Life Sciences Research Office, Inc. (LSRO) conducted an independent review of the scientific literature to evaluate the effect of applying the U.S. Food and Drug Administration (FDA) definition of whole grains on the strength of scientific evidence in support of whole-grains health claims for risk reduction of cardiovascular disease (CVD) and diabetes.
This report was sponsored by the Kellogg Company.
LSRO followed the specifications of the FDA guidelines for eligible studies to establish a health claim. The scope of the review was limited to human intervention and observational studies that measured a validated endpoint or a surrogate endpoint for CVD and/or diabetes in a healthy US population or a population representative of the US. The evaluation of the relationship between whole grain intake and CVD and whole grain intake and diabetes was conducted in two steps. First, LSRO analyzed only studies that explicitly described or defined whole grains according to the FDA definition of whole grains. In that context, we concluded that there was insufficient scientific evidence to support a risk health claim for whole grain intake and CVD or whole grain intake and diabetes. Later, LSRO expanded the analysis to include studies with a broader definition of whole grains (i.e. whole grains plus supplementary bran, germ, or fiber). We concluded that using a broader concept of whole grain, a whole grain and CVD health claim is supported. The scientific evidence on the relationship of whole grain consumption and diabetes is suggestive but inconclusive whether or not the definition of whole grains was in accordance with that of the FDA. This report was undertaken in consultation with an independent Expert Panel composed of scientific experts in the fields of cereal chemistry, nutrition, epidemiology, and food regulation. The report was reviewed and approved by the LSRO Board of Directors.
The report, "Whole Grain Intake and Cardiovascular Disease and Whole Grain Intake and Diabetes: A Review" is available to the public for purchase through the LSRO online bookstore.