NCT00529828已完成不适用
Health Effects of CLA Versus Industrial Trans Fatty Acids in Healthy Volunteers (CLARINeT-Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Total cholesterol
研究概览
简要总结
The knowledge of the health effects of CLA on the human body is limited. However, CLA supplements are sold over the counter in several countries and various techniques are used to increase the content of CLA in food.
The CLARINeT study will be performed to investigate the effect of CLA on blood lipoproteins, inflammatory markers, blood pressure and insulin status in human volunteers relative to industrial trans fatty acids and to oleic acid.
详细描述
It will be a double-blind randomized multiple cross-over trial with 3 treatments:
- CLA;
- Industrial trans fatty acids (as a positive control);
- Oleic acid (Cis 18:1, the monounsaturated fatty acid in unhydrogenated vegetable oils) as a reference fat.
Each volunteer receives each diet for three weeks, in random order, for a total of 9 weeks. Three weeks is sufficient to reach new stable lipoprotein levels.
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •age 18-65 years
排除标准
- •serum total cholesterol >= 6,5 mmol/L
- •serum triglycerides > 2,3 mmol/L
- •chronic diseases (such as diabetes, cardiovascular disease, kidney and liver dysfunction)
- •use of cholesterol lowering medication
- •use of blood pressure lowering medication
- •high alcohol intake
- •BMI > 30
- •pregnant and lactation women
- •unusual dietary requirements
结局指标
主要结局
Total cholesterol
HDL cholesterol
LDL cholesterol
Apo B
Triglycerides
次要结局
- Insulin status markers : HOMA; QUICKY
- Inflammatory markers: C-RP; IL-6; E-selectin; MCP-1; s-TNF-R1; s-TNF-R2; IFg
- Fatty acid composition of cholesteryl esters and erythrocytes
- proteomics
- iso-prostanes
- blood pressure and heart rate
研究者
研究点 (2)
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