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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. (COD2017)

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ClinicalTrials.gov Identifier: NCT03538821
Recruitment Status : Active, not recruiting
First Posted : May 28, 2018
Last Update Posted : May 28, 2018
Sponsor:
Collaborators:
The Research Council of Norway
K. Halstensen AS
Regional Research Fund Western Norway
Nofima
Information provided by (Responsible Party):
Oddrun Anita Gudbrandsen, University of Bergen

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Overweight and Obesity Healthy Dietary Supplement: Intact cod protein from fillet Dietary Supplement: Intact cod protein from residual material Dietary Supplement: Control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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.
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Arm Intervention/treatment
Experimental: Intact cod protein from fillet
Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks
Dietary Supplement: Intact cod protein from fillet
Intact cod protein from fillet 8 g protein daily for 8 weeks

Experimental: Intact cod protein from residual material
Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks
Dietary Supplement: Intact cod protein from residual material
Intact cod protein from residual material, 8 g protein daily for 8 weeks

Experimental: Control
Control group receive tablet containing fillers and no proteins
Dietary Supplement: Control
Control group receive tablet containing fillers




Primary Outcome Measures :
  1. Biomarkers related to lipid metabolism [ Time Frame: 8 weeks ]
    Lipids will be measured in fasting serum samples


Secondary Outcome Measures :
  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



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Ages Eligible for Study:   20 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03538821


Locations
Norway
Oddrun Anita Gudbrandsen
Bergen, Norway, 5053
Sponsors and Collaborators
University of Bergen
The Research Council of Norway
K. Halstensen AS
Regional Research Fund Western Norway
Nofima

Publications:
Responsible Party: Oddrun Anita Gudbrandsen, Researcher, PhD, University of Bergen
ClinicalTrials.gov Identifier: NCT03538821     History of Changes
Other Study ID Numbers: 2015/75 part 1
First Posted: May 28, 2018    Key Record Dates
Last Update Posted: May 28, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Inflammation
Overweight
Pathologic Processes
Body Weight
Signs and Symptoms