Clinical trial NCT02350595: A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight
Obesity
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: Bergen Medical Research Foundation
name: Skretting ASA
name: Leroy Seafood Group ASA
First posted: 2015-01-29
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in serum concentrations of glucose
timeFrame: baseline and 8 weeks
Secondary outcomes:
measure: 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.
timeFrame: baseline and 8 weeks
measure: Changes in serum vitamin concentrations after fish intake.
timeFrame: baseline and 8 weeks
measure: Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake.
timeFrame: baseline and 8 weeks
measure: Changes in fecal microbiota profile after fish intake.
timeFrame: baseline and 8 weeks
measure: Changes in fecal and serum concentrations of lipids and bile acids after fish intake.
timeFrame: baseline and 8 weeks
measure: Changes in markers of oxidative stress after fish intake.
timeFrame: baseline and 8 weeks
measure: Changes in total neopterin after fish intake
timeFrame: baseline and 8 weeks
measure: Quantification of markers of kidney dysfunction
timeFrame: baseline and 8 weeks
measure: Changes in amino acids and metabolites of amino acids after a standardized meal.
timeFrame: baseline
measure: Changes in metabolites and co-factors involved in one-carbon metabolism after a standardized meal
timeFrame: baseline
measure: Comparisons of amino acid concentrations in serum and urine between men and women
timeFrame: baseline
measure: Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine between men and women
timeFrame: baseline
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Haukeland University Hospital
Study officials:
References:
citation: Helland A, Bratlie M, Hagen IV, Mjos SA, Sornes 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 content in the leucocyte membrane in healthy overweight adults: a randomised trial. Br J Nutr. 2017 May;117(10):1368-1378. doi: 10.1017/S0007114517001234. Epub 2017 Jun 13.
citation: Helland A, Bratlie M, Hagen IV, Midttun O, 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/s00394-021-02497-0. Epub 2021 Feb 12.
citation: Bratlie M, Hagen IV, Helland A, Erchinger F, Midttun O, 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 acids in overweight adults: a randomised clinical trial. Eur J Nutr. 2021 Jun;60(4):2231-2248. doi: 10.1007/s00394-020-02417-8. Epub 2020 Oct 27.
citation: Bratlie M, Hagen IV, Helland A, Midttun O, 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 degrees north latitude: a randomised trial. Br J Nutr. 2020 Feb 28;123(4):419-427. doi: 10.1017/S0007114519002964. Epub 2019 Nov 25.
citation: Hagen IV, Helland A, Bratlie M, Midttun O, 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 adults with overweight or obesity. Eur J Nutr. 2020 Aug;59(5):2249-2259. doi: 10.1007/s00394-019-02076-4. Epub 2019 Aug 10.