Effects of Salmon Fishmeal Ex Vivo (FishMeal Ex Vivo)

NCT04078958 | Completed

• 1 other identifier: 2019/875/REK sør-øst B
• Study Type: interventional
• Target: 5
• 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 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.

Conditions

Metabolic Disease; Inflammation; Endocrine; Obesity

Outcome Measures

Primary Outcomes (1)

• Changes in the whole genome transciptome in cultured cells

  Changes in the whole genome transciptome of cultured cells incubated with fasting and postprandial serum from participants receiving whey or fishmeal.

  Acute changes from baseline to 30 and/or 60 minutes.

Secondary Outcomes (10)

• Changes in histone marks on selected target genes in cultured cell lines

  Acute changes from baseline to 30 and/or 60 minutes.

• Changes in insulin-stimulated glucose uptake in cultured cell lines

  Acute changes from baseline to 30 and/or 60 minutes.

• Changes in cytokine secretion in cultured cell lines

  Acute changes from baseline to 30 and/or 60 minutes.

• Blood concentration of insulin

  Acute changes from baseline to 30 and 60 minutes

• Blood concentration of glucose

  Acute changes from baseline to 30 and 60 minutes

Study Arms (2)

Salmon fishmeal

EXPERIMENTAL

5 g fishmeal in capsules, single oral dose

Dietary Supplement: Salmon fishmeal

Whey

ACTIVE COMPARATOR

5 g whey in capsules, single oral dose

Dietary Supplement: Whey

Interventions

Salmon fishmeal DIETARY_SUPPLEMENT

Salmon fishmeal with high protein content

Salmon fishmeal

Whey DIETARY_SUPPLEMENT

Whey with high protein content

Whey

Eligibility Criteria

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

You may qualify if:

• Body mass index 18.5-24.9 kg/m2

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Oslo: lead

Study Sites (1)

University of Oslo

Oslo, Norway

Location

MeSH Terms

Conditions

Metabolic Diseases; Inflammation; Obesity

Interventions

Whey

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Milk; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Dairy Products; Food; Food and Beverages

Study Officials

• Kirsten Holven

  University of Oslo

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: August 29, 2019
• First Posted: September 6, 2019
• Study Start: October 15, 2019
• Primary Completion: November 7, 2019
• Study Completion: November 7, 2019
• Last Updated: September 28, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)