NCT02455778已完成不适用
Effect of Intervention With Oral Cinnamon on Metabolic Profile and Body Composition of Asian Indians With Metabolic Syndrome in North India: A 16 Week Double Blind Placebo Control Trial
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Fasting Blood Glucose
研究概览
简要总结
This double blind placebo control study with supplementation of oral Cinnamon is being conducted to test the hypothesis that in subjects with Metabolic Syndrome oral cinnamon may lead to improvement in body composition and metabolic parameters.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 25 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 25 -65 years
- •Subjects identified with any three of following:
- •Fasting blood glucose ≥100 mg/ dL
- •Waist circumference ≥ 90 cm ( males) ≥ 80 cm (females)
- •Triglycerides ≥ 150 mg/dL
- •High density lipoprotein cholesterol ≤ 40 mg/dL ( in males) , ≤ 50 mg/dL (in females)
- •Blood pressure Systolic BP ≥ 130 mm Hg
- •Diastolic BP ≥ 85 mm Hg
- •Subjects who were willing to participate in the study.
- •Subjects, if on medication for high blood pressure were stable and there was no change in the dosage for the past 3 months.
排除标准
- •Subjects suffering from other chronic diseases and metabolic complications such as cardiovascular disease, diabetes, renal disease, myocardial infarction and other endocrine disorders.
- •Subjects who were allergic to wheat flour and cinnamon.
- •Subjects who were on medication of anti dyslipidemic or hypoglycemic drugs.
- •Subjects who had undergone bypass procedure.
- •Subjects suffering from any debilitating disease such as tuberculosis, HIV etc.
- •Subjects suffering from uncontrolled hypothyroidism/ hyperthyroidism
- •Pregnant and lactating mothers
结局指标
主要结局
Fasting Blood Glucose
时间窗: baseline to 4 months
次要结局
- HbA1c(baseline to 4 months)
- Lipid profile(baseline to 4 months)
- Body fat percentage(baseline to 4 months)
- Blood pressure(baseline to 4 months)
研究者
Dr Anoop Misra
Director
Diabetes Foundation, India
研究点 (1)
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