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 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