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Completed

NCT Number: NCT01894542

A Study of the Effects of Intake of Two 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.

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Key information

Conditions

Overweight Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

20 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Bergen

Bergen, Norway

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cod protein from presscake

Dietary Supplement

6g protein per day for 8wk

Cod protein from presscake + stickwater

Dietary Supplement

6 g protein per day for 8 wk

Control

Dietary Supplement

Primary outcomes

  1. Glucose tolerance

    Time frame: 8 weeks

    Serum glucose will be measured in fasting and postprandial state

Secondary outcomes

  1. Gene expression

    Time frame: 8 weeks

    Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation.

  2. Amino acids and amino acid metabolites

    Time frame: 8 weeks

    Amino acids and amino acid metabolites will be measured in serum and urine

  3. 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

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • Granit AS Transport & Tourism
  • Nofima
  • Norwegian Seafood Center

Registry information

Official study title

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

Acronym: FISK4

Important dates

Study start
2013
Primary completion
2014
Study completion
2019
First posted
Jul 10, 2013
Registry last updated
Apr 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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