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

NCT02350595 | Completed

• 1 other identifier: FISK2
• Study Type: interventional
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Overweight; Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in serum concentrations of glucose

  baseline and 8 weeks

Secondary Outcomes (12)

• 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 vitamin concentrations after fish intake.

  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

• Changes in fecal microbiota profile after fish intake.

  baseline and 8 weeks

• Changes in fecal and serum concentrations of lipids and bile acids after fish intake.

  baseline and 8 weeks

Study Arms (3)

Lean fish

EXPERIMENTAL

Participants eat 750g of lean fish per week for 8 weeks.

Other: Lean fish

Fatty fish

EXPERIMENTAL

Participants eat 750g of fatty fish per week for 8 weeks.

Other: Fatty fish

Control

NO INTERVENTION

Participants eat as normal, but avoid fish and seafood for 8 weeks.

Interventions

Lean fish OTHER

Lean fish

Fatty fish OTHER

Fatty fish

Eligibility Criteria

• Age: 18 Years - 69 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• BMI ≥27 kg/m2
• fasting blood glucose ≤7.0 mmol/L

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Bergen: lead
• Bergen Medical Research Foundation: collaborator
• Skretting ASA: collaborator
• Leroy Seafood Group ASA: collaborator

Study Sites (1)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Related Publications (6)

• 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.

  PMID: 28606215 RESULT

• 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.

  PMID: 33576844 RESULT

• 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.

  PMID: 33108521 RESULT

• 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.

  PMID: 31760958 RESULT

• 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.

  PMID: 31401679 RESULT

• Hagen IV, Helland A, Bratlie M, Midttun O, McCann A, Ulvik A, Mellgren G, Ueland PM, Gudbrandsen OA. Serum concentrations of amino acids and tryptophan metabolites are affected by consumption of a light breakfast: a clinical intervention study in adults with overweight or obesity. BMC Nutr. 2023 Jan 11;9(1):10. doi: 10.1186/s40795-022-00661-1.

  PMID: 36631895 DERIVED

MeSH Terms

Conditions

Overweight; Obesity

Interventions

bearberry, bladderwrack, borage oil, centella, fatty acid, fish oil, ginkgo biloba, melilotus, soya lecithin drug combination

Condition Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher

Study Record Dates

• First Submitted: January 26, 2015
• First Posted: January 29, 2015
• Study Start: August 1, 2011
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: January 14, 2022

Record last verified: 2021-12

Locations

NO (1)