COD2016: The Effects of Dietary Intake of Cod Residual Material Meal on Lipid Regulation, Glucose Regulation and Body Composition in Physically Active Adults

• Sponsor: University of Bergen (Other)
• Overall Status: Completed
• CT.gov ID: NCT03538834
• Collaborator: The Research Council of Norway (Other), K. Halstensen AS (Other), Regional Research Fund Western Norway (Other), Nofima (Other)
• Enrollment: 70
• Location: 1
• Arms: 2
• Actual Duration (Months): 71
• Patients Per Site Per Month: 1

Study Details

Study Description

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 cod residual meal on serum lipids and glucose regulation in healthy, physically active adults.

Condition or Disease	Intervention/Treatment	Phase
Physical Activity; Healthy	Dietary Supplement: Cod meal from residual material; Dietary Supplement: Control	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 70 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Basic Science
• Official Title: The Effects of a Daily Intake of Cod Residual Material Meal for 8 Weeks on Serum Lipids and Fatty Acids, Glucose Regulation and Body Composition in Lean, Active Adults: A Randomized Controlled Trial.
• Actual Study Start Date: Jan 1, 2016
• Actual Primary Completion Date: Dec 1, 2019
• Actual Study Completion Date: Dec 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cod meal from residual material Dietary supplement: cod meal from residual material, 8 g protein daily for 8 weeks	Dietary Supplement: Cod meal from residual material; Cod meal from residual material, 8 g protein daily for 8 weeks
Placebo Comparator: Control Control group receive tablet containing fillers and no protein	Dietary Supplement: Control; Placebo

Outcome Measures

Primary Outcome Measures

1. Lipid metabolism [8 weeks]

   Lipids will be measured in fasting serum samples

Secondary Outcome Measures

1. Biomarkers related to glucose regulation [8 weeks]

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

2. Body composition [8 weeks]

   Percent body fat will be measured using bioimpedance

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Inclusion Criteria:

• BMI ≥ 18.5 kg/m2

• Fasting blood glucose ≤7 mmol/L

• Physically active

• Percent body fat, 5-25 % for men and 12-35 % 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Oddrun Anita Gudbrandsen	Bergen		Norway

Sponsors and Collaborators

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

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

• Drotningsvik A, Mjøs SA, Pampanin DM, Slizyte R, Carvajal A, Remman T, Høgøy I, Gudbrandsen OA. Dietary fish protein hydrolysates containing bioactive motifs affect serum and adipose tissue fatty acid compositions, serum lipids, postprandial glucose regulation and growth in obese Zucker fa/fa rats. Br J Nutr. 2016 Oct;116(8):1336-1345. Epub 2016 Oct 18.
• Vikøren LA, Nygård 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.
• Vildmyren I, Cao HJV, Haug LB, Valand IU, Eng Ø, Oterhals Å, Austgulen MH, Halstensen A, Mellgren G, Gudbrandsen OA. Daily Intake of Protein from Cod Residual Material Lowers Serum Concentrations of Nonesterified Fatty Acids in Overweight Healthy Adults: A Randomized Double-Blind Pilot Study. Mar Drugs. 2018 Jun 5;16(6). pii: E197. doi: 10.3390/md16060197.

• Responsible Party: Oddrun Anita Gudbrandsen, Researcher, PhD, University of Bergen
• ClinicalTrials.gov Identifier: NCT03538834
• Other Study ID Numbers: 2015/75 part 2
• First Posted: May 29, 2018
• Last Update Posted: Mar 31, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 31, 2022