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

• Sponsor: University of Bergen (Other)
• Overall Status: Completed
• CT.gov ID: NCT02350595
• Collaborator: Bergen Medical Research Foundation (Other), Skretting ASA (Other), Leroy Seafood Group ASA (Industry)
• Enrollment: 76
• Location: 1
• Arms: 3
• Duration (Months): 16
• Patients Per Site Per Month: 4.7

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Overweight; Obesity	Other: Lean fish; Other: Fatty fish	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 76 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2011
• Actual Primary Completion Date: Dec 1, 2012
• Actual Study Completion Date: Dec 1, 2012

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Changes in serum concentrations of glucose [baseline and 8 weeks]

Secondary Outcome Measures

1. 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. [baseline and 8 weeks]

2. Changes in serum vitamin concentrations after fish intake. [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.

3. Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake. [baseline and 8 weeks]

   Concentrations of amino acids and amino acid metabolites were measured in fasting serum and morning urine

4. Changes in fecal microbiota profile after fish intake. [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)

5. Changes in fecal and serum concentrations of lipids and bile acids after fish intake. [baseline and 8 weeks]

   Fat, cholesterol and total bile acids were quantified in feces (72h collection) and fasting serum.

6. Changes in markers of oxidative stress after fish intake. [baseline and 8 weeks]

   Antioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in serum

7. Changes in total neopterin after fish intake [baseline and 8 weeks]

   Total neopterin was measured in serum.

8. Quantification of markers of kidney dysfunction [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

9. Changes in amino acids and metabolites of amino acids after a standardized meal. [baseline]

   Concentrations of amino acids and amino acid metabolites were measured in fasting and postprandial serum

10. Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal [baseline]

    Concentrations of relevant metabolites and co-factors were measured in fasting and postprandial serum

11. Comparisons of amino acid concentrations in serum and urine between men and women [baseline]

    Concentrations of amino acids and amino acid metabolites were measured in serum and urine

12. Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women [baseline]

    Concentrations of relevant metabolites and co-factors were measured in serum and urine

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 69 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Haukeland University Hospital	Bergen		Norway	5021

Sponsors and Collaborators

• University of Bergen
• Bergen Medical Research Foundation
• Skretting ASA
• Leroy Seafood Group ASA

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Oddrun Anita Gudbrandsen, Researcher, University of Bergen
• ClinicalTrials.gov Identifier: NCT02350595
• Other Study ID Numbers: FISK2
• First Posted: Jan 29, 2015
• Last Update Posted: Jan 14, 2022
• Last Verified: Dec 1, 2021

• Additional relevant MeSH terms: Overweight

Study Results

No Results Posted as of Jan 14, 2022