Presenter Information

Dylan Y. Ren, University of Wyoming

Department

School of Pharmacy

First Advisor

Dr. Sreejayan Nair

Description

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. GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM Plus compared to those who received the placebo. These data support future larger clinical trials of GlycaCareTM Plus for the development as a supplement to treat or control obesity and its complications.

Comments

Oral Presentation, INBRE

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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. GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM 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 GlycaCareTM Plus compared to those who received the placebo. These data support future larger clinical trials of GlycaCareTM Plus for the development as a supplement to treat or control obesity and its complications.