The Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults.

NCT ID: NCT03538821

Last Updated: 2022-01-04

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2021-12-31

Brief Summary

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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 protein from cod fillet and cod residuals on serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese adults.

Detailed Description

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Conditions

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Overweight and Obesity Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intact cod protein from fillet

Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks

Group Type EXPERIMENTAL

Intact cod protein from fillet

Intervention Type DIETARY_SUPPLEMENT

Intact cod protein from fillet 8 g protein daily for 8 weeks

Intact cod protein from residual material

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

Group Type EXPERIMENTAL

Intact cod protein from residual material

Intervention Type DIETARY_SUPPLEMENT

Intact cod protein from residual material, 8 g protein daily for 8 weeks

Control

Control group receive tablet containing fillers and no proteins

Group Type EXPERIMENTAL

Control

Intervention Type DIETARY_SUPPLEMENT

Control group receive tablet containing fillers

Interventions

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Intact cod protein from fillet

Intact cod protein from fillet 8 g protein daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Intact cod protein from residual material

Intact cod protein from residual material, 8 g protein daily for 8 weeks

Intervention Type DIETARY_SUPPLEMENT

Control

Control group receive tablet containing fillers

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI ≥ 27 kg/m2
* Fasting blood glucose ≤7 mmol/L
* Physically inactive
* Percent body fat \> 25 % for men and \> 35 % for women

Exclusion Criteria

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Research Council of Norway

OTHER

Sponsor Role collaborator

K. Halstensen AS

UNKNOWN

Sponsor Role collaborator

Regional Research Fund Western Norway

UNKNOWN

Sponsor Role collaborator

Nofima

OTHER

Sponsor Role collaborator

University of Bergen

OTHER

Sponsor Role lead

Responsible Party

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Oddrun Anita Gudbrandsen

Researcher, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Oddrun Anita Gudbrandsen

Bergen, , Norway

Site Status

Countries

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Norway

References

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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.

Reference Type BACKGROUND
PMID: 22647247 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27751188 (View on PubMed)

Other Identifiers

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2015/75 part 1

Identifier Type: -

Identifier Source: org_study_id

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