Clinical trial 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.
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Overweight and Obesity
Healthy
Lead sponsor: University of Bergen
Sponsor class: OTHER
Collaborators: name: The Research Council of Norway
name: K. Halstensen AS
name: Regional Research Fund Western Norway
name: Nofima
First posted: 2018-05-29
Enrollment: 100
Sex: ALL
Minimum age (years): 20
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Biomarkers related to lipid metabolism
timeFrame: 8 weeks
Secondary outcomes:
measure: Biomarkers related to glucose regulation
timeFrame: 8 weeks
measure: Inflammatory markers
timeFrame: 8 weeks
measure: Body composition
timeFrame: 8 weeks
Other outcomes:
Locations:
city: Bergen
country: Norway
facility: Oddrun Anita Gudbrandsen
Study officials:
References:
citation: Vikoren LA, Nygard 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.
citation: Drotningsvik A, Mjos SA, Pampanin DM, Slizyte R, Carvajal A, Remman T, Hogoy 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. doi: 10.1017/S0007114516003548. Epub 2016 Oct 18.