NCT00432952

Brief Summary

The acute effects of farmed rainbow trout, fed by various feeds versus a control meal with poultry meat on cardiovascular risk markers and plasma protein expression are investigated. The hypotheses of the study are that if the feed are changed from a marine origin to primarily a vegetable origin the content of long chain n-3 poly unsaturated fatty acids (n-3 PUFA) will decrease in the meat and thus possibly result in a decreased effect on health. Furthermore, the feed of the trouts are also expected to give rise to differences in the human plasma protein profile and fatty acid composition after consumption, which could be associated with physiological effects.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for not_applicable cardiovascular-diseases

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 7, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 8, 2007

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2007

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
Last Updated

August 13, 2008

Status Verified

August 1, 2008

Enrollment Period

2 months

First QC Date

February 7, 2007

Last Update Submit

August 12, 2008

Conditions

Keywords

Cardiovascular Heart Disease

Outcome Measures

Primary Outcomes (4)

  • plasma protein expression

  • Blood Pressure

  • Pulse Wave Analysis

  • Pulse wave Velocity

Secondary Outcomes (1)

  • Plasma Triglycerides

Interventions

Eligibility Criteria

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

You may qualify if:

  • Non regular smokers
  • Body Mass Index (18.5-30 kg/m2)
  • Able to eat fish

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)

Institute of Human Nutrition, University of Copenhagen

Frederiksberg C, 1958, Denmark

Location

Related Publications (1)

  • Rentsch ML, Lametsch R, Bugel S, Jessen F, Lauritzen L. The effects of eating marine- or vegetable-fed farmed trout on the human plasma proteome profiles of healthy men. Br J Nutr. 2015 Feb 28;113(4):699-707. doi: 10.1017/S0007114514004152. Epub 2015 Jan 27.

MeSH Terms

Conditions

Cardiovascular DiseasesMetabolic Syndrome

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

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
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 7, 2007

First Posted

February 8, 2007

Study Start

January 1, 2007

Primary Completion

March 1, 2007

Study Completion

January 1, 2009

Last Updated

August 13, 2008

Record last verified: 2008-08

Locations