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Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
This study is ongoing, but not recruiting participants.
First Received: February 7, 2007   Last Updated: August 12, 2008   History of Changes
Sponsors and Collaborators: University of Copenhagen
Danish Institute of Fisheries Research, Denmark
Information provided by: University of Copenhagen
ClinicalTrials.gov Identifier: NCT00432952
  Purpose

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.


Condition Intervention
Cardiovascular Diseases
Metabolic Syndrome
Behavioral: Intake of rainbow trout from different feeding conditions versus a control poultry meal

Study Type: Interventional
Study Design: Prevention, Randomized, Single Blind, Active Control, Crossover Assignment, Bio-availability Study

Further study details as provided by University of Copenhagen:

Primary Outcome Measures:
  • plasma protein expression
  • Blood Pressure
  • Pulse Wave Analysis
  • Pulse wave Velocity

Secondary Outcome Measures:
  • Plasma Triglycerides

Estimated Enrollment: 6
Study Start Date: January 2007
Estimated Study Completion Date: January 2009
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00432952

Locations
Denmark
Institute of Human Nutrition, University of Copenhagen
Frederiksberg C, Denmark, 1958
Sponsors and Collaborators
University of Copenhagen
Danish Institute of Fisheries Research, Denmark
Investigators
Principal Investigator: Lotte Lauritzen, Ph.D University of Copenhagen
  More Information

No publications provided

Responsible Party: Dept. of Human Nutrtion ( Associate profesor Lotte lauritzen )
Study ID Numbers: M186
Study First Received: February 7, 2007
Last Updated: August 12, 2008
ClinicalTrials.gov Identifier: NCT00432952     History of Changes
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by University of Copenhagen:
Cardiovascular Heart Disease

Study placed in the following topic categories:
Heart Diseases

Additional relevant MeSH terms:
Pathologic Processes
Disease
Syndrome
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 02, 2009