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| Sponsors and Collaborators: |
University of Copenhagen The Ministry of Science, Technology and Innovation, Denmark Danish Institute of Fisheries Research, Denmark |
|---|---|
| Information provided by: | University of Copenhagen |
| ClinicalTrials.gov Identifier: | NCT00445614 |
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: | Prevention, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study |
| Official Title: | Healthy, Nutritious and Tasty Fish for the Future |
| 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 |
|---|---|
|
Marine trout: Experimental
150 g/day of trout fed on marine based feed
|
Behavioral: Effects of trout on CVD risk markers and plasma proteome |
|
Vegetable trout: Experimental
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 |
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| Ages Eligible for Study: | 40 Years to 70 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Denmark | |
| Department of Human Nutrition, Denmark | |
| Frederiksberg, Denmark, 1958 | |
| Principal Investigator: | Lotte Lauritzen, ph.d. | University of Copenhagen |
More Information
| Responsible Party: | Dept. of Human Nutrition, University of Copenhagen ( Lotta Lauritzen ) |
| Study ID Numbers: | M187 |
| Study First Received: | March 8, 2007 |
| Last Updated: | August 12, 2008 |
| ClinicalTrials.gov Identifier: | NCT00445614 History of Changes |
| Health Authority: | Denmark: The Danish National Committee on Biomedical Research Ethics |
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nutrition cardiovascular risk inflammation vascular function |
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Healthy Inflammation |
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Cardiovascular Diseases |
