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Completed

NCT Number: NCT02350595

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

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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Haukeland University Hospital

Bergen, 5021, Norway

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Lean fish

Other

Fatty fish

Other

Primary outcomes

  1. Changes in serum concentrations of glucose

    Time frame: baseline and 8 weeks

Secondary outcomes

  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.

    Time frame: baseline and 8 weeks

  2. 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.

  3. 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

  4. 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)

  5. 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.

  6. 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

  7. Changes in total neopterin after fish intake

    Time frame: baseline and 8 weeks

    Total neopterin was measured in serum.

  8. 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

  9. 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

  10. 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

  11. 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

  12. 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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

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

Registry information

Official study 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.

Acronym: FISK2

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jan 29, 2015
Registry last updated
Jan 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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