Pilot Clinical Study of a Proprietary Formulation GlycaCareTMPlus inOverweight Subjects
Sreejayan Nair1, Yinan Hua1, Jun Ren1, Tyler P. Rasmussen2, Derek Smith2, Rama P. Nair4, Timothy J Robinson3, Majeed Muhammed5, Kalyanam Nagabhushanam5
Â 1Division of Pharmaceutical Sciences & Center for Cardiovascular Research and Alternative Medicine,2Division of Kinesiology and Health, College of Health Sciences, University of Wyoming, Laramie, WY 82072, USA, 3WWAMI Medical Education, College of Health Sciences, College of Health Sciences, University of Wyoming, Laramie, WY 82072, USA, 4Nutriwyo LLC, Wyoming Technology Business Center, 1938 Harney St, Laramie, WY 82072, USA, 5Sabinsa Corporation, 20 Lake Drive, East Windsor, NJ 08520
Background and objective: Obesity is a growing epidemic worldwide and is a major public health threat and is an independent risk factor for the development of metabolic syndrome, type 2 diabetes, and cardiovascular diseases which are leading causes of morbidity and mortality in developed countries. The objective of this study was to evaluate the effect of a proprietary dietary formulation GlycaCareTMPlus to improve insulin sensitivity and glucose tolerance in overweight adults. Methods: Oral dose of 500mg or placebo were administered, twice daily for days of overweight subjects (n=21). Multiple pharmacodynamic endpoints including blood pressure, body weight, oral glucose tolerance test (OGT), serum lipid profiles, Dual-energy X-ray absorptiometry for assessment of body fat distribution, markers of inflammation (C-reactive peptide, interleukin-6), and extent of oxidative stress (8-isoprostane) were assessed. Results: No significant changes were observed between the placebo or treatment group in the body weight, fat distribution, fasting glucose, fasting insulin or hemoglobin A1C. A trend towards reduction was seen in HOMA-IR and the integrated area under the post glucose plasma curve following OGT was observed in the treatment group. While not significant differences were seen in serum inflammatory markers, a significant reduction was observed in serum 8-isoprostane levels in the subjects who received the treatment. Conclusion: This pilot study suggests that GlycaCareTMPlus improves glucose intolerance and attenuates oxidative stress in overweight subjects. These data support future larger clinical trials of GlycaCareTMPlus for the development as a supplement to treat or control obesity and its complications.