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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2008 by University of Copenhagen.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Danish Institute of Fisheries Research, Denmark
Information provided by:
University of Copenhagen
ClinicalTrials.gov Identifier:
NCT00432952
First received: February 7, 2007
Last updated: August 12, 2008
Last verified: August 2008
  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: Allocation: Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Crossover Assignment
Masking: Single Blind
Primary Purpose: Prevention

Resource links provided by NLM:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Keywords provided by University of Copenhagen:
Cardiovascular Heart Disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Metabolic Syndrome X
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on August 27, 2014