Safety and efficacy study of Sugar Free Green in Healthy Normal Overweight and Prediabetic Overweight Patients in Controlled Activity Regime
- Conditions
- Health Condition 1: E663- Overweight
- Registration Number
- CTRI/2019/12/022470
- Lead Sponsor
- Zydus Wellness Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 45
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 ±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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Effect of test product will be measured in terms of change in body weight from baseline <br/ ><br>2. Effect of test product will be measured in terms of change in waist circumference from baselineTimepoint: On Day 30, Day 60 and Day 90
- Secondary Outcome Measures
Name Time Method Effect of test product will be assessed in terms of reduction in HbA1c from baselineTimepoint: On Day 30, Day 60 and Day 90.;Effect of test product will be assessed in terms of reduction in lipid profile along with lipoprotein levels from baselineTimepoint: On Day 30, Day 60 and Day 90;Effect of test product will be assessed in terms of Satiety level of the subjects based on subjectsâ?? feedback from BaselineTimepoint: On Day 30, Day 60 and Day 90;Safety of the test product in terms of adverse events reported by subjects or assessed by Investigator during study.Timepoint: On Day 30, Day 60 and Day 90;Safety of the test product will be assessed in terms of adverse events reported by subjects or assessed by Investigator.Timepoint: On Day 30, Day 60 and Day 90.;To assess the amount of sugar consumption of subjects based on subjective evaluation on baselineTimepoint: On Day 30, Day 60 and Day 90