NCT01690312已完成不适用
Clinical Study to Assess the Acute and Chronic Effects of a High-DHA Fish Oil on Fasting and Post-Prandial Biomarkers of Cardiovascular Disease Risk in Adults on Statin Therapy.
Nutrasource Pharmaceutical and Nutraceutical Services, Inc.2 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2012年9月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Triglyceride [TG]
研究概览
简要总结
The objective of this study is to determine the acute and chronic [4-week] effects of a high-DHA fish oil supplement on fasting and post-prandial (post-meal) biomarkers of cardiovascular disease risk, in adults on Statin therapy.
详细描述
This study involves fasted and post-prandial components.
Fasted Study:
Participants will provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo] in Treatment Period I. Participants will again provide fasting blood samples pre-and post-intervention [4-week administration of supplement or placebo, opposite to Treatment Period I] during Treatment Period II.
There will be a 4-week washout period during the two Treatment Periods.
Post-prandial study:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be an adult between the ages of 18 and 70;
- •Be a male or a post-menopausal female who has gone a minimum of one year since their last menses;
- •Be taking Statin medication at a stable dose for a minimum of four weeks prior to study commencement [and whom have reached a target LDL level];
- •Have elevated fasting triglyceride levels [greater than 1.5 mmol/L but less than 5.7 mmol/L];
- •Have fasting blood glucose levels below the study cut-off [less than 7.0 mmol/L];
- •Have a Body Mass Index (BMI) less than 35.0
- •Be taking natural health products BUT agree to cease consumption during the study period and a 4-week pre-study washout prior to study commencement. Study participants will be allowed to consume a daily multivitamin if they have been doing so at a stable dose for a minimum of three months prior to study commencement.
排除标准
- •Be younger than 18 years of age or older than 70 years of age;
- •Be an adult pre- or peri-menopausal female;
- •Not have taken Statin medication at a stable dose for a minimum of 4 weeks prior to study commencement;
- •Have fasting triglyceride levels outside of study limits[ie/ less than 1.5 mmol/L or greater than 5.7 mmol/L];
- •Have elevated fasting blood glucose levels [greater or equal to 7.0 mmol/L];
- •Have high blood pressure [greater than 140/100]
- •Have a Body Mass Index (BMI) equal to or greater than 35.0
- •Have a pre-existing cardiovascular disease or illness, including angina, myocardial infarction, stroke, intermittent claudication or transient ischemic attack;
- •Have a known allergy to fish and/or fish oil, olive oil, soy or Vitamin E;
- •Be taking natural health products but are unwilling to cease consumption during the study period and a 4-week pre-study washout prior to study commencement;
- •Consume more than two (2) fish meals on a weekly basis
- •Consume excessive amounts of alcohol on a weekly basis [more than 10 alcoholic drinks per week];
- •Anticipate or have planned surgery during the course of the study.
结局指标
主要结局
Triglyceride [TG]
时间窗: 0 and 4 weeks
Fasted and postprandial samples will be drawn (hourly up to 6 hours).
次要结局
- High-density lipoprotein [HDL](0 and 4 weeks)
- Homocysteine(0 and 4 weeks)
- Insulin(0 and 4 weeks)
- Lipoprotein A(0 and 4 weeks)
- Glucose(0 and 4 weeks)
- Low-density lipoprotein [LDL](0 and 4 weeks)
- Very low-density lipoprotein [VLDL](0 and 4 weeks)
- Remnant Lipoproteins(0 and 4 weeks)
- Apolipoprotein B(0 and 4 weeks)
- Total cholesterol [TC](0 and 4 weeks)
- High-sensitivity C-Reactive Protein [hs-CRP](0 and 4 weeks)
- Intermediate-density lipoprotein [IDL](0 and 4 weeks)
- Essential Fatty Acid Profile(0 and 4 weeks)
- Apolipoprotein A-1(0 and 4 weeks)
研究者
研究点 (2)
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