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临床试验/NCT03043365
NCT03043365已完成2 期

Effect of Fish Oil Enriched In Omega-11 Fatty Acid On Lipoprotein Metabolism In Adults

National Heart, Lung, and Blood Institute (NHLBI)1 个研究点 分布在 1 个国家目标入组 37 人开始时间: 2017年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
状态
已完成
入组人数
37
试验地点
1
主要终点
Changes From Baseline in Lipid Profile at 8 Weeks

研究概览

简要总结

Background:

Fish oils are known to be beneficial to health and believed to be cardio-protective. Omega-3 fatty acid is the most known fish oil available in the market. LCMUFA (long-chain monounsaturated fatty acids) is also a fish oil but it is derived from fish that consumes a diet rich in omega-11 fatty acid. Researchers want to study omega-11 fatty acid enriched fish oil and understand its effect on cardiovascular health.

Objective:

To understand the effects of LCMUFA from fish oil on cardiovascular health.

Eligibility:

Healthy volunteers ages 18 and older with no history of cardiovascular disease

Design:

Participants will be screened with:

  • Medical history
  • Physical exam
  • Fasting blood and urine tests
  • Optional stool sample
  • Questions about their diet, exercise, and the types of medicines and dietary supplements they take
  • 7-day food diary
  • Cardio-Ankle Vascular Index (CAVI): Blood pressure is taken in the arms and legs. The heart is monitored.
  • After the screening visit, participants will take 4 gel capsules, 3 times a day after meals, for 8-10 weeks.
  • Electrocardiogram (EKG)

Participants will have 3 additional visits. All include repeats of the screening tests.

Visit 2 is 8 weeks after the screening visit. Participants will stop taking the capsules for 8 weeks after this visit.

Visit 3 is at least 16 weeks after starting the supplement. Participants will take 4 capsules, 3 times a day after meals, for 8 weeks after this visit.

Visit 4 is 8 weeks after starting the second supplement.

详细描述

Serum cholesterol is transported by lipoproteins, such as very low-density lipoprotein (VLDL), low-density lipoproteins (LDL) and high-density lipoproteins (HDL), which vary in their relationship to cardiovascular disease risk. LDL, for example, is proatherogenic, whereas HDL is cardio-protective. Long-chain monounsaturated fatty acids (LCMUFA), fatty acids over 18 carbons in length with a single double bond, have been shown in mice to decrease proatherogenic lipoproteins, such as LDL, and reduce atherosclerosis. This study will test the hypothesis that LCMUFA supplementation in humans will favorably alter the lipoprotein lipid profile in regard to cardiovascular disease risk. In addition, we will assess other parameters related to lipoprotein composition and function, as well as other biomarkers related to coagulation and inflammation, which have previously been shown to be affected by supplementation with omega-3 fatty acids.

This clinical research project is designed as a pilot, randomized, double-blinded, crossover study that will investigate the effect of a fish oil enriched with LCMUFA on lipoprotein metabolism. Subjects will receive control fish oil enriched in oleic acid, a monounsaturated fatty acid (C18:1), or a fish oil supplement produced from Saury fish (rich in LCMUFA) for approximately 8-10 weeks, with a wash out period of 8-10 weeks between the two arms of the study. The study consists of 4 outpatient visits when laboratory or research samples and CAVI tests will be performed. A 7-day food diary, pill count, and red cell membrane fatty acid levels will be monitored to assess compliance.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Basic Science
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

Arm 1: Control Fish Oil first, then Saury Oil

Experimental

Subjects randomized to the control fish oil arm will take the equivalent to 3g of control /day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the LCMUFA-rich saury oil capsule arm

干预措施: control fish oil (Drug)

Arm 2: Saury Oil first, then Control Fish Oil

Experimental

Subjects randomized to the LCMUFA-rich saury oil arm will take the equivalent to 3g of control/day (12 gel capsules/day) for 8 plus or less 2 weeks and crossover to the control fish oil capsule arm

干预措施: LCMUFA-rich saury oil (Drug)

结局指标

主要结局

Changes From Baseline in Lipid Profile at 8 Weeks

时间窗: baseline and 8 weeks

The primary outcome measures of this study will be the change from baseline to end of intervention period (8 weeks) in the lipid profile (total cholesterol (TC), triglycerides (TG), high-density lipoprotein cholesterol (HDL-C), low-density lipoprotein cholesterol (LDL-C)) for the control and research supplement groups.

次要结局

  • Changes Lipoprotein Particle Number, Composition and Size (sdLDL, LDL-TG, ApoE-HDL, ApoA-I, ApoB)(baseline and 8 weeks)
  • Changes Lipoprotein Particle Number, Composition and Size in Oxidized Low-density Lipoprotein (oxLDL)(baseline and 8 weeks)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (1)

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