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A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults (FISK1)

Primary Purpose

Metabolic Disorders, Obesity

Status
Completed
Phase
Not Applicable
Locations
Norway
Study Type
Interventional
Intervention
Lean fish
Fatty fish
Lean meat
Sponsored by
University of Bergen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Metabolic Disorders

Eligibility Criteria

20 Years - 35 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • adults
  • non-obese
  • healthy

Exclusion Criteria:

  • diabetes
  • diagnosed diseases of the intestine or cardiovacular system

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

Lean fish

Fatty fish

Lean meat

Arm Description

Outcomes

Primary Outcome Measures

Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum

Secondary Outcome Measures

Changes in body weight

Full Information

First Posted
May 1, 2014
Last Updated
May 1, 2018
Sponsor
University of Bergen
Collaborators
Bergen Medical Research Foundation, Skretting ASA, Leroy Seafood Group ASA
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1. Study Identification

Unique Protocol Identification Number
NCT02130908
Brief Title
A Study on the Possible Health Effects of Lean Fish, Fatty Fish and Lean Meat Intake in Non-obese Adults
Acronym
FISK1
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
March 2011 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Bergen
Collaborators
Bergen Medical Research Foundation, Skretting ASA, Leroy Seafood Group ASA

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Disorders, Obesity

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean fish
Arm Type
Experimental
Arm Title
Fatty fish
Arm Type
Experimental
Arm Title
Lean meat
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Lean fish
Intervention Description
Participants consumed 150g of lean fish, five times per week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Fatty fish
Intervention Description
Participants consumed 150g of fatty fish, five times per week for 4 weeks
Intervention Type
Other
Intervention Name(s)
Lean meat
Intervention Description
Participants consumed 150g of lean meat, five times per week for 4 weeks
Primary Outcome Measure Information:
Title
Changes in metabolic parameters (lipids, glucose, inflammatory markers) measured in serum
Time Frame
Endpoint after 4 weeks intervention
Secondary Outcome Measure Information:
Title
Changes in body weight
Time Frame
Endpoint after 4 weeks intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: adults non-obese healthy Exclusion Criteria: diabetes diagnosed diseases of the intestine or cardiovacular system
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

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

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