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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02350595
Acronym
FISK2
Enrollment
76
Registered
2015-01-29
Start date
2011-08-31
Completion date
2012-12-31
Last updated
2022-01-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Overweight, Obesity

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.

Interventions

Sponsors

Bergen Medical Research Foundation
CollaboratorOTHER
Skretting ASA
CollaboratorUNKNOWN
Leroy Seafood Group ASA
CollaboratorINDUSTRY
University of Bergen
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 69 Years
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

Design outcomes

Primary

MeasureTime frame
Changes in serum concentrations of glucosebaseline and 8 weeks

Secondary

MeasureTime frameDescription
Changes in serum vitamin concentrations after fish intake.baseline and 8 weeksSerum 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.baseline and 8 weeksConcentrations 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 weeks54 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 weeksFat, cholesterol and total bile acids were quantified in feces (72h collection) and fasting serum.
Changes in markers of oxidative stress after fish intake.baseline and 8 weeksAntioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in 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
Quantification of markers of kidney dysfunctionbaseline and 8 weeksUrine 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.baselineConcentrations 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 mealbaselineConcentrations 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 womenbaselineConcentrations 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 womenbaselineConcentrations of relevant metabolites and co-factors were measured in serum and urine
Changes in total neopterin after fish intakebaseline and 8 weeksTotal neopterin was measured in serum.

Countries

Norway

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 24, 2026