Clinical trial NCT02204709: Disease Risk Reduction and Omega-3 Rich Rainbow Trout (Fish for Health)
Official title: Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Keywords: obese
omega-3 fatty acids
fish
Lead sponsor: USDA Grand Forks Human Nutrition Research Center
Sponsor class: FED
First posted: 2014-07-30
Enrollment: 29
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* BMI of 30 - 39.9 kg/m2

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change from baseline in platelet activation at week 6 of each treatment
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment
timeFrame: Baseline, Week 6
measure: Change from baseline in platelet fatty acids at week 6 of each treatment
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Grand Forks
country: United States
facility: USDA Grand Forks Human Nutrition Research Center
state: North Dakota
Study officials:
affiliation: USDA Grand Forks Human Nutrition Research Center
name: Matthew Picklo, PhD
role: PRINCIPAL_INVESTIGATOR
References: