Health Effects of Salmon Fishmeal in Humans (FishMeal)

Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance

Diabetes contributes significantly to the burden of disease in Norway and cardiovascular disease is the main cause of mortality.

Both lean and fatty fish are shown to have beneficial health effects. In addition to omega-3 fatty acids, fish contain potential health-promoting components such as taurine, vitamin D, vitamin B12, iodine, selenium and more unspecified components such as bioactive peptides. With the expected growth in the aquaculture sector, more protein-rich by-products will become available.

The overall aim of this project is to investigate the health beneficial effects of fish protein in the form of salmon fishmeal in a human intervention study with regard to metabolic risk markers.

We will include subjects with impaired glucose tolerance to a randomized controlled parallel study. The subjects will receive capsules with fishmeal or placebo.

Study Overview

• Status: Completed
• Conditions: Impaired Glucose Tolerance
• Intervention / Treatment: Dietary supplement: Salmon fishmeal; Dietary supplement: Microcrystalline cellulose

• Study Type: Interventional
• Enrollment (Actual): 88
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Post Box 1046, Blindern
    • Oslo, Post Box 1046, Blindern, Norway, 0317
      • University of Oslo

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fasting plasma glucose ≥ 5.6 mmol/l or
• Plasma glucose ≥ 6.5 mmol/l 2h after an OGTT or
• HbA1c ≥ 5.8 %

Exclusion criteria:

• Diabetes (defined as p-glucose ≥ 7.0 mmol/l p-glucose ≥11,1 mmol/l 2h after OGTT or HbA1c ≥ 6.5 %)
• High fish intake (> 450 gram/week) or fish allergy
• Age-related elevated blood pressure (≥ 70 år: ≥ 180/110 mmHg, > 40-70: ≥ 170/100 mmHg and ≤ 40 år: ≥ 160/100 mmHg)
• Use of prescription medicines related to diabetes, inflammation, systemic use of corticosteroids.
• Non-stable use of lipid lowering drugs, thyroxine, blood pressure lowering drugs, drugs affecting appetite, dietary supplements (including n-3)
• High intake of protein supplements powder
• Pregnancy
• Planning pregnancy or changes in body weight

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Salmon fishmeal; 7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks	Dietary supplement: Salmon fishmeal; Salmon fishmeal with high protein content; Other Names: Fish protein
PLACEBO_COMPARATOR: Microcrystalline cellulose; 7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks	Dietary supplement: Microcrystalline cellulose; Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.; Other Names: Cellulose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2 hour postprandial blood glucose concentration	Glucose concentration measured before and after a standard glucose tolerance test at baseline and after 8 weeks	Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
Fasting blood glucose concentration	Measured at baseline and after 8 weeks.	Change in blood glucose concentration from baseline and after 8 weeks between groups

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood concentration of insulin	Blood concentration measured fasting and 2 hours after an oral glucose tolerance test	Changes in blood insulin concentration from baseline and after 8 weeks between groups
HOMA-IR	Blood concentration of insulin x blood concentration of glucose will be used to calculate HOMAR-IR fasting and 2 hours after an oral glucose tolerance test	Changes in HOMAR-IR from baseline and after 8 weeks between groups
Blood concentration of HbA1c	Blood concentration measured fasting	Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Blood concentration of incretins (i.e. GLP-1)	Blood concentration of incretins measured fasting and 2 hours after oral glucose tolerance test	Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Markers related to lipid metabolism	Blood concentrations of i.e. triglycerides, total-, LDL- and HDL- cholesterol, free fatty acids and lipoprotein subclasses (lipidomics)	Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon
Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation	Blood concentrations of i.e. CRP, IL-6	Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups
Markers related to appetite	Blood concentrations of gut hormones, i.e. PYY, amylin, leptin	Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups
Changes in PBMC wholegenome transcriptome and untargeted metabolomics	Blood or urine transcriptome and metabolomics	Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups
Changes in markers related to gut microbiota	Faecal short-chain fatty acids, bacteria type and diversity	Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon
Changes in blood concentration of micronutrients related to fishintake	Blood concentrations of i.e. vitamin D, Zn, Se and iodine	Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon
Changes in blood concentration of amino acids	Blood concentrations of different aminoacids such as i.e valine, isoleucine, leucine	Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention
Body weight	Bodyweight (kg) will be used to calculate i.e BMI (kg/m2)	Change between groups from baseline and after 8 weeks intervensjon will be calculated
Height	Height (m) will be used to calculate i.e. BMI (kg/m2)	Change between groups from baseline and after 8 weeks intervensjon will be calculated

Collaborators and Investigators

• Sponsor: University of Oslo
• Investigators: Principal Investigator: Kirsten Holven, Professor, University of Oslo

Publications and helpful links

General Publications

• Hustad KS, Ottestad I, Olsen T, Saether T, Ulven SM, Holven KB. Salmon fish protein supplement increases serum vitamin B12 and selenium concentrations: secondary analysis of a randomised controlled trial. Eur J Nutr. 2022 Sep;61(6):3085-3093. doi: 10.1007/s00394-022-02857-4. Epub 2022 Apr 1.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 14, 2018
• Primary Completion (ACTUAL): November 1, 2019
• Study Completion (ACTUAL): November 1, 2019

Study Registration Dates

• First Submitted: June 29, 2018
• First Submitted That Met QC Criteria: December 3, 2018
• First Posted (ACTUAL): December 5, 2018

Study Record Updates

• Last Update Posted (ACTUAL): September 28, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperglycemia; Glucose Intolerance
• Other Study ID Numbers: 901420

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No