Clinical trial NCT00432952: Acute Single Meal Effects of Trout on Cardiovascular Risk Markers and Plasma Proteome
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Cardiovascular Diseases
Metabolic Syndrome
Keywords: Cardiovascular Heart Disease
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
Collaborators: name: Danish Institute of Fisheries Research
First posted: 2007-02-08
Enrollment: 6
Sex: MALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: plasma protein expression
measure: Blood Pressure
measure: Pulse Wave Analysis
measure: Pulse wave Velocity
Secondary outcomes:
measure: Plasma Triglycerides
Other outcomes:
Locations:
city: Frederiksberg C
country: Denmark
facility: Institute of Human Nutrition, University of Copenhagen
Study officials:
affiliation: University of Copenhagen
name: Lotte Lauritzen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
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.