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临床试验/NCT02144636
NCT02144636已完成不适用

Effect of Protein Supplementation on Weight Loss and Cardio Metabolic Profile of Overweight/Obese Subjects

Diabetes Foundation, India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2012年11月1日最近更新:
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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Anoop Misra

Director

Diabetes Foundation, India

研究点 (1)

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