An Open-Label, Single-Arm Study to Evaluate the Safety and Efficacy of Sugar Free Green in Healthy Normal Sugar Level Overweight and Pre-diabetic Overweight Adult Human Subjects in Controlled Physical Activity Regimen

Zydus Wellness Limited0 个研究点目标入组 45 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1) Age: 18 to 55 yrs
•2) Sex: Male and/or non-pregnant/ non-lactating females
•3) Body Mass Index (BMI) of >=25 to <= 30.0 kg/m2
•4) For Pre-diabetics subjects: Fasting Blood Glucose level from 100-125 mg/dL (called impaired fasting glucose or IFG) and HbA1c levels >=5.7% to <=6.4%
•5) Subjects willing to follow diet plan
•6) Subjects willing to reduce their weight and waist circumference
•7) Subjects with history of stable weight, defined as no significant weight change (less than Â±5%) within 03 months prior to enrollment and the physical activity level lesser than 2.0
•8) Normal renal and liver tests
•9) Subject must be willing to abstain to eat any other sugar containing products, any other form of sugar usage for the duration of the study

•1) Pregnant female subjects or females planning to get pregnant during study duration
•2) Subjects having Type 1/ Type 2 Diabetes Mellitus
•3) Subjects having Insulin Resistance
•4) Subjects having Lipid Abnormalities
•5) Subject diagnosed with eating disorders such as bulimia or binge eating
•6) History of Positive HIV test
•7) History of Hepatitis B Virus
•8) Subject with any history of drug and alcohol abuse
•9) History of Cancer
•10) History of clinically significant cardiac disease or endocrine abnormalities

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