Health Effects of Salmon Fishmeal in Humans

NCT03764423 | Completed

• 1 other identifier: 901420
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Impaired Glucose Tolerance

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• Blood concentration of insulin

  Changes in blood insulin concentration from baseline and after 8 weeks between groups

• HOMA-IR

  Changes in HOMAR-IR from baseline and after 8 weeks between groups

• Blood concentration of HbA1c

  Changes in blood HbA1c concentration from baseline and after 8 weeks between groups

• Blood concentration of incretins (i.e. GLP-1)

  Changes in blood glucose concentration of increstins from baseline and after 8 weeks between groups

Other Outcomes (9)

• Markers related to lipid metabolism

  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

  Changes in blood concentrations of markers related to inflammation from baseline and after 8 weeks between groups

• Markers related to appetite

  Changes in blood concentrations of markers related to appetite from baseline and after 8 weeks between groups

Study Arms (2)

Salmon fishmeal

EXPERIMENTAL

7,5 g fishmeal and 7,5 g microcrytalline cellulose per day in capsules by mounth for 8 weeks

Dietary Supplement: Salmon fishmeal

Microcrystalline cellulose

PLACEBO COMPARATOR

7,5 g microcrystalline cellulose per day in capsules by mounth for 8 weeks

Dietary Supplement: Microcrystalline cellulose

Interventions

Salmon fishmeal DIETARY_SUPPLEMENT

Salmon fishmeal with high protein content

Also known as: Fish protein

Salmon fishmeal

Microcrystalline cellulose DIETARY_SUPPLEMENT

Microcrystalline cellulose contain no energy and is less fermented in the gut than other dietary fibers.

Also known as: Cellulose

Microcrystalline cellulose

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Post Box 1046, Blindern, 0317, Norway

Location

Related Publications (1)

• 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.

  PMID: 35362766 DERIVED

MeSH Terms

Conditions

Glucose Intolerance

Interventions

Fish Proteins; microcrystalline cellulose; Cellulose

Condition Hierarchy (Ancestors)

Hyperglycemia; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Proteins; Amino Acids, Peptides, and Proteins; Glucans; Biopolymers; Polymers; Macromolecular Substances; Polysaccharides; Carbohydrates; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Kirsten Holven, Professor

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 29, 2018
• First Posted: December 5, 2018
• Study Start: September 14, 2018
• Primary Completion: November 1, 2019
• Study Completion: November 1, 2019
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)