A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

NCT ID: NCT01894542

Last Updated: 2022-04-07

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

55 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2019-12-31

Brief Summary

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The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.

Detailed Description

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Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.

Conditions

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Overweight Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Cod protein from presscake

Group Type EXPERIMENTAL

Cod protein from presscake

Intervention Type DIETARY_SUPPLEMENT

6g protein per day for 8wk

Cod protein from presscake + stickwater

Group Type EXPERIMENTAL

Cod protein from presscake + stickwater

Intervention Type DIETARY_SUPPLEMENT

6 g protein per day for 8 wk

Control

Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets).

Group Type PLACEBO_COMPARATOR

Control

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Cod protein from presscake

6g protein per day for 8wk

Intervention Type DIETARY_SUPPLEMENT

Cod protein from presscake + stickwater

6 g protein per day for 8 wk

Intervention Type DIETARY_SUPPLEMENT

Control

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* BMI\>28
* healthy
* fasting blood glucose \<7.0 mmol/L
* stable body weight with less than 5 kg fluctuation during the last 4 months

Exclusion Criteria

* known disease or metabolic disturbances related to overweight or obesity
* use of prescription medications that affect blood glucose, blood lipids or inflammatory status
* allergies towards fish or seafood
* undertaking a weight loss diet
* tobacco use exceeding \>15 cigarettes/day
* pregnancy or breastfeeding
* high seafood consumption
* use of dietary supplements including cod liver oil or other marine fatty acids
* allergies towards fish, milk, egg
Minimum Eligible Age

20 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Granit AS Transport & Tourism

OTHER

Sponsor Role collaborator

Norwegian Seafood Center

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

PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University of Bergen

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)

Other Identifiers

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2011/572-14

Identifier Type: -

Identifier Source: org_study_id

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