Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Change from baseline in platelet activation at week 6 of each treatment
研究概览
简要总结
The purpose of this study is to determine how eating fish raised to have different levels of omega-3 fatty acids will reduce cardiovascular risk markers in people with elevated cardiovascular risk.
详细描述
Consumption of fish high in long chain omega-3 fatty acids (LCn3) is associated with reduction of cardiovascular disease (CVD) risk. CVD is a major cause of death in the United States. The current obesity epidemic contributes significantly to elevated CVD risk by increasing inflammation and platelet dysfunction. Prevention of CVD is a public health goal and comprises several avenues of action, of which inclusion of LCn3-rich fish in the diet may be one of the most effective.
Obese participants will participate in a double blind, randomized, cross-over designed trial in which they will consume twice-weekly a prepared meal containing diploid (2N) farmed rainbow trout, triploid (3N) farmed rainbow trout containing higher levels of LCn3, or tilapia, a low LCn3 fish.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI of 30 - 39.9 kg/m2
排除标准
- •Are allergic to fish
- •Use tobacco products or nicotine in any form including snuff, pills, and patches, or e-cigarettes in the past 6 months
- •Have established cardiovascular, pulmonary, and/or a metabolic disease such as diabetes
- •Have uncontrolled high blood pressure
- •Have alcohol, anabolic steroids, or other substance abuse issues
- •Consume more than 3 alcoholic drinks/week
- •Have cancer
- •Are pregnant or nursing
- •Take non-steroidal anti-inflammatory drugs such as aspirin, ibuprofen or Aleve, lipid modifying drugs such as statins, take medications for blood glucose such as insulin or metformin
结局指标
主要结局
Change from baseline in platelet activation at week 6 of each treatment
时间窗: Baseline, Week 6
次要结局
- Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in platelet fatty acids at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment(Baseline, Week 6)
- Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment(Baseline, Week 6)