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

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02204709
• Other study ID #: GFHNRC029
• Status: Terminated
• Phase: N/A
• Start date: June 2015
• Est. completion date: March 25, 2020

Study information

• Verified date: August 2022
• Source: USDA Grand Forks Human Nutrition Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 29
• Est. completion date: March 25, 2020
• Est. primary completion date: March 25, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• 2N Trout
Diploid/2N trout source
• 3N Trout
Triploid/3N trout source
• Tilapia
Tilapia/control fish source

Locations

Country	Name	City	State
United States	USDA Grand Forks Human Nutrition Research Center	Grand Forks	North Dakota

Sponsors (1)

Lead Sponsor	Collaborator
USDA Grand Forks Human Nutrition Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in platelet activation at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in plasma interleukin-6 (IL-6) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in plasma tumor necrosis factor alpha (TNFa) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in urinary prostaglandin E2 (PGE2) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in urinary thromboxane B2 (TxB2-M) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in urinary prostaglandin I2 (PGI2-M) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in serum thromboxane B2 (TxB2) at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in plasma phospholipid fatty acids at week 6 of each treatment		Baseline, Week 6
Secondary	Change from baseline in platelet fatty acids at week 6 of each treatment		Baseline, Week 6

External Links

•   Grand Forks Human Nutrition Research Center Current Nutrition Studies