A Study on the Possible Health Effects of Lean Fish, Fatt... | NCT02130908

Studies
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults

NCT02130908

Sponsor

University of Bergen

Status

Completed

Last Update Posted

May 2, 2018Actual

Enrollment

45Actual

Phase

Not Applicable

Conditions

Metabolic Disorders
Obesity

Interventions

Lean fish
Fatty fish
Lean meat

Countries

Norway

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

May 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2011

Primary Completion Date

Jul 2015Actual

Completion Date

Jul 2015Actual

First Submitted Date

May 1, 2014

First Submission Date that Met QC Criteria

May 5, 2014

First Posted Date

May 6, 2014Estimated

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

May 1, 2018

Last Update Posted Date

May 2, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Oddrun Anita Gudbrandsen, Researcher, University of BergenPrincipal Investigator

Lead Sponsor

University of BergenOTHER

Collaborators

Name	Class
Bergen Medical Research Foundation	OTHER
Skretting ASA	UNKNOWN
Leroy Seafood Group ASA	INDUSTRY

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This study is a pilot study to investigate whether intake of lean or fatty fish, or lean meat would affect parameters related to health in healthy non-obese adults, and will serve as basis for future calculation of group sizes in coming studies. Participants consumed 750g/week of fillets of fish or meat for 4 weeks.

Hypothesis:

High intake of either lean or fatty fish will not affect serum concentrations of lipids and inflammatory markers as well as improve glucose tolerance during the 4 week intervention period when compared to lean meat intake.

Detailed Description

Not provided

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

45Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Lean fish	Experimental	Other: Lean fish
Fatty fish	Experimental	Other: Fatty fish
Lean meat	Experimental	Other: Lean meat

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lean fish	Other	Participants consumed 150g of lean fish, five times per week for 4 weeks	Lean fish

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum		Endpoint after 4 weeks intervention

Secondary Outcomes

Measure	Description	Time Frame
Changes in body weight		Endpoint after 4 weeks intervention

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

adults
non-obese
healthy

Exclusion Criteria:

diabetes
diagnosed diseases of the intestine or cardiovacular system

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Haukeland University Hospital		Bergen		5021	Norway

Condition Browse Module

MeSH Terms

ID	Term
D008659	Metabolic Diseases
D009765	Obesity

Ancestor Terms

ID	Term
D009750	Nutritional and Metabolic Diseases
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C119572	bearberry, bladderwrack, borage oil, centella, fatty acid, fish oil, ginkgo biloba, melilotus, soya lecithin drug combination

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided