A Double-blind, Randomized, Placebo-controlled, Crossover Trial to Assess the Effects of 4 g/d Prescription Omega-3 Acid Ethyl Esters on Indices of Glucose Homeostasis and Lipoprotein Lipids in Subjects With Hypertriglyceridemia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
研究概览
简要总结
The objectives of this study are to assess the effects of 4 g/d prescription omega-3 acid ethyl esters (POM3), compared with a placebo, on indices of insulin sensitivity and secretion, as well as aspects of the fasting and postprandial lipid and lipoprotein profiles, in subjects with hypertriglyceridemia.
详细描述
This trial will utilize a randomized, double-blind, two-period crossover design. At Visit 2 (Week 0), subjects meeting all entry criteria will be randomized to one of two treatment sequences: placebo or POM3 for the first 6 week phase followed by the study product they did not receive during the first phase (POM3 or placebo) for the second 6 weeks. There will be a 2-week washout period between treatment phases.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and postmenopausal women, ages 18-79 years.
- •Fasting, triglyceride (TG) level in the borderline high to high range.
- •Fasting, low density lipoprotein cholesterol (LDL-C) below the very high range while on no lipid altering therapy or while taking stable-dose statin therapy
- •Provide written informed consent and authorization for protected health information
排除标准
- •Use of any lipid-altering medications, which cannot be stopped, except stable dose statin therapy.
- •Use of any omega-3 fatty acid ethyl ester medications or dietary supplements with >1.0 g/d of eicosapentaenoic acid (EPA), docosahexaenoic acid (DHA), or a combination of EPA and DHA
- •coronary heart disease (CHD) or a CHD risk equivalent
- •Body mass index over 45 kg per square meter
- •Allergy or sensitivity to omega-3 fatty acids, corn or corn products (e.g., corn oil), D-alpha tocopherol (vitamin E) or any ingredients in the study drug
- •Certain muscle, liver, kidney, lung or gastrointestinal conditions
- •Poorly controlled hypertension
- •Certain medications
- •Active cancers treated within prior 2 years (except non-melanoma skin cancer)
研究组 & 干预措施
POM3
POM3 for the first six weeks of treatment. Placebo for the second six weeks of treatment
干预措施: POM3 (Drug)
Placebo
Placebo for the first six weeks of treatment. POM3 for the second six weeks of treatment
干预措施: Placebo (Drug)
结局指标
主要结局
Difference Between Treatments in Liquid Meal Tolerance Test (LMTT) Matsuda Insulin Sensitivity Index (MISI).
时间窗: End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14)
Liquid meal tolerance test (LMTT) = two 8 oz servings of Ensure (Abbott Nutrition) + study product followed by blood sample collection at -5, -1, 30, 60, 90, 120, 180, and 240 min, where t = 0 was start of liquid meal consumption. MISI calculated as 10,000/square root of (pre-meal glucose x pre-meal insulin x mean 120 min post-meal glucose x mean 120 min post-meal insulin)
次要结局
- Difference Between Treatments in LMTT Insulin Secretion Index and Disposition Index.(End of Treatment Intervention Period I (week 6) and End of Treatment Intervention Period II (week 14))
研究者
Kevin C. Maki, PhD
Study Director/Chief Science Officer
Provident Clinical Research