Acute Single Meal Effects of Trout on Cardiovascular Risk... | NCT00432952

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

NCT00432952

Sponsor

University of Copenhagen

Status

Unknown status

Last Update Posted

Aug 13, 2008Estimated

Enrollment

Phase

Not Applicable

Conditions

Cardiovascular Diseases
Metabolic Syndrome

Interventions

Intake of rainbow trout from different feeding conditions versus a control poultry meal

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2008

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2007

Primary Completion Date

Mar 2007Actual

Completion Date

Jan 2009Estimated

First Submitted Date

Feb 7, 2007

First Submission Date that Met QC Criteria

Feb 7, 2007

First Posted Date

Feb 8, 2007Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 12, 2008

Last Update Posted Date

Aug 13, 2008Estimated

Name	Class
Danish Institute of Fisheries Research	OTHER

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Intake of rainbow trout from different feeding conditions versus a control poultry meal	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
plasma protein expression
Blood Pressure
Pulse Wave Analysis
Pulse wave Velocity

Secondary Outcomes

Measure	Description	Time Frame
Plasma Triglycerides

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Lotte Lauritzen, Ph.D	University of Copenhagen	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Institute of Human Nutrition, University of Copenhagen		Frederiksberg C		1958	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
25622825	Derived	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.

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases