CTRI/2019/12/022470已完成不适用
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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Effect of test product will be measured in terms of change in body weight from baseline
研究概览
简要总结
Thestudy would involve consumption of Sugar Free Green, by Normal HealthyOverweight subjects and Pre-Diabetic Overweight patients, to evaluate the meanchange in the body weight and waist circumference by blood sample collection andsubjective perception before and after test product consumption. Safety of the testproducts will be assessed throughout the study duration in terms of adverseevents reported by subject or assessed by Investigator during study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 55.00 Year(s)（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
1. Effect of test product will be measured in terms of change in body weight from baseline
时间窗: On Day 30, Day 60 and Day 90
2. Effect of test product will be measured in terms of change in waist circumference from baseline
时间窗: On Day 30, Day 60 and Day 90
次要结局
- Effect of test product will be assessed in terms of reduction in HbA1c from baseline(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.(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.(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 baseline(On Day 30, Day 60 and Day 90)
- To assess the amount of sugar consumption of subjects based on subjective evaluation on baseline(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 subjects’ feedback from Baseline(On Day 30, Day 60 and Day 90)
研究者
研究点 (1)
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