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Clinical Trials/NCT01894542
NCT01894542CompletedNot Applicable

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

University of Bergen1 site in 1 country55 target enrollmentStarted: August 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
55
Locations
1
Primary Endpoint
Glucose tolerance

Study Overview

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.

Detailed Description

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

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •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

Arms & Interventions

Cod protein from presscake

Experimental

Intervention: Cod protein from presscake (Dietary Supplement)

Cod protein from presscake + stickwater

Experimental

Intervention: Cod protein from presscake + stickwater (Dietary Supplement)

Control

Placebo Comparator

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

Intervention: Control (Dietary Supplement)

Outcomes

Primary Outcomes

Glucose tolerance

Time Frame: 8 weeks

Serum glucose will be measured in fasting and postprandial state

Secondary Outcomes

  • Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine(8 weeks)
  • Gene expression(8 weeks)
  • Amino acids and amino acid metabolites(8 weeks)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Oddrun Anita Gudbrandsen

PhD

University of Bergen

Study Sites (1)

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