Disease Risk Reduction and Omega-3 Rich Rainbow Trout (Fish for Health)

Condition(s) targeted: Obese; Metabolic Syndrome

Intervention: 2N Trout (Other); 3N Trout (Other); Tilapia (Other)

Phase: N/A

Status: Recruiting

Sponsored by: USDA Grand Forks Human Nutrition Research Center

Official(s) and/or principal investigator(s):
Matthew Picklo, PhD, Principal Investigator, Affiliation: USDA Grand Forks Human Nutrition Research Center
Susan Raatz, PhD, RD, Principal Investigator, Affiliation: USDA Grand Forks Human Nutrition Research Center

Overall contact:
Matthew Picklo, PhD, Phone: 701-795-8380, Email: matthew.picklo@ars.usda.gov

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.

Official title: Disease Risk Reduction and n-3 Rich Rainbow Trout (Fish for Health)

Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Change from baseline in platelet activation at week 6 of each treatment

Secondary outcome:

Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment

Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment

Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment

Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment

Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment

Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment

Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment

Change from baseline in platelet fatty acids at week 6 of each treatment

Minimum age: 35 Years. Maximum age: 70 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

- BMI of 30 - 39. 9 kg/m2

- Meet 3 out of 5 of the following:

1. Abdominal circumference: men > 102 cm, women > 88 cm 2. Triglycerides ≥ 150 mg/dL 3. HDL cholesterol: men < 40 mg/dL, women < 50 mg/dL 4. Blood pressure ≥ 130/85 mm Hg 5. Fasting glucose ≥ 100 mg/dL Exclusion Criteria:

- Are allergic to fish

- Blood pressure > 160/99 mm Hg

- Blood glucose ≥ 126 mg/dL

- 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

Matthew Picklo, PhD, Phone: 701-795-8380, Email: matthew.picklo@ars.usda.gov

USDA Grand Forks Human Nutrition Research Center, Grand Forks, North Dakota 58203, United States; Recruiting
Angela Scheett, MPH, RD, Phone: 701-795-8386, Email: angela.scheett@ars.usda.gov

Starting date: June 2015
Last updated: June 12, 2015