NCT03538834

Brief Summary

A high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. Health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. The main aim of the current study is to investigate the effects of cod residual meal on serum lipids and glucose regulation in healthy, physically active adults.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 14, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

May 29, 2018

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2019

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

March 31, 2022

Status Verified

March 1, 2022

Enrollment Period

3.9 years

First QC Date

May 14, 2018

Last Update Submit

March 29, 2022

Conditions

Physical ActivityHealthy

Outcome Measures

Primary Outcomes (1)

  • Lipid metabolism

    Lipids will be measured in fasting serum samples

    8 weeks

Secondary Outcomes (2)

  • Biomarkers related to glucose regulation

    8 weeks

  • Body composition

    8 weeks

Study Arms (2)

Cod meal from residual material

EXPERIMENTAL

Dietary supplement: cod meal from residual material, 8 g protein daily for 8 weeks

Dietary Supplement: Cod meal from residual material

Control

PLACEBO COMPARATOR

Control group receive tablet containing fillers and no protein

Dietary Supplement: Control

Interventions

Cod meal from residual materialDIETARY_SUPPLEMENT

Cod meal from residual material, 8 g protein daily for 8 weeks

Cod meal from residual material
ControlDIETARY_SUPPLEMENT

Placebo

Control

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • BMI ≥ 18.5 kg/m2
  • Fasting blood glucose ≤7 mmol/L
  • Physically active
  • Percent body fat, 5-25 % for men and 12-35 % for women

You may not qualify if:

  • Allergies towards fish, milk, egg, gluten
  • Tobacco use \> 10 cigarettes (or snus) per day
  • Diseases affecting the heart, intestinal function, kidney function or insulin secretion
  • Medications targeting cholesterol -or glucose metabolism, hypertension
  • Use of dietary supplements
  • Pregnancy or lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oddrun Anita Gudbrandsen

Bergen, Norway

Location

Related Publications (3)

  • Vikoren LA, Nygard OK, Lied E, Rostrup E, Gudbrandsen OA. A randomised study on the effects of fish protein supplement on glucose tolerance, lipids and body composition in overweight adults. Br J Nutr. 2013 Feb 28;109(4):648-57. doi: 10.1017/S0007114512001717. Epub 2012 May 31.

    PMID: 22647247BACKGROUND

  • Drotningsvik A, Mjos SA, Pampanin DM, Slizyte R, Carvajal A, Remman T, Hogoy I, Gudbrandsen OA. Dietary fish protein hydrolysates containing bioactive motifs affect serum and adipose tissue fatty acid compositions, serum lipids, postprandial glucose regulation and growth in obese Zucker fa/fa rats. Br J Nutr. 2016 Oct;116(8):1336-1345. doi: 10.1017/S0007114516003548. Epub 2016 Oct 18.

    PMID: 27751188BACKGROUND

  • Vildmyren I, Cao HJV, Haug LB, Valand IU, Eng O, Oterhals A, Austgulen MH, Halstensen A, Mellgren G, Gudbrandsen OA. Daily Intake of Protein from Cod Residual Material Lowers Serum Concentrations of Nonesterified Fatty Acids in Overweight Healthy Adults: A Randomized Double-Blind Pilot Study. Mar Drugs. 2018 Jun 5;16(6):197. doi: 10.3390/md16060197.

    PMID: 29874805BACKGROUND

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Researcher, PhD

Study Record Dates

First Submitted

May 14, 2018

First Posted

May 29, 2018

Study Start

January 1, 2016

Primary Completion

December 1, 2019

Study Completion

December 1, 2021

Last Updated

March 31, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

NO(1)