Omacor: Measures of Endothelial Function and triGlyceride Alteration
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Blood Pressure
研究概览
简要总结
The purpose of this study is to evaluate the cardiovascular and lipid effects of two doses of an omega-3 fatty acid concentrate in a group of people who normally are not treated for high lipids.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 21 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •triglycerides 150-500 mg/dL
- •age 21-65 years
- •generally healthy
- •body mass index (BMI) 20-39 kg/m2
排除标准
- •premenopausal (if female)
- •use of hormone replacement or oral contraceptives
- •use of lipid lowering or blood pressure medication
- •hypertension (blood pressure > 150/95 mm Hg)
- •peripheral vascular disease
- •heart disease, diabetes, or stroke
- •inflammatory disease (e.g. rheumatoid arthritis or Crohn's)
- •elevated liver enzymes
- •high intake of omega-3 containing foods
- •allergy to adhesive or latex
- •use of aspirin, anticoagulants, or SSRI
研究组 & 干预措施
4g P-OM3, then 1g P-OM3, then Placebo
4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
干预措施: 4/day of 4g P-OM3 capsules (Drug)
4g P-OM3, then 1g P-OM3, then Placebo
4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
干预措施: 4/day of 1g P-OM3 capsules (Drug)
4g P-OM3, then 1g P-OM3, then Placebo
4 g/day Dose Prescription Omega-3 acid ethyl esters (P-OM3)capsules(4) for first intervention (8 weeks), followed by 1g/day P-OM3 capsules(4) for 2nd intervention (8 weeks), followed by Placebo corn oil capsules, 4/day, for the 3rd intervention (8 weeks).
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
1g P-OM3, then 4g P-OM3, then Placebo
1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
干预措施: 4/day of 4g P-OM3 capsules (Drug)
1g P-OM3, then 4g P-OM3, then Placebo
1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
干预措施: 4/day of 1g P-OM3 capsules (Drug)
1g P-OM3, then 4g P-OM3, then Placebo
1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks,followed by 6-wk washout. Placebo capsules for 8-wks.
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
干预措施: 4/day of 4g P-OM3 capsules (Drug)
Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
干预措施: 4/day of 1g P-OM3 capsules (Drug)
Placebo, then 4g P-OM3, then 1g P-OM3
Corn Oil placebo capsules for 8-wks, followed by 6-wk washout. 4g P-OM3 capsules for 8-wks, followed by 6-wk washout. 1g P-OM3 for 8-wks.
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
4g P-OM3, then Placebo, then 1g P-OM3
4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
干预措施: 4/day of 4g P-OM3 capsules (Drug)
4g P-OM3, then Placebo, then 1g P-OM3
4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
干预措施: 4/day of 1g P-OM3 capsules (Drug)
4g P-OM3, then Placebo, then 1g P-OM3
4g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 1g capsules for 8 wks.
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
1g P-OM3, then Placebo, then 4g P-OM3
1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: 4/day of 4g P-OM3 capsules (Drug)
1g P-OM3, then Placebo, then 4g P-OM3
1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: 4/day of 1g P-OM3 capsules (Drug)
1g P-OM3, then Placebo, then 4g P-OM3
1g capsules for 8-wks, followed by 6-wk washout. Placebo capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
Placebo, then 1g P-OM3, then 4g P-OM3
Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: 4/day of 4g P-OM3 capsules (Drug)
Placebo, then 1g P-OM3, then 4g P-OM3
Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: 4/day of 1g P-OM3 capsules (Drug)
Placebo, then 1g P-OM3, then 4g P-OM3
Corn oil placebo capsules for 8-wks, followed by 6-wk washout.1g capsules for 8-wks, followed by 6-wk washout. 4g capsules for 8 wks.
干预措施: Corn Oil Placebo, 4 capsules/day for 8 weeks (Drug)
结局指标
主要结局
Blood Pressure
时间窗: 8 weeks
Effect of P-OM3 dose on blood pressure
Flow-mediated Dilation (FMD)
时间窗: 8 weeks
Effect of P-OM3 dose on FMD, which is measured as percent change in brachial artery diameter at peak dilation vs. baseline following a 5-minute occlusion period.
Heart Rate
时间窗: 8 weeks
Effect of P-OM3 dose on heart rate
Lipid Profile
时间窗: 8 weeks
Plasma/serum samples were analyzed at baseline and at the end of each 8-week treatment period to evaluate the effect of P-OM3 dose on triglycerides, HDL-C, LDL-C, and total cholesterol.
次要结局
- Cytokine Inflammatory Markers(8 weeks)
- Fasting Glucose(8 weeks)
- Erythrocyte Fatty Acids(8 weeks)
- Fasting Insulin(8 weeks)
- Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) and Quantitative Insulin Sensitivity Check Index (QUICKI)(8 weeks)
- Psychosocial Profile Questionnaires(8 weeks)
- C-reactive Protein (CRP)(8 weeks)
研究者
Sheila G West
Professor of Biobehavioral Health
Penn State University