A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults (FISK4)

March 29, 2022 updated by: Oddrun Anita Gudbrandsen, University of Bergen

An 8 Week Study to Compare the Effects of Two Combinations of Water Soluble and Non-water Soluble Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Bergen, Norway
        • University of Bergen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cod protein from presscake
Dietary supplement: Cod protein from presscake
6g protein per day for 8wk
Experimental: Cod protein from presscake + stickwater
Dietary supplement: Cod protein from presscake + stickwater
6 g protein per day for 8 wk
Placebo Comparator: Control
Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets).
Dietary supplement: Control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Glucose tolerance
Time Frame: 8 weeks
Serum glucose will be measured in fasting and postprandial state
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine
Time Frame: 8 weeks
Concentrations of relevant metabolites and co-factors were measured in serum and urine
8 weeks
Gene expression
Time Frame: 8 weeks
Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.
8 weeks
Amino acids and amino acid metabolites
Time Frame: 8 weeks
Amino acids and amino acid metabolites will be measured in serum and urine
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Bergen

Collaborators

Nofima
Granit AS Transport & Tourism
Norwegian Seafood Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2019

Study Registration Dates

First Submitted

July 3, 2013

First Submitted That Met QC Criteria

July 9, 2013

First Posted (Estimate)

July 10, 2013

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 29, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2011/572-14

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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