Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome

August 12, 2008 updated by: University of Copenhagen

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

In a controlled, single blinded human single meal study 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. 6 healthy men, age 40-70, will be randomized to trout fed on only vegetable, only marine and a mix of different compositions of vegetable and marine feeds. Outcome variables are blood pressure, pulse wave analyse, pulse wave velocity, plasma protein profile, and plasma triglycerides.

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.

Study Type

Interventional

Enrollment

6

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Frederiksberg C, Denmark, 1958
        • Institute of Human Nutrition, University of Copenhagen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

What is the study measuring?

Primary Outcome Measures

Outcome Measure
plasma protein expression
Blood Pressure
Pulse Wave Analysis
Pulse wave Velocity

Secondary Outcome Measures

Outcome Measure
Plasma Triglycerides

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Copenhagen

Collaborators

Danish Institute of Fisheries Research

Investigators

  • Principal Investigator: Lotte Lauritzen, Ph.D, University of Copenhagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2007

Primary Completion (Actual)

March 1, 2007

Study Completion (Anticipated)

January 1, 2009

Study Registration Dates

First Submitted

February 7, 2007

First Submitted That Met QC Criteria

February 7, 2007

First Posted (Estimate)

February 8, 2007

Study Record Updates

Last Update Posted (Estimate)

August 13, 2008

Last Update Submitted That Met QC Criteria

August 12, 2008

Last Verified

August 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M186

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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