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临床试验/NCT02670356
NCT02670356终止不适用

Study Comparing Fish Oil and Krill Oil

Tufts University2 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2015年10月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
2
试验地点
2
主要终点
Omega-3 index

研究概览

简要总结

Eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA) are omega-3 fatty acids found in fish oil and in krill oil. The purpose of this study is to compare the effects of the recommended dose of a fish oil supplement (Omax3 4:1 EPA:DHA; recommended daily dose 1650 mg - totaling 1500 mg EPA+DHA) and a krill oil supplement (MegaRed; recommended daily dose 300 mg - totaling 74 mg EPA+DHA) on omega-3 index, plasma biomarkers of inflammation and inflammatory cell activation, and plasma lipid levels in subjects with metabolic syndrome.

详细描述

Inflammation plays a pivotal role in the pathogenesis of several chronic diseases including cardiovascular disease and diabetes mellitus. There has been some evidence that fish oil, containing the omega-3 fatty acids eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), reduces the risk or severity of these diseases, leading several government and health organizations to advocate an increased consumption of fish or fish oil. Fish oil contains EPA and DHA either as triglycerides or as ethyl esters. Recently, krill oil has gained popularity as an EPA and DHA supplement. Krill oil contains EPA and DHA in phospholipid, triglyceride, and free fatty acid form.

Some studies have shown that the bioavailability of EPA and DHA in krill oil is higher than in fish oil and that smaller doses of krill oil are therefore sufficient to observe a significant effect on the desired outcome (inflammation, plasma lipid levels).

The central hypothesis of this proposal is that the dose of the EPA and DHA omega-3 fatty acids is more important than their bioavailability in effecting changes in systemic inflammation and lipid metabolism.

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
None

入排标准

年龄范围
50 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • fasting plasma triglyceride levels between 150 and 500 mg/dL
  • C-reactive protein (CRP) levels ≥2 µg/mL
  • at least one of the following criteria for the definition of metabolic syndrome: abdominal obesity (waist circumference >40 inches in men and >35 inches in women), hypertension (blood pressure ≥130/≥85 mmHg or use of anti-hypertensive medications), and fasting glucose ≥110 mg/dL.

排除标准

  • high-fish diets (>2 fish meals/week)
  • taking fish oil supplements or supplements containing EPA or DHA
  • regular use of anti-inflammatory medications
  • Above normal coagulation time or use of anticoagulant medications
  • allergy to fish, fish oil, or shellfish
  • uncontrolled thyroid dysfunction
  • insulin-dependent type 2 diabetes mellitus
  • kidney or liver disease
  • drinking more than 7 alcoholic drinks/week
  • use of lipid-lowering medications or medications known to alter lipoprotein metabolism

结局指标

主要结局

Omega-3 index

时间窗: 10 weeks

red blood cell membrane levels of EPA and DHA, as percent of total fatty acids

次要结局

  • Tumor necrosis factor alpha (TNF-alpha)(10 weeks)
  • Monocyte chemoattractant protein 1 (MCP-1)(10 weeks)
  • Total cholesterol(10 weeks)
  • interleukin-6 (IL-6)(10 weeks)
  • LDL cholesterol(10 weeks)
  • HDL cholesterol(10 weeks)
  • TG(10 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Stefania lamon-Fava

Scientist I. Associate Professor

Tufts University

研究点 (2)

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