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

Information source: USDA Grand Forks Human Nutrition Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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

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.

Clinical Details

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

Eligibility

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

Locations and Contacts

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
Additional Information

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

Page last updated: August 23, 2015

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