Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
Primary Purpose
Cardiovascular Diseases, Metabolic Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Intake of rainbow trout from different feeding conditions versus a control poultry meal
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Diseases focused on measuring Cardiovascular Heart Disease
Eligibility 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
Sites / Locations
- Institute of Human Nutrition, University of Copenhagen
Outcomes
Primary Outcome Measures
plasma protein expression
Blood Pressure
Pulse Wave Analysis
Pulse wave Velocity
Secondary Outcome Measures
Plasma Triglycerides
Full Information
NCT ID
NCT00432952
First Posted
February 7, 2007
Last Updated
August 12, 2008
Sponsor
University of Copenhagen
Collaborators
Danish Institute of Fisheries Research
1. Study Identification
Unique Protocol Identification Number
NCT00432952
Brief Title
Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
Study Type
Interventional
2. Study Status
Record Verification Date
August 2008
Overall Recruitment Status
Unknown status
Study Start Date
January 2007 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
January 2009 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
University of Copenhagen
Collaborators
Danish Institute of Fisheries Research
4. Oversight
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Diseases, Metabolic Syndrome
Keywords
Cardiovascular Heart Disease
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Single
Allocation
Randomized
Enrollment
6 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Intake of rainbow trout from different feeding conditions versus a control poultry meal
Primary Outcome Measure Information:
Title
plasma protein expression
Title
Blood Pressure
Title
Pulse Wave Analysis
Title
Pulse wave Velocity
Secondary Outcome Measure Information:
Title
Plasma Triglycerides
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lotte Lauritzen, Ph.D
Organizational Affiliation
University of Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute of Human Nutrition, University of Copenhagen
City
Frederiksberg C
ZIP/Postal Code
1958
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
25622825
Citation
Rentsch ML, Lametsch R, Bugel S, Jessen F, Lauritzen L. The effects of eating marine- or vegetable-fed farmed trout on the human plasma proteome profiles of healthy men. Br J Nutr. 2015 Feb 28;113(4):699-707. doi: 10.1017/S0007114514004152. Epub 2015 Jan 27.
Results Reference
derived
Learn more about this trial
Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
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