A Pilot Clinical Study of a Nutraceutical Formulation in Overweight Subjects Dylan Ren University of Wyoming Laramie, WY.

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Presentation transcript:

A Pilot Clinical Study of a Nutraceutical Formulation in Overweight Subjects Dylan Ren University of Wyoming Laramie, WY

Type-2 Diabetes Type 2 diabetes mellitus (T2DM) is growing at epidemic proportions ~350 million people worldwide ~30 million in the U.S. Diabetes is an independent risk factor for cardiovascular disease (CVD) Leading cause of morbidity and mortality in the United States

Type-2 Diabetes and the Obesity Connection In the US about 2/3 rd of the adult population is either overweight or obese Growing epidemic of obesity is one of the reasons for increased prevalence of diabetes Number of children and adolescents with obesity and diabetes is on the rise

Age-Adjusted Prevalence of Obesity and Diagnosed Diabetes Among U.S. Adults Aged 18 Years or older CDC’s Division of Diabetes Translation. National Diabetes Surveillance System available at Diabetes No Data 9.0% 2010 Obesity (BMI ≥30 kg/m 2 ) No Data 26.0% 2010

Insulin Resistance Impaired cellular response to insulin Prediabetic stage Precedes the development of full-blown type 2 diabetes Often is seen during transition from obesity to type-2 diabetes

Diet?

Insulin Resistance Management: Diet (Therapeutic Life Style Modification) Exercise Pharmacotherapy Nutritional supplements

GlyacaCare TM Plus Formulation containing: Cinnamon extract Piperine Pterocarpus marsuipum extract Zinc monomethionine Copper lysinate Chromium polynicotinate Bismaltoxo-vanadium

Objective To determine the efficacy of the formulation to Improve insulin sensitivity and glucose tolerance in overweight adults Reduce oxidative stress and inflammatory markers

Design Randomized, double-blind, placebo- controlled study 12-week intervention Inclusion criteria: Body mass index (BMI) between kg/m 2 Not diabetic, not pregnant, does not have any other chronic disease

Enrolled (n=23) Randomized ( n =20) Excluded (n=3) - Did not meet inclusion criteria (n=2) - Declined to participate (n=1) Placebo (n=10) Subjects who completed the study (n=17) Withdrew due to pregnancy (n=1) Withdrew because of relocation (n=1) Withdrew citing difficulty in swallowing capsules (n= 1) GlycaCare Plus (n=10)

Inflammatory Markers

Molecular Oxygen- A Biradical

Reactive Oxygen Species +1e Water Oxygen +1e Superoxide Anion Singlet Oxygen +1e, H + Hydrogen Peroxide OH Radicals Fenton Reaction Fe 2+ /Fe 3+

Oxidant Damage Lipids: Peroxidation Proteins: Denaturation and crosslinking DNA: strand-breaks, base degradation Genes activation: c-fos, c-jun, NF-  B

Isoprostane-ELISA

Marker of Oxidative Stress

Conclusion Short-term intervention with GlyacaCare…. Did not affect body weight, serum insulin, serum glucose or hemoglobin A1C Showed a tendency to decrease HOMA-IR index, improve glucose disposal Reduced oxidative stress Further studies with a larger n, focussed on insulin-resistant subjects would help ascertain the utility of this formulation

Acknowledgment INBRE for the support Sabinsa Corporation Dr. Derek Smith (DEXA) Dr Timothy Robinson (Boot Strap) Drs. Yinan Hua and Sree Nair