NCT02008838已完成2 期
Effects of Synbiotic Supplementation in Metabolic Syndrome
National Nutrition and Food Technology Institute0 个研究点目标入组 38 人开始时间: 2012年4月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 38
- 主要终点
- HOMA-IR
研究概览
简要总结
To evaluate the effects of synbiotic supplementation on insulin resistance, and lipid profile in subjects with metabolic syndrome, in a randomized, double-blind, placebo-controlled pilot study, 38 subjects with metabolic syndrome will be supplemented with either synbiotic or placebo capsules twice/day for 28 weeks. Both the synbiotic (G1) and the placebo (G2) groups will be advised to follow an energy balanced diet and physical activity recommendations. Parameters related to metabolic syndrome and insulin resistance will be measured every 7 weeks during the study course.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years of age and older
- •having three of the following five features: Increased waist circumference (≥102 cm in men and ≥88 cm in women), elevated TG (≥150 mg/dl), reduced HDL-C (≤40 mg/dl in men and ≤50 mg/dl in women), elevated blood pressure (≥130/85 mm Hg or on treatment for hypertension) and elevated glucose (≥100 mg/dl), according to the National Cholesterol Education Program Adult Treatment Panel III report
- •BMI : 25≥ BMI ≥ 40
排除标准
- •Use antibiotic 2 weeks before recruitment to the study
- •A history of alcohol consumption
- •Pregnancy & Breast feeding , Professional athelets
- •A history of Cardiovascular disease, Pulmonary disease, Renal disease & Celiac disease
结局指标
主要结局
HOMA-IR
时间窗: 28 weeks
次要结局
未报告次要终点
研究者
Dr Azita Hekmatdoost
Assisstant Prof
National Nutrition and Food Technology Institute
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