Moderator Fergus Clydesdale initiated the open discussion by observing that the science of the microbiome is focused mostly on associations between the microbiome and disease, not health, and that most dietary interventions intended to have an impact on host biology via their influence on the microbiome (e.g., probiotics) are being studied for their potential to prevent disease, not promote health. He predicted that unless action is taken, the science will continue in that direction—not that it should not. Clydesdale expressed how impressed he was with the science described over the course of the 2-day workshop. The question is, How can additional studies be designed to yield the kind of information needed to substantiate allowable health claims on food products?

The challenge to studying health end points, as opposed to disease end points, is the lack of funding for conducting research in healthy populations, according to Clydesdale. He noted that the National Institutes of Health (NIH) funds disease research, not health research, and that the food industry does not have the kind of money that the pharmaceutical industry has to fund the large clinical studies that would be needed to substantiate health claims. “We have to come up with better ways,” he said. He suggested that a public-private partnership might be a good place for dialogue and that the NIH Program on Public-Private Partnerships might be a good place to initiate the conversation. Another participant suggested that some of the many European public-private partnerships might serve as models.

The significance of studying the microbiome in healthy populations extends beyond the health (versus disease) claim implications of doing so. Dan Levy commented on the “huge opportunity” being missed to gain a better understanding of the important role that the microbiome plays in nutrition, by focusing so much on disease. He mentioned the important role that microbially produced short-chain fatty acids play in maintaining colon health. Susan Crockett of General Mills pointed to the “amazing things” that the food industry can do to help people meet recommended nutrition guidelines, implying that the same would be true if there were authoritative guidance on maintaining a healthy microbiome. For example, with respect to fiber, cereals have been reformulated “bit by bit over a period of years” to include more fiber-containing whole grains in an effort to help Americans meet the recommended guidelines for fiber intake. George Fahey agreed that Americans are doing better than in the past, but noted that most Americans still fall short of the recommended daily intake for fiber. Fiber-like prebiotics (i.e., oligosaccharides) could help close that gap. He said, “We have a great opportunity here to meet the guidelines, but we are going to have to be strategic about it.” Clydesdale urged the inclusion

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