Clinical trial NCT03764423: Health Effects of Salmon Fishmeal in Humans
Official title: Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Impaired Glucose Tolerance
Lead sponsor: University of Oslo
Sponsor class: OTHER
First posted: 2018-12-05
Enrollment: 88
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: 2 hour postprandial blood glucose concentration
timeFrame: Change in 2 hour blood glucose concentration from baseline and after 8 weeks between groups
measure: Fasting blood glucose concentration
timeFrame: Change in blood glucose concentration from baseline and after 8 weeks between groups
Secondary outcomes:
measure: Blood concentration of insulin
timeFrame: Changes in blood insulin concentration from baseline and after 8 weeks between groups
measure: HOMA-IR
timeFrame: Changes in HOMAR-IR from baseline and after 8 weeks between groups
measure: Blood concentration of HbA1c
timeFrame: Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
measure: Blood concentration of incretins (i.e. GLP-1)
timeFrame: Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups
Other outcomes:
measure: Markers related to lipid metabolism
timeFrame: Changes in blood concentrations of markers related to lipid metabolism from baseline and after 8 weeks intervensjon
measure: Markers related to low grade inflammation, including changes in genes expression level in peripheral blood mononuclear cell (PBMCs) in circulation
timeFrame: Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups
measure: Markers related to appetite
timeFrame: Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups
measure: Changes in PBMC wholegenome transcriptome and untargeted metabolomics
timeFrame: Changes in blood concentration of PBMC wholegenome transcriptome and untargeted metabolomics from baseline and after 8 weeks whithin and between groups
measure: Changes in markers related to gut microbiota
timeFrame: Changes in markers related to gut microbiota between groups from baseline and after 8 weeks intervensjon
measure: Changes in blood concentration of micronutrients related to fishintake
timeFrame: Changes in blood concentrations of micronutrients related to fishintake between groups from baseline and after 8 weeks intervensjon
measure: Changes in blood concentration of amino acids
timeFrame: Changes in blood concentrations of amino acids between groups postprandially, and between baseline and 8 weeks of intervention
measure: Body weight
timeFrame: Change between groups from baseline and after 8 weeks intervensjon will be calculated
measure: Height
timeFrame: Change between groups from baseline and after 8 weeks intervensjon will be calculated
Locations:
city: Oslo
country: Norway
facility: University of Oslo
state: Post Box 1046, Blindern
Study officials:
affiliation: University of Oslo
name: Kirsten Holven, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.