NCT01894542

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2013

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

First Submitted

Initial submission to the registry

July 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2013

Completed
22 days until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2019

Completed
Last Updated

April 7, 2022

Status Verified

March 1, 2022

Enrollment Period

1.3 years

First QC Date

July 3, 2013

Last Update Submit

March 29, 2022

Conditions

OverweightObesity

Outcome Measures

Primary Outcomes (1)

  • Glucose tolerance

    Serum glucose will be measured in fasting and postprandial state

    8 weeks

Secondary Outcomes (3)

  • Gene expression

    8 weeks

  • Amino acids and amino acid metabolites

    8 weeks

  • Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine

    8 weeks

Study Arms (3)

Cod protein from presscake

EXPERIMENTAL
Dietary Supplement: Cod protein from presscake

Cod protein from presscake + stickwater

EXPERIMENTAL
Dietary Supplement: Cod protein from presscake + stickwater

Control

PLACEBO COMPARATOR

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

Dietary Supplement: Control

Interventions

Cod protein from presscakeDIETARY_SUPPLEMENT

6g protein per day for 8wk

Cod protein from presscake
Cod protein from presscake + stickwaterDIETARY_SUPPLEMENT

6 g protein per day for 8 wk

Cod protein from presscake + stickwater
ControlDIETARY_SUPPLEMENT
Control

Eligibility Criteria

Age20 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Bergen

Bergen, Norway

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

OverweightObesity

Condition Hierarchy (Ancestors)

OvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

July 3, 2013

First Posted

July 10, 2013

Study Start

August 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2019

Last Updated

April 7, 2022

Record last verified: 2022-03

Locations

NO(1)