NCT00160108已完成1 期
A Dietary Intervention- Randomized Controlled Trial (DIRECT) Study; BGU-Harvard-Robarts Collaboration
The S. Daniel Abraham International Center for Health and Nutrition2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2005年7月1日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 2
- 主要终点
- weight loss
研究概览
简要总结
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss
详细描述
Aim-to conduct a randomized clinical intervention study to compare three diets (low-fat, low-carbohydrate and Mediterranean diet) for weight loss
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
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •History of CHD or diabetes in any age or BMI level
排除标准
- •Pregnant or lactating women.
- •Active drug or alcohol use or dependence that, in the opinion of the site investigator, would interfere with adherence to study requirements.
- •Serum creatinine > 3 mg/dl.
- •Liver dysfunction ( ³ 2 fold level of ALT and AST enzymes).
- •Participation in another trial in which active intervention is being received.
- •Any intestinal problem that would prevent the patient from eating one of the test diets (for example, gastric stapling that might prevent consumption of vegetables).
结局指标
主要结局
weight loss
次要结局
- CVD mediators measurements
研究者
研究点 (2)
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