It's Time to Mow the GRAS in Type 1 Diabetes
Tommy (fictitious name, but a true story) did not pick a run-of-the-mill school science fair project, such as seeing whether plants grew better with Bach versus Metallica, powering a radio with a potato, or testing the absorbency of various paper towel brands. Tommy, one of our patients with type 1 diabetes, had a different motivation. His project was designed to test whether a simple dietary modification, the addition of ground grapefruit rind, would improve postprandial glucose values. This was not a randomized controlled trial with statistical power; indeed, his mother served as the data safety monitoring board, institutional review board, and the Food and Drug Administration equivalent granting regulatory approval. Yet, even with the N = 1, the results were eye-opening. His simple experiment demonstrated improved diabetes management.
This observation some 3 years ago, combined with many other like reports over the years, has convinced us that it is time to readdress this issue of large-scale clinical testing for Generally Recognized As Safe (GRAS)-like agents in settings of type 1 diabetes. Evaluating the ability of these agents to enhance glycemic control, and/or improve anti-inflammatory/antioxidant/immunomoregulatory status, could identify a safe and cost-effective approach to improving lives and perhaps attenuate disease-associated complications. GRAS-like agents refers to agents covered under the Food and Drug Administration's GRAS and dietary supplement (i.e., the Dietary Supplement Health and Education Act) regulations and, in a few cases, other constituents such as probiotics and helminthes.
This was not a new idea for us, for those in the clinical research and practice communities, or for patients with type 1 diabetes. Indeed, many GRAS-like agents have been tested in type 1 diabetic patients in situations ranging from those anecdotal in design to efforts involving controlled clinical trials. Examples include coenzyme Q10, garlic, magnesium, and chromium (rev. in 1). With a …