The Effects of Dietary Intake of Cod Residual Material Meal on Lipid Regulation, Glucose Regulation and Body Composition in Physically Active 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 cod residual meal on serum lipids and glucose regulation in healthy, physically active adults.

Official Title
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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.

Conditions
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Physical Activity, Healthy

Intervention / Treatment
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* Dietary Supplement: Cod meal from residual material
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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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

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: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Body composition | Percent body fat will be measured using bioimpedance | 8 weeks |