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

Obesity Clinical Trial

— 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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02350595
• Other study ID #: FISK2
• Status: Completed
• Phase: N/A
• Start date: August 2011
• Est. completion date: December 2012

Study information

• Verified date: December 2021
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Overweight

Intervention

Other:
• Lean fish

• Fatty fish

Locations

Country	Name	City	State
Norway	Haukeland University Hospital	Bergen

Sponsors (4)

Lead Sponsor	Collaborator
University of Bergen	Bergen Medical Research Foundation, Leroy Seafood Group ASA, Skretting ASA

Country where clinical trial is conducted

Norway, 

References & Publications (5)

Bratlie M, Hagen IV, Helland A, Erchinger F, Midttun Ø, 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 a — View Citation

Bratlie M, Hagen IV, Helland A, Midttun Ø, 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° north latitude: a randomised tr — View Citation

Hagen IV, Helland A, Bratlie M, Midttun Ø, 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 ad — View Citation

Helland A, Bratlie M, Hagen IV, Midttun Ø, 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/s003 — View Citation

Helland A, Bratlie M, Hagen IV, Mjøs SA, Sørnes 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 co — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in serum concentrations of glucose		baseline and 8 weeks
Secondary	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
Secondary	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.	baseline and 8 weeks
Secondary	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	baseline and 8 weeks
Secondary	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)	baseline and 8 weeks
Secondary	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.	baseline and 8 weeks
Secondary	Changes in markers of oxidative stress after fish intake.	Antioxidant enzymes, antioxidant enzyme cofactors and biomarkers of oxidative stress were quantified in serum	baseline and 8 weeks
Secondary	Changes in total neopterin after fish intake	Total neopterin was measured in serum.	baseline and 8 weeks
Secondary	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	baseline and 8 weeks
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	baseline
Secondary	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	baseline