The Effects of Trout Fed With a Vegetable Based Feed on Cardiovascular Risk Markers and Plasma Proteome

Cardiovascular Disease Clinical Trial

Official title:

Healthy, Nutritious and Tasty Fish for the Future

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445614
• Other study ID #: M187
• Status: Completed
• Phase: N/A
• First received: March 8, 2007
• Last updated: August 12, 2008
• Start date: March 2007
• Est. completion date: December 2007

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

Fish from the aquaculture sector constitutes an increasing part of the fish consumption in Denmark. The most important farmed fish in Denmark is the rainbow trout. Due to limited access of wild fish for the feed production, alternative feeding regimes of vegetable origin such as vegetable proteins and rapeseed oil are used instead of marine feed. This change in feeding regime may affect flesh quality and health and nutritional properties as the content of long-chain n-3 polyunsaturated fatty acids (n-3 LCPUFA) will presumably decrease in the meat. The objective of the study is to investigate the effect of vegetable based feed versus marine feed of farmed trout and its effect in healthy men on cardiovascular risk markers associated with the development of cardiovascular disease (CVD).

Description:

In a two month parallel study including 60 healthy men aged 40-70 years, the cardiovascular effect of one daily meal of trout fed with a vegetable based feed are compared with that of trout fed with marine feed (estimated intake of n-3 LCPUFA 2.6 g/day) and a standard Danish diet with poultry. Men are randomised to one of the three groups. Red blood cell fatty acid composition, classical cardiovascular disease (CVD)-risk markers (blood pressure and plasma lipid profile), newer CVD-markers (arterial compliance and plasma markers of endothelial function and inflammation) and plasma proteome analysis are measured at the beginning and end of the intervention period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 70 Years

Eligibility

Inclusion Criteria:

• Age 40-70

• Body mass index 18,5 - 30

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: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases

Intervention

Behavioral:
• Effects of trout on CVD risk markers and plasma proteome

Locations

Country	Name	City	State
Denmark	Department of Human Nutrition, Denmark	Frederiksberg

Sponsors (3)

Lead Sponsor	Collaborator
University of Copenhagen	Danish Institute of Fisheries Research, The Ministry of Science, Technology and Innovation, Denmark

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
Primary	cardiovascular risk markers
Primary	markers of inflammation
Primary	plasma lipids