A randomized, double-blind, placebo-controlled, parallel-group, clinical study to evaluate the thermogenic effect of AfperFit on body fat loss in overweight subjects.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- 1.Changes in whole body energy expenditure from baseline to end of the study
研究概览
简要总结
Thisis a double blind, randomized (1:1), placebo controlled, parallel group, twoarm study. Overweight subjects meeting all inclusion and no exclusion criteria,after signing a written informed consent will be enrolled in the study. Afterpassing the eligibility criteria, subjects will be randomized into 2 treatmentarms (50:50) to receive either AfperFit or placebo. Subjects will be requestedto adhere with their routine diet and exercise regimen throughout the study.
Thesubject will arrive at the study site in a fasted state and blood samples willbe collected for laboratory assessment .
Postblood sample collection, energy expenditure ,body composition and fat distribution will be assessed Anthropometric measurements recording(height, weight, BMI, waist circumference, waist to hip ratio) will berecorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •1Male and Female Subjects 2Overweight Subject: BMI ≥ 25.0 to < 30.0 kg/m2 3Subject willing to adhere with their routine diet and exercise regimen throughout the study.
- •4Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1Subjects suffering from any chronic health conditions (e.g. diabetes, hypertension, chronic renal failure, heart and liver disease) 2Subjects with fasting blood sugar above the normal limits during screening 3History of Chronic metabolic disease Psychiatric illness Drug abuse, smoking, abuse/addiction to alcohol Eating disorder such as bulimia or binge eating Endocrine abnormalities including stable thyroid disease History of any major surgery, including cardiovascular surgery and bariatric surgery 4History of allergic reaction to contrast dye, herbal products or any component of the study product 5Subjects on other therapies such as Homeopathy / Ayurveda 6Subjects with positive HIV card test during screening 7Known Hepatitis B positive or any other immuno-compromised state 8Diagnosis of any other clinically significant medical condition which in opinion of investigator may jeopardize subject’s safety and preclude trial participation 9Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study 10Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
1.Changes in whole body energy expenditure from baseline to end of the study
时间窗: Day 0, Day 84
2.Change in body composition and fat distribution from baseline to end of the study
时间窗: Day 0, Day 84
次要结局
- Changes in body weight from baseline to end of the study(Day o, Day 42, Day 84)
- Changes in BMI from baseline to end of the study(Day 0, Day 42. Day 84)
- Changes in Questionnaire based assessments(Day 0, Day 42, Day 84)