Fish Oil and Biomarkers of Cardiovascular Risk
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 3
- 试验地点
- 2
- 主要终点
- Blood Pressure
研究概览
简要总结
Rationale Experimental data indicate an inverse relation between intake of omega-3 fatty acids ('fish oil'), primarily in the form of eicosapentanoic acid (EPA) and docosahexanoic acid (DHA), and risk of developing cardiovascular disease in healthy adults. Mechanisms underlying this cardioprotective effect are unknown but may involve favorable influences on various biomarkers of cardiovascular risk. In this project we will determine if these favorable effects of omega-3's occur in older healthy adults, as aging is a primary risk factor for cardiovascular disease development.
Key Objectives To determine the effect of chronic (12 week) oral omega-3 fatty acid supplementation on biomarkers of cardiovascular risk in young and older adults. We hypothesize that omega-3 fatty acid supplementation will exert positive effects on biomarkers of cardiovascular risk.
Study Population Healthy young (18-40 years of age) and older (50-79) men and women.
Major Inclusion & Exclusion Criteria Subjects must be healthy (as assessed by history and physical examination: non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results. Women must be non-pregnant. Normal liver enzymes (ALT and AST). Individuals with allergies to corn will be excluded.
Allocation to Groups Randomized, double-blinded, and placebo-controlled.
Summary of Procedures Measurements will be made at baseline and repeated ~12 weeks after beginning daily oral ingestion of either low dose or high dose fish oil capsules or placebo
详细描述
N/A - withdrawn
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subjects must be healthy (as assessed by history and physical examination:
- •Non obese BMI<30: normotensive BP <140/90 mmHg) men and women not currently taking medications that could influence the results.
- •Women must be non-pregnant.
- •Normal liver enzymes (ALT and AST).
排除标准
- •Individuals with allergies to corn will be excluded.
结局指标
主要结局
Blood Pressure
时间窗: every 2 weeks for a 12 week duration
Blood pressure will be measured using a cuff placed around the subject's upper arm as well as a small cuff placed on their finger.
Heart Rate
时间窗: every two weeks for 12 week duration
Two-inch square adhesive patches will be used to monitor your heart rate
Aortic Blood Pressure
时间窗: every two weeks, for a 12 week duration
Aortic Blood pressure will be measured non-invasively by pressing an ultrasound probe against an artery in the neck or wrist.
Brachial Artery Blood flow: After Nitroglycerin (0.4mg)
时间窗: every two weeks, for a 12 week duration
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after placing a pill containing nitroglycerin (0.4mg) under the tongue.
Microneurography
时间窗: every two weeks, for a 12 week duration
Two very fine, sterile nerve wires (micro-electrodes), thinner than a sewing needle, will be introduced through the skin into a nerve located just under the skin of the right leg. This procedure will measure nerve activity from the brain to the leg.
Arterial Pulse Wave Velocity
时间窗: every two weeks, for a 12 week duration
The speed at which blood travels through arteries in the subject's torso will be measured non-invasively using Doppler Flow probes.
Brachial Artery Blood Flow
时间窗: every two weeks, for a 12 week duration
The blood flow into the subject's brachial artery will be measured non-invasively using an ultrasound probe after deflation of a blood pressure cuff that previously had been inflated tightly on the upper forearm for a period of 5 minutes
次要结局
- Blood Withdrawal(every two weeks, for a 12 week duration)