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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2008 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00432952
First Posted: February 8, 2007
Last Update Posted: August 13, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Danish Institute of Fisheries Research
Information provided by:
University of Copenhagen
  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
Intervention Model: Crossover Assignment
Masking: Single
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

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Senior)
Sexes 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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Investigators
Principal Investigator: Lotte Lauritzen, Ph.D University of Copenhagen
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Associate profesor Lotte lauritzen, Dept. of Human Nutrtion
ClinicalTrials.gov Identifier: NCT00432952     History of Changes
Other Study ID Numbers: M186
First Submitted: February 7, 2007
First Posted: February 8, 2007
Last Update Posted: August 13, 2008
Last Verified: August 2008

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