Possible Effects of Supplementation With Cis-9, Trans-11 Conjugated Linoleic Acid on Markers of Atherosclerosis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 401
- 试验地点
- 2
- 主要终点
- The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention.
研究概览
简要总结
Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the atherosclerosis development in several animal models. Studies in transgenic mice have shown that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers identified through platelet proteomics, has not been assessed before, and may add valuable insights into the mechanism of this functional fatty acid in humans.
Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.
Study design: The study is designed as a double blind randomised placebo controlled parallel group trial.
Study population: 400 men and women, between 40 and 70 years of age, with a body mass index of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.
Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects in the control arm receive 4 identical placebo capsules.
Main study parameters/endpoints: The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention.
详细描述
Rationale: Cis-9, trans-11 conjugated linoleic acid (CLA) can protect against the atherosclerosis development in several animal models. Studies in transgenic mice have shown that mechanisms might involve beneficial effects on lipoprotein metabolism and insulin sensitivity and in addition activation of anti-inflammatory pathways. A very limited amount of human studies have not shown similar beneficial effect of cis9,trans11-CLA on insulin sensitivity in obese subjects, yet cis9,trans11-CLA did improve the lipoprotein profile in healthy subjects. The effect of cis9,trans11-CLA supplementation on alternative early biomarkers of atherosclerosis, like aortic pulse wave velocity, and alternative biomarkers identified through platelet proteomics, has not been assessed before, and may add valuable insights into the mechanism of this functional fatty acid in humans.
Objective: To assess the effect of increased intake of cis9 trans11-CLA on development of atherosclerosis, as assessed with aortic pulse wave velocity and on alternative biomarkers.
Study design: The study is designed as a double blind randomised placebo controlled parallel group trial.
Study population: The study population comprises 400 men and women, between 40 and 70 years of age, with a body mass index of 25 kg/m2 or above. Subjects with previous symptomatic vascular disease or diabetes mellitus and subjects on blood pressure lowering or lipid lowering medication are excluded.
Intervention: Subjects in the intervention arm will receive daily 4 g of CLA oil (2.6 g cis9,trans11-CLA), 2 capsules to be taken in the morning and 2 in the evening. The subjects in the control arm receive 4 identical placebo capsules.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Written and signed informed consent
- •Healthy men and women
- •Between 40-70 years of age
- •Body mass index > 25 kg/m2
排除标准
- •Inability to understand the patient information
- •Inability to speak, read and understand the Dutch language
- •Indication (BP over 160/90) or using blood pressure lowering drugs
- •Indication (total cholesterol > 8 mmol/l) or using lipid lowering drugs
- •Indication (glucose > 7 mmol/l) or using glucose lowering drugs
- •Alcohol abuse (>21 alcoholic beverages per week)
- •Women who are pregnant, lactating or who are planning to become pregnant
- •Symptomatic vascular disease
- •Use of fish oils (omega 3/6,capsules or oil)
- •Use of plant stanols/sterols (margarines like benecol, pro active)
- •Use of weight loss supplements
- •Receipt of any investigational treatment (drug or device) within 30 days prior to visit 1
结局指标
主要结局
The main study outcome is difference between treatment arms in change in aortic pulse wave velocity after 6 months intervention.
时间窗: 6 months
次要结局
- change in serum lipids (total, LDL- and HDL cholesterol and triglycerides) and change in systolic and diastolic blood pressure and platelet biomarkers of haemostatic function (proteomics).(6 months)
研究者
Michiel L. Bots
Professor of Epidemiology of Cardiovascular Disease
UMC Utrecht