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Completed

NCT Number: NCT03538821

The Effects of Intake of Protein From Cod Fillet and Cod Residual Material on Lipid Regulation, Glucose Regulation and Inflammation in Overweight or Obese Adults.

A high intake of fish is associated with positive health effects, including prevention and treatment of chronic non-communicable diseases, such as cardiovascular diseases (CVDs) and type 2 diabetes. These health effects have traditionally been attributed to the omega-3 fatty acids in fatty fish, but recent studies have suggested that also fish proteins may improve biomarkers of metabolic disease. Intake of cod fillet have previously shown beneficial effects on blood lipids, glucose regulation and body composition in adults with overweight or obesity. Health effect of cod residual material from fillet production (i.e., head, backbone, skin, cutoffs and entrails) have so far not been investigated, but residuals from other fish species have shown promising effects on glucose regulation in rats. The main aim of the current study is to investigate the effects of protein from cod fillet and cod residuals on serum lipids, glucose regulation and inflammatory markers in healthy overweight or obese adults.

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Key information

Conditions

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

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Oddrun Anita Gudbrandsen

Bergen, 5053, Norway

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • BMI ≥ 27 kg/m2
  • Fasting blood glucose ≤7 mmol/L
  • Physically inactive
  • Percent body fat > 25 % for men and > 35 % for women

Exclusion criteria

  • Allergies towards fish, milk, egg, gluten
  • Tobacco use > 10 cigarettes (or snus) per day
  • Diseases affecting the heart, intestinal function, kidney function or insulin secretion
  • Medications targeting cholesterol -or glucose metabolism, hypertension
  • Use of dietary supplements
  • Pregnancy or lactation

Treatment and study plan

Intact cod protein from fillet

Dietary Supplement

Intact cod protein from fillet 8 g protein daily for 8 weeks

Intact cod protein from residual material

Dietary Supplement

Intact cod protein from residual material, 8 g protein daily for 8 weeks

Control

Dietary Supplement

Control group receive tablet containing fillers

Primary outcomes

  1. Biomarkers related to lipid metabolism

    Time frame: 8 weeks

    Lipids will be measured in fasting serum samples

Secondary outcomes

  1. Biomarkers related to glucose regulation

    Time frame: 8 weeks

    Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions.

  2. Inflammatory markers

    Time frame: 8 weeks

    Cytokines will be measured in fasting serum/plasma

  3. Body composition

    Time frame: 8 weeks

    Percent body fat will be measured using bioimpedance

Sponsors and collaborators

Lead sponsor

University of Bergen

Other

Collaborators

  • K. Halstensen AS
  • Nofima
  • Regional Research Fund Western Norway
  • The Research Council of Norway

Registry information

Official study title

The Effects of a Daily Intake of Protein From Cod Fillet and Cod Residual Material for 8 Weeks on Serum Lipids and Fatty Acids, Glucose Regulation and Inflammation Markers in Overweight or Obese Adults: A Randomized Controlled Trial.

Acronym: COD2017

Important dates

Study start
2017
Primary completion
2019
Study completion
2021
First posted
May 29, 2018
Registry last updated
Jan 4, 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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