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
- 1
- 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
研究组 & 干预措施
Diploid Trout entrees
Subjects will consume a 200 gram portion of 2N trout (diploid; two sets of chromosomes) twice weekly in a prepared meal.
干预措施: 2N Trout (Other)
Triploid Trout entrees
Subjects will consume a 200 gram portion of 3N trout (triploid; three sets of chromosomes) twice weekly in a prepared meal.
干预措施: 3N Trout (Other)
Tilapia entrees
Subjects will consume a 200 gram portion of tilapia twice weekly in a prepared meal.
干预措施: Tilapia (Other)
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 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 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 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)