search
Back to results

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

Primary Purpose

Overweight, Obesity

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

About this trial

This is an interventional treatment trial for Overweight

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Haukeland University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

No Intervention

Arm Label

Lean fish

Fatty fish

Control

Arm Description

Participants eat 750g of lean fish per week for 8 weeks.

Participants eat 750g of fatty fish per week for 8 weeks.

Participants eat as normal, but avoid fish and seafood for 8 weeks.

Outcomes

Primary Outcome Measures

Changes in serum concentrations of glucose

Secondary Outcome Measures

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.
Changes in serum vitamin concentrations after fish intake.
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.
Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake.
Concentrations of amino acids and amino acid metabolites were measured in fasting serum and morning urine
Changes in fecal microbiota profile after fish intake.
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)
Changes in fecal and serum concentrations of lipids and bile acids after fish intake.
Fat, cholesterol and total bile acids were quantified in feces (72h collection) and fasting serum.
Changes in markers of oxidative stress after fish intake.
Antioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in serum
Changes in total neopterin after fish intake
Total neopterin was measured in serum.
Quantification of markers of kidney dysfunction
Urine concentrations of cystatin C and T-cell immunoglobulin mucin-1 (relative to creatinine) were measured as markers of kidney function
Changes in amino acids and metabolites of amino acids after a standardized meal.
Concentrations of amino acids and amino acid metabolites were measured in fasting and postprandial serum
Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal
Concentrations of relevant metabolites and co-factors were measured in fasting and postprandial serum
Comparisons of amino acid concentrations in serum and urine between men and women
Concentrations of amino acids and amino acid metabolites were measured in serum and urine
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women
Concentrations of relevant metabolites and co-factors were measured in serum and urine

Full Information

First Posted
January 26, 2015
Last Updated
December 29, 2021
Sponsor
University of Bergen
Collaborators
Bergen Medical Research Foundation, Skretting ASA, Leroy Seafood Group ASA
search

1. Study Identification

Unique Protocol Identification Number
NCT02350595
Brief Title
A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults
Acronym
FISK2
Official Title
Fiskespisestudiene 2011-2014. Spiseforsøk Med Fisk. Delstudie 2: Studie av Mulige Effekter av Fet og Mager Fisk på Glukosemetabolismen og inflammasjonsmarkører i Overvektige Voksne.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
August 2011 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (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
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.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
76 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Lean fish
Arm Type
Experimental
Arm Description
Participants eat 750g of lean fish per week for 8 weeks.
Arm Title
Fatty fish
Arm Type
Experimental
Arm Description
Participants eat 750g of fatty fish per week for 8 weeks.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Participants eat as normal, but avoid fish and seafood for 8 weeks.
Intervention Type
Other
Intervention Name(s)
Lean fish
Intervention Type
Other
Intervention Name(s)
Fatty fish
Primary Outcome Measure Information:
Title
Changes in serum concentrations of glucose
Time Frame
baseline and 8 weeks
Secondary Outcome Measure Information:
Title
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
Title
Changes in serum vitamin concentrations after fish intake.
Description
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.
Time Frame
baseline and 8 weeks
Title
Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake.
Description
Concentrations of amino acids and amino acid metabolites were measured in fasting serum and morning urine
Time Frame
baseline and 8 weeks
Title
Changes in fecal microbiota profile after fish intake.
Description
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)
Time Frame
baseline and 8 weeks
Title
Changes in fecal and serum concentrations of lipids and bile acids after fish intake.
Description
Fat, cholesterol and total bile acids were quantified in feces (72h collection) and fasting serum.
Time Frame
baseline and 8 weeks
Title
Changes in markers of oxidative stress after fish intake.
Description
Antioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in serum
Time Frame
baseline and 8 weeks
Title
Changes in total neopterin after fish intake
Description
Total neopterin was measured in serum.
Time Frame
baseline and 8 weeks
Title
Quantification of markers of kidney dysfunction
Description
Urine concentrations of cystatin C and T-cell immunoglobulin mucin-1 (relative to creatinine) were measured as markers of kidney function
Time Frame
baseline and 8 weeks
Title
Changes in amino acids and metabolites of amino acids after a standardized meal.
Description
Concentrations of amino acids and amino acid metabolites were measured in fasting and postprandial serum
Time Frame
baseline
Title
Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal
Description
Concentrations of relevant metabolites and co-factors were measured in fasting and postprandial serum
Time Frame
baseline
Title
Comparisons of amino acid concentrations in serum and urine between men and women
Description
Concentrations of amino acids and amino acid metabolites were measured in serum and urine
Time Frame
baseline
Title
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women
Description
Concentrations of relevant metabolites and co-factors were measured in serum and urine
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Haukeland University Hospital
City
Bergen
ZIP/Postal Code
5021
Country
Norway

12. IPD Sharing Statement

Citations:
PubMed Identifier
28606215
Citation
Helland A, Bratlie M, Hagen IV, Mjos SA, Sornes S, Ingvar Halstensen A, Brokstad KA, Sveier H, Rosenlund G, Mellgren G, Gudbrandsen OA. High intake of fatty fish, but not of lean fish, improved postprandial glucose regulation and increased the n-3 PUFA content in the leucocyte membrane in healthy overweight adults: a randomised trial. Br J Nutr. 2017 May;117(10):1368-1378. doi: 10.1017/S0007114517001234. Epub 2017 Jun 13.
Results Reference
result
PubMed Identifier
33576844
Citation
Helland A, Bratlie M, Hagen IV, Midttun O, Sveier H, Mellgren G, Ueland PM, Gudbrandsen OA. Effect of high intake of cod or salmon on serum total neopterin concentration: a randomised clinical trial. Eur J Nutr. 2021 Sep;60(6):3237-3248. doi: 10.1007/s00394-021-02497-0. Epub 2021 Feb 12.
Results Reference
result
PubMed Identifier
33108521
Citation
Bratlie M, Hagen IV, Helland A, Erchinger F, Midttun O, Ueland PM, Rosenlund G, Sveier H, Mellgren G, Hausken T, Gudbrandsen OA. Effects of high intake of cod or salmon on gut microbiota profile, faecal output and serum concentrations of lipids and bile acids in overweight adults: a randomised clinical trial. Eur J Nutr. 2021 Jun;60(4):2231-2248. doi: 10.1007/s00394-020-02417-8. Epub 2020 Oct 27.
Results Reference
result
PubMed Identifier
31760958
Citation
Bratlie M, Hagen IV, Helland A, Midttun O, Ulvik A, Rosenlund G, Sveier H, Mellgren G, Ueland PM, Gudbrandsen OA. Five salmon dinners per week were not sufficient to prevent the reduction in serum vitamin D in autumn at 60 degrees north latitude: a randomised trial. Br J Nutr. 2020 Feb 28;123(4):419-427. doi: 10.1017/S0007114519002964. Epub 2019 Nov 25.
Results Reference
result
PubMed Identifier
31401679
Citation
Hagen IV, Helland A, Bratlie M, Midttun O, McCann A, Sveier H, Rosenlund G, Mellgren G, Ueland PM, Gudbrandsen OA. TMAO, creatine and 1-methylhistidine in serum and urine are potential biomarkers of cod and salmon intake: a randomised clinical trial in adults with overweight or obesity. Eur J Nutr. 2020 Aug;59(5):2249-2259. doi: 10.1007/s00394-019-02076-4. Epub 2019 Aug 10.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs