NCT00445614

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
72

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2007

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2007

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

March 8, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 9, 2007

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2007

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2007

Completed
Last Updated

August 14, 2008

Status Verified

August 1, 2008

Enrollment Period

9 months

First QC Date

March 8, 2007

Last Update Submit

August 12, 2008

Conditions

Keywords

nutritioncardiovascular riskinflammationvascular function

Outcome Measures

Primary Outcomes (7)

  • plasma protein expression

  • blood pressure

  • pulse wave analysis

  • pulse wave velocity

  • cardiovascular risk markers

  • markers of inflammation

  • plasma lipids

Study Arms (3)

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

OTHER

150 g/d of poultry (for comparison)

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

Interventions

Marine troutPoultryVegetable trout

Eligibility Criteria

Age40 Years - 70 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 40-70
  • Body mass index 18,5 - 30

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Human Nutrition, Denmark

Frederiksberg, Frederiksberg, 1958, Denmark

Location

MeSH Terms

Conditions

Cardiovascular DiseasesInflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Lotte Lauritzen, ph.d.

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2007

First Posted

March 9, 2007

Study Start

March 1, 2007

Primary Completion

December 1, 2007

Study Completion

December 1, 2007

Last Updated

August 14, 2008

Record last verified: 2008-08

Locations