New multicenter trial confirms: breakthrough medical food helps reduce risks for diabetes and heart disease

One in three US adults meet diagnostic criteria for metabolic syndrome (MetS), placing them at greater risk of developing type 2 diabetes, cardiovascular disease (CVD), and other chronic illnesses. MetS is a cluster of conditions that typically includes at least three of the following: elevated triglycerides (TG), low HDL cholesterol (HDL-C) elevated waist circumference (WC), elevated blood pressure (BP), and/or elevated fasting glucose. Additionally, those with metabolic syndrome and elevated LDL cholesterol (LDL-C)—the primary target for lipid-lowering therapies—have been identified as a higher risk group.

Previous clinical studies conducted by the Functional Medicine Research CenterSM, the clinical research arm of Metagenics, Inc., have shown that a 12-week lifestyle intervention program consisting of a modified, Mediterranean style diet with a low glycemic load and regular aerobic exercise can be enhanced with the addition of a targeted medical food to manage conditions associated with MetS.1,2 In one head-to-head comparison of the 12-week modified Mediterranean diet and exercise program in subjects with MetS and elevated LDL-C, 43% of the subjects consuming the ingredients of UltraMeal Plus 360° medical food showed a resolution of MetS compared to only 22% of the subjects on the diet and exercise alone.2

To confirm these results, a 12-week, 2-arm randomized trial was conducted at three universities (University of Connecticut-Storrs, University of Florida-Jacksonville, University of California-Irvine) and consisted of 89 women (ages 20 to 75) with elevated LDL-C, elevated TG, and two of the four remaining criteria for MetS. Those with heart, liver, or kidney disease or taking cholesterol- or blood sugar-lowering agents were excluded. Those with type 2 diabetes were not excluded. Both arms followed a modified Mediterranean diet while maintaining normal exercise levels; the medical food arm consumed two servings of UltraMeal Plus 360° daily.

Both groups saw similar, significant decreases in WC, BP, and TG (p<0.001 for all). However, the UltraMeal Plus 360° arm showed up to two times greater effect in reducing key CVD risk measures, such as significantly greater reductions in LDL-C, non-HDL-C, and apolipoprotein (apo) measures (apo B and apo B/apo A1) vs. control (p<0.05 for all). The medical food group also showed significantly reduced plasma homocysteine (p<0.01), while control subjects demonstrated an increase. Likewise, 44.4% of the UltraMeal Plus 360° subjects showed a resolution of metabolic syndrome vs. 31.8% of the control subjects.3“Patients who incorporate the medical food along with lifestyle therapy get healthier quickly and safely,” said Robert H. Lerman, MD, PhD, director of medicine and extramural clinical research for Metagenics, Inc.“It’s very important for physicians to learn about these new findings. Doctors have not been trained to take a therapeutic lifestyle approach with patients who have metabolic syndrome,” said Mark S. McIntosh, MD, one of the principal researchers who is the Director of Corporate Wellness and Assistant Professor in the Department of Emergency Medicine at the University of Florida-Jacksonville.“Most physicians are accustomed to prescribing drugs for people with lifestyle-related conditions, even though the first line recommended course of treatment is lifestyle therapy,” said Dr. Wayne Dysinger, current president of the American College of Lifestyle Medicine and chair of the Department of Preventive Medicine at Loma Linda University in Loma Linda, California. “This study reminds physicians that the option of prescribing food, in this case a medical food, should be considered. It demonstrates the ability of medical foods to help reduce risk factors and improve health.”1. Lerman RH, Minich DM, Darland G, et al. Enhancement of a modified Mediterranean-style, low glycemic load diet with specific phytochemicals improves cardiometabolic risk factors in subjects with metabolic syndrome and hypercholesterolemia in a randomized trial. Nutr Metab (Lond). 2008;5:29.
2. Lerman RH, Minich DM, Darland G, et al. Subjects with elevated LDL cholesterol and metabolic syndrome benefit from supplementation with soy protein, phytosterols, hops rho iso-alpha acids, and Acacia nilotica proanthocyanidins. J Clin Lipidol. 2010; 4(1)59-68.
3. Jones JL, Fernandez ML, McIntosh MS, et al. A Mediterranean-style low-glycemic-load diet improves variables of metabolic syndrome in women, and addition of a phytochemical-rich medical food enhances benefits on lipoprotein metabolism. J Clin Lipidol. 2011 [pending publication]
Article appears in the May/June 2011 issue of the Journal of Clinical Lipidology. Abstract and pre-press article at: www.lipidjournal.com/article/S1933-2874(11)00082-1/abstract