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

Not Applicable

Completed

• Conditions: Obesity; Overweight
• Interventions: Other: Fatty fish; Other: Lean fish

• Registration Number: NCT02350595
• Lead Sponsor: University of Bergen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Study First Submitted: 2015-01-26
• Study First Submitted QC: 2015-01-28
• Study First Posted: 2015-01-29
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-29
• Last Update Posted: 2022-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fatty fish	Fatty fish	Participants eat 750g of fatty fish per week for 8 weeks.
Lean fish	Lean fish	Participants eat 750g of lean fish per week for 8 weeks.

Primary Outcome Measures

Name	Time	Method
Changes in serum concentrations of glucose	baseline and 8 weeks

Secondary Outcome Measures

Name	Time	Method
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.
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
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
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
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
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
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
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)
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.
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
Changes in total neopterin after fish intake	baseline and 8 weeks	Total neopterin was measured in serum.
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

Trial Locations

Locations (1)

Haukeland University Hospital; 🇳🇴 Bergen, Norway