NCT01925716已完成不适用
A Randomized Double Blind Controlled Crossover Trial to Assess the Effects of Dietary Oils on Fasting Lipoprotein Lipids
ACH Food Companies, Inc.0 个研究点目标入组 57 人开始时间: 2013年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 57
- 主要终点
- Low Density Lipoprotein cholesterol
研究概览
简要总结
The objectives of this clinical trial are to assess the effects of dietary oils on blood lipids and other aspects of the fasting lipoprotein profile in healthy men and women with elevated cholesterol
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fasting LDL-C level equal to or greater than 130 mg/dL and less than 200 mg/dL at visit 1
- •Fasting triglycerides less than or equal to 350 mg/dL at visit 1
排除标准
- •Has coronary heart disease or coronary heart disease risk risk equivalent, such as diabetes, atherosclerosis, etc
- •Taking lipid medications intended to alter the lipids profile, including but not limited to statins, bile acid sequestrants, etc.
- •Uncontrolled hypertension (systolic greater than or equal to 160 mm Hg or diastolic greater than or equal to 100 mm Hg)
结局指标
主要结局
Low Density Lipoprotein cholesterol
时间窗: Time Frame: baseline (average days -7 and 0) and the end of each treatment period [Treatment 1 averages of days 19 and 21and Treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks
次要结局
- total cholesterol(baseline (average of days -7 and 0) and the end of each treatment period [Treatment I average of days 19 and 21) and treatment II (average of days 19 and 21)]: patients are followed for an average of 11 weeks)
研究者
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