Health Effects of Salmon Fishmeal in Humans

Impaired Glucose Tolerance Clinical Trial

— FishMeal  

Official title:

Health Effects of Salmon Fishmeal in Humans With Impaired Glucose Tolerance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03764423
• Other study ID #: 901420
• Status: Completed
• Phase: N/A
• Start date: September 14, 2018
• Est. completion date: November 1, 2019

Study information

• Verified date: September 2021
• Source: University of Oslo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Glucose Intolerance
• Impaired Glucose Tolerance

Intervention

Dietary Supplement:
• Salmon fishmeal
Salmon fishmeal with high protein content
• Microcrystalline cellulose
Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.

Locations

Country	Name	City	State
Norway	University of Oslo	Oslo	Post Box 1046, Blindern

Sponsors (1)

Lead Sponsor	Collaborator
University of Oslo

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Other	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
Primary	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
Primary	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	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
Secondary	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
Secondary	Blood concentration of HbA1c	Blood concentration measured fasting	Changes in blood HbA1c concentration from baseline and after 8 weeks between groups
Secondary	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