Expanding the health halo of whole grains

by Allison Gibeson
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Later this year manu-facturers of whole grain products might be able to begin boasting on package about a health benefit several medical professionals claim they already know — con-sumption of whole grains leads to a reduced risk of type 2 diabetes.

On Feb. 13, ConAgra Foods, Inc., Omaha, Neb., submitted a petition to the U.S. Food and Drug Administration for the authorization of a health claim about the relationship between whole grain consumption and reduced risk of type 2 diabetes. The petition included data from eight prospective observational studies and 20 randomized controlled trials. Overall, the primary data used to support the petition represents five million person years of follow-up and a half-million subjects studied for 6 to 18 years, according to the petition.

“The connection between the public health problem of the growing incidence and health care burden of diabetes and the public health goal of increasing consumption of whole grains are the data generated over the past 15 years demonstrating consumers with diets containing whole grains have a significantly reduced risk of developing type 2 diabetes,” said Mark Andon, Ph.D., vice-president of nutrition in ConAgra Food’s research, quality and innovation division.

Overall, Dr. Andon said the research shows on average those that consume a diet rich in whole grains, about three servings a day, are 25% less likely to develop type 2 diabetes. He said exactly how whole grains reduce the risk of diabetes isn’t clear, but that isn’t surprising given the many attributes of whole grains.

“There is most likely not one single mechanism through which (whole grains) are acting,” Dr. Andon said. “There are probably multiple vectors.”

He said not knowing the mechanism has no bearing on the health claim, and there are many established health claims where the mechanism is unknown.

Difficult to isolate mechanism
Cynthia Harriman, director of food and nutrition strategies for The Whole Grains Council/Oldways, also said there are many interactions between different foods and lifestyle factors that make it difficult to isolate one variable and positively identify it as the acting mechanism.

ConAgra provided two proposed model health claims consistent with the data presented in the petition:
• “Scientific evidence suggests, but does not prove, that diets low in saturated fat and cholesterol that include three servings (48 grams) of whole grains per day may reduce the risk of diabetes mellitus type 2.”
• “Scientific evidence suggests, but does not prove, that whole grains (three servings or 48 grams per day), as part of a low saturated fat, low cholesterol diet, may reduce the risk of diabetes mellitus type 2.”
The funding of the studies came from the National Institutes of Health, and research groups that conducted most of the research came from Harvard University, the University of Minnesota, Brigham and Women’s Hospital in Boston, and the University of Amsterdam in The Netherlands.

Impacts on the industry
While the industry has long known of the connection between whole grains and reduced risk of type 2 diabetes, food companies have been unable to mention the benefit.

“Consumers are receiving this health message — that amongst the other benefits of consuming more of your grains as whole grains it can also reduce your risk for diabetes — and they are receiving that from really credible health organizations,” Dr. Andon said. “Without this health claim, they are not able to receive that same consistent message when they look at a food package or when they receive information from a food company.”

As a result, Dr. Andon said there is a chasm between the information consumers receive from health professionals and what they see at the grocery store. He said if the claim is approved it will synergize the current public education efforts as the message will be reinforced at the grocery store.

Ms. Harriman also said medical organizations always tell patients in diabetes counseling to eat more whole grains than refined grains, and it’s the food companies that are currently being left out from communicating the benefit. She also said the health claim may have an impact on the industry as it resonates with many consumers on a deeper level than the other whole grains health benefits, such as heart health.

“Because of the rapid rise in diabetes … it seems like a more imminent threat to a lot of people, so they might pay more attention to a health claim that ties whole grains to diabetes,” Ms. Harriman said.
Other established health claims for whole grains include one related to the reduced risk of heart disease and one related to the reduced risk of heart disease and certain cancers. Ms. Harriman said one drawback to the current heart health claim for whole grains is it is based on 51% of the total weight of the product being whole grain, which makes it difficult for moisture-heavy foods like bread to qualify. Yet in the diabetes health claim, ConAgra is requesting the level be set at 12 grams of whole grains per reference amount customarily consumed, which makes it easier for bread to qualify.

The petition for the claim is available at www.regulations.gov and is open to comments until May 11. The F.D.A. is scheduled to respond by Oct. 23.

In terms of additional whole grain health claims, Ms. Harriman said there is a possibility of health claims related to specific types of digestive cancers to be introduced in the future. She said the National Institutes of Health has been conducting research into a possible link between whole grains and colorectal cancer.
According to Mintel’s Global New Products Database, there were 808 products introduced in 2011 with whole grain claims, down from 930 in 2010 but up from 612 in 2009. Some of the more recently introduced products include Goldfish Soft Honey Whole Wheat sandwich bread from Pepperidge Farm and Sweet Cinnamon Wheat Thins from Nabisco.
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