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.

Not Applicable

Completed

• Conditions: Overweight and Obesity; Healthy
• Interventions: Dietary Supplement: Intact cod protein from fillet; Dietary Supplement: Intact cod protein from residual material; Dietary Supplement: Control

• Registration Number: NCT03538821
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Study First Submitted: 2018-05-14
• Study First Submitted QC: 2018-05-24
• Study First Posted: 2018-05-29
• Primary Completion: 2019-12
• Study Completion: 2021-12
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-03
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intact cod protein from fillet	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	Intact cod protein from residual material	Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks
Control	Control	Control group receive tablet containing fillers and no proteins

Primary Outcome Measures

Name	Time	Method
Biomarkers related to lipid metabolism	8 weeks	Lipids will be measured in fasting serum samples

Secondary Outcome Measures

Name	Time	Method
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.
Inflammatory markers	8 weeks	Cytokines will be measured in fasting serum/plasma
Body composition	8 weeks	Percent body fat will be measured using bioimpedance

Trial Locations

Locations (1)

Oddrun Anita Gudbrandsen; 🇳🇴 Bergen, Norway