Obesity
Conditions
Keywords
obese, omega-3 fatty acids, fish
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.
Interventions
OTHER2N Trout
Diploid/2N trout source
OTHER3N Trout
Triploid/3N trout source
OTHERTilapia
Tilapia/control fish source
Sponsors
USDA Grand Forks Human Nutrition Research Center
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 70 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in platelet activation at week 6 of each treatment | Baseline, Week 6 |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in plasma tumor necrosis factor alpha (TNFa) 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 thromboxane B2 (TxB2-M) 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 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 platelet fatty acids 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 |
Countries
United States
Outcome results
None listed