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

• Register: ClinicalTrials.gov
• Last refreshed on: 24 August 2021
• Main ID: NCT02350595
• Date of registration: 26/01/2015
• Prospective Registration: No
• Primary sponsor: University of Bergen
• Public title: A Study on the Possible Health Effects of Lean Fish and Fatty Fish Intake in Overweight or Obese Adults FISK2
• Scientific 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.
• Date of first enrolment: August 2011
• Target sample size: 76
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02350595
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Outcomes Assessor).
• Phase: N/A

Countries of recruitment

Norway

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: 69 Years
Gender: All

Health Condition(s) or Problem(s) studied

Obesity

Overweight

Intervention(s)

Other: Fatty fish

Other: Lean fish

Primary Outcome(s)

Changes in serum concentrations of glucose [Time Frame: baseline and 8 weeks]

Secondary Outcome(s)

Changes in serum and urine concentrations of amino acids and metabolites of amino acids after fish intake. [Time Frame: baseline and 8 weeks]

Changes in serum vitamin concentrations after fish intake. [Time Frame: baseline and 8 weeks]

Changes in fecal microbiota profile after fish intake. [Time Frame: baseline and 8 weeks]

Changes in amino acids and metabolites of amino acids after a standardized meal. [Time Frame: baseline]

Changes in markers of oxidative stress after fish intake. [Time Frame: baseline and 8 weeks]

Changes in fecal and serum concentrations of lipids and bile acids after fish intake. [Time Frame: baseline and 8 weeks]

Changes in total neopterin after fish intake [Time Frame: baseline and 8 weeks]

Quantification of markers of kidney dysfunction [Time Frame: baseline and 8 weeks]

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]

Secondary ID(s)

FISK2

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Leroy Seafood Group ASA

Bergen Medical Research Foundation

Skretting ASA