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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00445614
First Posted: March 9, 2007
Last Update Posted: August 14, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
The Ministry of Science, Technology and Innovation, Denmark
Danish Institute of Fisheries Research
Information provided by:
University of Copenhagen
  Purpose
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).

Condition Intervention
Cardiovascular Disease Behavioral: Effects of trout on CVD risk markers and plasma proteome

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
Primary Purpose: Prevention
Official Title: Healthy, Nutritious and Tasty Fish for the Future

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • plasma protein expression
  • blood pressure
  • pulse wave analysis
  • pulse wave velocity
  • cardiovascular risk markers
  • markers of inflammation
  • plasma lipids

Estimated Enrollment: 72
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
Poultry
150 g/d of poultry (for comparison)
Behavioral: Effects of trout on CVD risk markers and plasma proteome

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00445614


Locations
Denmark
Department of Human Nutrition, Denmark
Frederiksberg, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
The Ministry of Science, Technology and Innovation, Denmark
Danish Institute of Fisheries Research
Investigators
Principal Investigator: Lotte Lauritzen, ph.d. University of Copenhagen
  More Information

Responsible Party: Lotta Lauritzen, Dept. of Human Nutrition, University of Copenhagen
ClinicalTrials.gov Identifier: NCT00445614     History of Changes
Other Study ID Numbers: M187
First Submitted: March 8, 2007
First Posted: March 9, 2007
Last Update Posted: August 14, 2008
Last Verified: August 2008

Keywords provided by University of Copenhagen:
nutrition
cardiovascular risk
inflammation
vascular function

Additional relevant MeSH terms:
Cardiovascular Diseases