A Randomized, Prospective, Double Blind, Placebo Controlled Study to Evaluate Efficacy and Safety of Nutricharge® S F on Weight Maintenance in Obese Subjects
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- –The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3 (Phase 5) of treatment.
研究概览
简要总结
This study is a randomized, prospective, double blind, placebo controlled study to evaluate efficacy and safety of Nutricharge® S&F on weight maintenance in obese subjects daily for 12 weeks in 100 patients with Obese that will be conducted in two centers in India. The primary outcome measures will be The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3(Phase 5) of treatment. The secondary outcomes will be Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug.The change in Quality of Life from will be identified in general feedback.
Nutricharge S F Product Composition.
| Energy |
136.2 kcal
|Protein
15 g
|Carbohydrates
15 g
|Sugar
0.00 g
|Dietary fiber
6 g
|Fat
1.8 g
|Garcinia cambogia Extract
1 g
|Conjugated Linoleic Acid (CLA)
500 mg
|Green coffee bean extract
400 mg
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and female subjects aged between 18 and 65 Years.
- •2.BMI ≥ 30 and ≤ 47 3.Subjects able to communicate effectively.
- •4.In the judgment of the Principal Investigator, able to comply with protocol requirements.
排除标准
- •1.Contraindications or Hypersensitivity to study product or placebo.
- •2.History or presence of any medical condition or disease according to the discretion of the Investigator.
- •3.Clinically relevant conditions expected to preclude achievement of exercise recommendation.
- •4.Current use of vitamin or mineral supplements, nutritional supplements and or medical foods within 30 days prior to the beginning of the study and for the duration of the study.
- •5.Use of prescription medications and/or nonprescription medications for acute medical conditions, semi-acute medical conditions, and weight loss.
- •6.Use of medications known to result in significant weight gain (e.g., oral steroids or second generation anti-psychotics) 7.Hepatic, renal, gastrointestinal, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease.
- •8.Diabetes mellitus, irritable bowel syndrome, Gastro-esophageal reflux disease, HIV, hepatitis B or C, malignancy, sleep apnea, insomnia (requiring use of sleeping medication more than once weekly), night eating syndrome, Anorexia nervosa, bulimia, of non-specific eating disorder, and serious psychiatric illness 9.Female subjects who are currently pregnant and breast feeding 10.Current diagnosis or history of alcoholism or drug dependence.
- •11.Currently taking any medication on a regular basis.
- •12.Use of any experimental medication within 1 month prior to screening or as concomitant medications.
结局指标
主要结局
–The change in the anthropometric measurements (Body Mass Index (BMI), body fat analysis and waist circumference) from baseline visit (Phase 2) to after Day 90 ± 3 (Phase 5) of treatment.
时间窗: Day 15,30,60 and 90.
次要结局
- –Safety will be assessed from the number of adverse events occurred and judging their causal relationship to the study drug.(–The change in Quality of Life from will be identified in general feedback)