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

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ClinicalTrials.gov Identifier: NCT00432952
Recruitment Status : Unknown
Verified August 2008 by University of Copenhagen.
Recruitment status was:  Active, not recruiting
First Posted : February 8, 2007
Last Update Posted : August 13, 2008
Sponsor:
Collaborator:
Danish Institute of Fisheries Research
Information provided by:
University of Copenhagen

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.


Condition or disease Intervention/treatment Phase
Cardiovascular Diseases Metabolic Syndrome Behavioral: Intake of rainbow trout from different feeding conditions versus a control poultry meal Not Applicable

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  (Clinical Trial)
Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single
Primary Purpose: Prevention
Study Start Date : January 2007
Actual Primary Completion Date : March 2007
Estimated Study Completion Date : January 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources




Primary Outcome Measures :
  1. plasma protein expression
  2. Blood Pressure
  3. Pulse Wave Analysis
  4. Pulse wave Velocity

Secondary Outcome Measures :
  1. Plasma Triglycerides


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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

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

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 Posted: February 8, 2007    Key Record Dates
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