A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults (FISK2)

December 29, 2021 updated by: Oddrun Anita Gudbrandsen, University of Bergen

Fiskespisestudiene 2011-2014. Spiseforsøk Med Fisk. Delstudie 2: Studie av Mulige Effekter av Fet og Mager Fisk på Glukosemetabolismen og inflammasjonsmarkører i Overvektige Voksne.

The potential health effects of high intake of lean or fatty fish will be investigated in overweight or obese adults. Participants consume 750g/week of fillets of fish for 8 weeks.

Hypothesis:

High intake of fatty or lean fish will beneficially affect glucose regulation and the immune system.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

76

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway, 5021
        • Haukeland University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • BMI ≥27 kg/m2
  • fasting blood glucose ≤7.0 mmol/L

Exclusion Criteria:

  • pregnancy
  • incompatibility with fish consumption (allergies, intolerance and/or dislike)
  • diagnosed diabetes mellitus, heart disease or gastrointestinal diseases
  • use of medications affecting lipid metabolism or glucose homeostasis
  • use of anti-inflammatory medications
  • use of supplements containing long chain n-3 fatty acids
  • intentional weight loss
  • and large fluctuation in body weight (>3 kg) over the previous two months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Lean fish
Participants eat 750g of lean fish per week for 8 weeks.
Other: Lean fish
Experimental: Fatty fish
Participants eat 750g of fatty fish per week for 8 weeks.
Other: Fatty fish
No Intervention: Control
Participants eat as normal, but avoid fish and seafood for 8 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in serum concentrations of glucose
Time Frame: baseline and 8 weeks
baseline and 8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in insulin, insulin C-peptide, leukocyte fatty acids, leukocyte function, body weight and composition, and intake of energy and macronutrients within the groups over time.
Time Frame: baseline and 8 weeks
baseline and 8 weeks
Changes in serum vitamin concentrations after fish intake.
Time Frame: baseline and 8 weeks
Serum concentrations of fat-soluble and water-soluble vitamins were measured, and dietary intakes of vitamins were estimated based on reported food intake from 5-day food diaries.
baseline and 8 weeks
Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake.
Time Frame: baseline and 8 weeks
Concentrations of amino acids and amino acid metabolites were measured in fasting serum and morning urine
baseline and 8 weeks
Changes in fecal microbiota profile after fish intake.
Time Frame: baseline and 8 weeks
54 DNA bacterial markers targeting more than 300 bacteria based on their 16S rRNA sequence in seven variable regions were analysed in feces (72h collection)
baseline and 8 weeks
Changes in fecal and serum concentrations of lipids and bile acids after fish intake.
Time Frame: baseline and 8 weeks
Fat, cholesterol and total bile acids were quantified in feces (72h collection) and fasting serum.
baseline and 8 weeks
Changes in markers of oxidative stress after fish intake.
Time Frame: baseline and 8 weeks
Antioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in serum
baseline and 8 weeks
Changes in total neopterin after fish intake
Time Frame: baseline and 8 weeks
Total neopterin was measured in serum.
baseline and 8 weeks
Quantification of markers of kidney dysfunction
Time Frame: baseline and 8 weeks
Urine concentrations of cystatin C and T-cell immunoglobulin mucin-1 (relative to creatinine) were measured as markers of kidney function
baseline and 8 weeks
Changes in amino acids and metabolites of amino acids after a standardized meal.
Time Frame: baseline
Concentrations of amino acids and amino acid metabolites were measured in fasting and postprandial serum
baseline
Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal
Time Frame: baseline
Concentrations of relevant metabolites and co-factors were measured in fasting and postprandial serum
baseline
Comparisons of amino acid concentrations in serum and urine between men and women
Time Frame: baseline
Concentrations of amino acids and amino acid metabolites were measured in serum and urine
baseline
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women
Time Frame: baseline
Concentrations of relevant metabolites and co-factors were measured in serum and urine
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Bergen Medical Research Foundation
Skretting ASA
Leroy Seafood Group ASA

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

December 1, 2012

Study Completion (Actual)

December 1, 2012

Study Registration Dates

First Submitted

January 26, 2015

First Submitted That Met QC Criteria

January 28, 2015

First Posted (Estimate)

January 29, 2015

Study Record Updates

Last Update Posted (Actual)

January 14, 2022

Last Update Submitted That Met QC Criteria

December 29, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FISK2

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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