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Completed

NCT Number: NCT00445614

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

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).

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Key information

Conditions

Cardiovascular Disease Cardiovascular Diseases Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Department of Human Nutrition, Denmark

Frederiksberg, 1958, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Effects of trout on CVD risk markers and plasma proteome

Behavioral

Primary outcomes

  1. plasma protein expression

  2. blood pressure

  3. pulse wave analysis

  4. pulse wave velocity

  5. cardiovascular risk markers

  6. markers of inflammation

  7. plasma lipids

Sponsors and collaborators

Lead sponsor

University of Copenhagen

Other

Collaborators

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

Registry information

Official study title

Healthy, Nutritious and Tasty Fish for the Future

Important dates

Study start
2007
Primary completion
2007
Study completion
2007
First posted
Mar 9, 2007
Registry last updated
Aug 14, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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