Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

NCT ID: NCT04078958

Last Updated: 2021-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-15

Study Completion Date

2019-11-07

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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 physiological and molecular effects of fish protein in the form of salmon fishmeal compared to whey in a human intervention study with regard to carbohydrate- and fat metabolism, endocrine factors and inflammation.

The investigators will include healthy subjects to a randomized controlled cross over study. The subjects will receive a single, oral dose of fishmeal or whey. Blood samples are taken before (fasting) and 30 and 60 minutes after intake. The molecular effects of fishmeal and whey are investigated ex vivo. This is done by incubating human cell lines (i.e hepatocytes, adipocytes, epithelial cells) with fasting and postprandial serum from the participants.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Metabolic Disease Inflammation Endocrine; Obesity

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Salmon fishmeal

5 g fishmeal in capsules, single oral dose

Group Type EXPERIMENTAL

Salmon fishmeal

Intervention Type DIETARY_SUPPLEMENT

Salmon fishmeal with high protein content

Whey

5 g whey in capsules, single oral dose

Group Type ACTIVE_COMPARATOR

Whey

Intervention Type DIETARY_SUPPLEMENT

Whey with high protein content

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Salmon fishmeal

Salmon fishmeal with high protein content

Intervention Type DIETARY_SUPPLEMENT

Whey

Whey with high protein content

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Body mass index 18.5-24.9 kg/m2

Exclusion Criteria

* Body mass index \<18.5 or \>24.9 kg/m2
* Known diabetes or high blood pressure
* Pregnancy or breast feeding
* Allergy or intolerance to dairy or fish/fish protein.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

University of Oslo

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Kirsten Holven

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kirsten Holven

Role: PRINCIPAL_INVESTIGATOR

University of Oslo

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Oslo

Oslo, , Norway

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Norway

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2019/875/REK sør-øst B

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.