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.

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Overweight and Obesity, Healthy

Intervention / Treatment
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* Dietary Supplement: Intact cod protein from fillet
* Dietary Supplement: Intact cod protein from residual material
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intact cod protein from fillet<br>Dietary supplement: intact cod protein from fillet, 8 g protein daily for 8 weeks | Dietary Supplement: Intact cod protein from fillet<br>* Intact cod protein from fillet 8 g protein daily for 8 weeks<br>|
| Experimental: Intact cod protein from residual material<br>Dietary supplement: intact cod protein from residual material, 8 g protein daily for 8 weeks | Dietary Supplement: Intact cod protein from residual material<br>* Intact cod protein from residual material, 8 g protein daily for 8 weeks<br>|
| Experimental: Control<br>Control group receive tablet containing fillers and no proteins | Dietary Supplement: Control<br>* Control group receive tablet containing fillers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers related to lipid metabolism | Lipids will be measured in fasting serum samples | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Inflammatory markers | Cytokines will be measured in fasting serum/plasma | 8 weeks | 
| Body composition | Percent body fat will be measured using bioimpedance | 8 weeks |