Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome

Cardiovascular Diseases Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00432952
• Other study ID #: M186
• Status: Active, not recruiting
• Phase: N/A
• First received: February 7, 2007
• Last updated: August 12, 2008
• Start date: January 2007
• Est. completion date: January 2009

Study information

• Verified date: August 2008
• Source: University of Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial Summary

The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated.

The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.

Description:

In a controlled, single blinded human single meal study the acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. 6 healthy men, age 40-70, will be randomized to trout fed on only vegetable, only marine and a mix of different compositions of vegetable and marine feeds. Outcome variables are blood pressure, pulse wave analyse, pulse wave velocity, plasma protein profile, and plasma triglycerides.

The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 6
• Est. completion date: January 2009
• Est. primary completion date: March 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Non regular smokers

• Body Mass Index (18.5-30 kg/m2)

• Able to eat fish

Exclusion Criteria:

• Exercise >10 h/week

• Chronical diseases (eg. cardiovascular and diabetes)

• Regular medication

• Fish oil supplementation

• Blood donation 2 month prior or during participation

• Above maximum recommended alcohol intake

• Blood pressure >160/100 mm Hg

Study Design

Allocation: Randomized, Endpoint Classification: Bio-availability Study, Intervention Model: Crossover Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Metabolic Syndrome
• Metabolic Syndrome X

Intervention

Behavioral:
• Intake of rainbow trout from different feeding conditions versus a control poultry meal

Locations

Country	Name	City	State
Denmark	Institute of Human Nutrition, University of Copenhagen	Frederiksberg C

Sponsors (2)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Institute of Fisheries Research

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	plasma protein expression
Primary	Blood Pressure
Primary	Pulse Wave Analysis
Primary	Pulse wave Velocity
Secondary	Plasma Triglycerides