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

August 12, 2008 updated by: University of Copenhagen

Healthy, Nutritious and Tasty Fish for the Future

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Anticipated)

72

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg, Denmark, 1958
        • Department of Human Nutrition, Denmark

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Marine trout
150 g/day of trout fed on marine based feed
Behavioral: Effects of trout on CVD risk markers and plasma proteome
Experimental: Vegetable trout
150 g/d of trout fed on vegetable based feed
Behavioral: Effects of trout on CVD risk markers and plasma proteome
Other: Poultry
150 g/d of poultry (for comparison)
Behavioral: Effects of trout on CVD risk markers and plasma proteome

What is the study measuring?

Primary Outcome Measures

Outcome Measure
markers of inflammation
blood pressure
plasma protein expression
plasma lipids
pulse wave velocity
pulse wave analysis
cardiovascular risk markers

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

The Ministry of Science, Technology and Innovation, Denmark
Danish Institute of Fisheries Research

Investigators

  • Principal Investigator: Lotte Lauritzen, ph.d., University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

March 8, 2007

First Submitted That Met QC Criteria

March 8, 2007

First Posted (Estimate)

March 9, 2007

Study Record Updates

Last Update Posted (Estimate)

August 14, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M187

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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