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

Healthy Clinical Trial

— COD2016  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03538834
• Other study ID #: 2015/75 part 2
• Status: Completed
• Phase: N/A
• Start date: January 2016
• Est. completion date: December 2021

Study information

• Verified date: March 2022
• Source: University of Bergen
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: December 2021
• Est. primary completion date: December 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy
• Physical Activity

Intervention

Dietary Supplement:
• Cod meal from residual material
Cod meal from residual material, 8 g protein daily for 8 weeks
• Control
Placebo

Locations

Country	Name	City	State
Norway	Oddrun Anita Gudbrandsen	Bergen

Sponsors (5)

Lead Sponsor	Collaborator
University of Bergen	K. Halstensen AS, Nofima, Regional Research Fund Western Norway, The Research Council of Norway

Country where clinical trial is conducted

Norway, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Lipid metabolism	Lipids will be measured in fasting serum samples	8 weeks
Secondary	Biomarkers related to glucose regulation	Glucose, insulin and GLP-1 and will be measured in serum/plasma sampled in fasting and postprandial conditions	8 weeks
Secondary	Body composition	Percent body fat will be measured using bioimpedance	8 weeks