Clinical Study of a Proprietary Formulation of a Nutritional Supplement in Overweight Subjects

Obesity is a growing worldwide epidemic and is an independent risk factor for the development of metabolic syndrome, type 2 diabetes, and cardiovascular disease which are leading causes of morbidity and mortality. GlycaCare™ Plus is a proprietary dietary supplement (Sabinsa Corporation, NJ) comprising of extracts of natural products and trace minerals, with suggestive pre-clinical and clinical evidence for improving diabetic symptoms. The objective of this study was to evaluate the effect of GlycaCare™ Plus to improve insulin sensitivity and glucose tolerance in a pilot, randomized, double-blind, placebo-controlled human study. Overweight or obese subjects (n=21) were randomly assigned to receive either GlycaCare™ Plus Oral (500 mg) or placebo, twice daily, for 90 days. Multiple endpoints including blood pressure, body weight, oral glucose tolerance test (OGT), serum glucose, insulin, lipid profile, dual-energy X-ray absorptiometry, serum markers of inflammation (C-reactive peptide, interleukin-6), and serum oxidative stress (8-isoprostane) were assessed before and after 90-days of treatment. A trend towards reduction (p<0.06) was observed in homeostatic model assessment of insulin resistance (HOMA-IR) and the integrated area under the post-glucose plasma curve following OGT in the subjects receiving GlycaCare™ Plus. No significant changes were observed between the placebo and treatment group body weight, android or gynoid fat distribution, fasting glucose, fasting insulin, hemoglobin A1C and serum inflammatory markers. In contrast, serum 8-iisoprostane levels were significantly lower in subjects who received GlycaCare™ Plus compared to those who received the placebo. These data support future larger clinical trials of GlycaCare™ Plus for the development as a supplement to treat or control obesity and its complications.