Health Effects of Salmon Fishmeal in Humans

NCT ID: NCT03764423

Last Updated: 2021-09-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 88 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-14
• Study Completion Date: 2019-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Salmon fishmeal

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

Group Type: EXPERIMENTAL

Salmon fishmeal

Intervention Type: DIETARY_SUPPLEMENT

Salmon fishmeal with high protein content

Microcrystalline cellulose

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

Group Type: PLACEBO_COMPARATOR

Microcrystalline cellulose

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

Salmon fishmeal

Salmon fishmeal with high protein content

Intervention Type: DIETARY_SUPPLEMENT

Microcrystalline cellulose

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

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Fish protein; Cellulose

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

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Oslo

OTHER

Sponsor Role: lead

Responsible Party

Kirsten Holven

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kirsten Holven, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

University of Oslo

Oslo, Post Box 1046, Blindern, Norway

Countries

Norway

References

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.

Reference Type: DERIVED

PMID: 35362766 (View on PubMed)

Other Identifiers

901420

Identifier Type: -

Identifier Source: org_study_id