin sensitivity. The upcoming large-scale study will look at these effects, too, including memory, decision-making skills, mood, and cognitive performance, Manson said, but won’t include the full cohort.
Supplement, not a health food
The new study will use a 600 mg daily dose, divided between two capsules. As to how this might translate into marketplace recommendations in the future, Manson said she believes the future of cocoa flavanols is squarely in the supplement realm, whether as a powdered add on for yogurt or other foods or in a straight pill form. Chocolate is a confection, and not all processing schemes preserve the flavanol content, she said. (Both Mars and Barry Callebaut tout processing methods that do.) Even with raw material that still contains the native flavanol content, a consumer would have to eat 5,000 calories or more worth of chocolate a day to get an effective dose, she said.
The study is designed also to test multivitamins which will be provided by Pfizer, Manson said, so it will be organized in a 2x2 fashion with one group receiving both the flavanols and the vitamins, others receiving one agent and a placebo and the fourth group getting a double placebo.
Manson said the organization work is almost complete and large-scale mailings will be sent out by the end of May. Results from the trial are expected some time after 2020.