NCT02144636已完成不适用
Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- weight loss
研究概览
简要总结
This randomized control trial of diet with protein supplementation is being conducted to test the hypothesis that in overweight/obese subjects high protein diet may lead to weight loss and improvement in cardio-metabolic profile.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 65 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects aged between 21 -65 years
- •Subjects with BMI > 23 Kg/m2
排除标准
- •Inclusion Criteria:
- •Subjects aged between 21 -65 years
- •Subjects with BMI > 23 Kg/m2
- •Exclusion Criteria:
- •Diabetes (type 1 and type 2)
- •Known or documented coronary heart disease (CHD) (including ECG consistent with prior myocardial infraction), cerebrovascular accident (including transient ischemic attack), peripheral vascular disease (including symptoms of claudication)
- •Angina or other chest pain that may indicate CHD by history
- •Clinically significant neoplastic, cardiovascular, hepatic, renal, metabolic, endocrine (untreated or unstable), or psychiatric (untreated or unstable) by history
- •Medications: Lipid lowering therapy, daily NSAID or greater than 325 mg ASA (PRN use ok), clopidogrel (or equivalent), Coumadin, other investigational drugs within 30 days of study entry
- •Pregnancy or planning pregnancy during the study period by history
- •Uncontrolled hypertension
- •Uncontrolled hypothyroidism
- •Sensitivity or allergy to product by history
- •Subjects who had undergone bypass procedure
- •Any debilitating disease such as tuberculosis, HIV by history .
- •Unwillingness to give written informed consent for participation in the study
研究组 & 干预措施
treament
Experimental
herbalife protein shake along with exercise
干预措施: herbalife protein shake (Dietary Supplement)
control
No Intervention
diet and exercise only
结局指标
主要结局
weight loss
时间窗: baseline to 3 months
次要结局
- improvement in lipid profile(baseline - 3 months)
研究者
Dr Anoop Misra
Director
Diabetes Foundation, India
研究点 (1)
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