A Study of the Effects of Intake of Two Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

Study Overview
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Brief Summary
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The investigators have previously shown the intact protein from cod filet improves glucose regulation and serum lipid profile in overweight adults. A large amount of trimmings from various fish species such as cod is thrown away or sold at very low prices for animal feed, and analyses of the amino acid composition reveals that this can be a good protein source for humans. Two fractions are normally isolated from intact fish meal, i.e. water soluble and non-water soluble proteins. In the present study the investigators will compare these fractions, by studying their effects on glucose regulation in overweight/obese adults.

Detailed Description
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Participants receive 6g per day of water soluble on non-water soluble cod protein as tablets for 8 weeks.

Official Title
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An 8 Week Study to Compare the Effects of Two Combinations of Water Soluble and Non-water Soluble Cod Residual Meals on Glucose Regulation in Overweight and Obese Adults

Conditions
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Overweight, Obesity

Intervention / Treatment
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* Dietary Supplement: Cod protein from presscake
* Dietary Supplement: Cod protein from presscake + stickwater
* Dietary Supplement: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BMI>28 healthy fasting blood glucose <7.0 mmol/L stable body weight with less than 5 kg fluctuation during the last 4 months Exclusion Criteria: known disease or metabolic disturbances related to overweight or obesity use of prescription medications that affect blood glucose, blood lipids or inflammatory status allergies towards fish or seafood undertaking a weight loss diet tobacco use exceeding >15 cigarettes/day pregnancy or breastfeeding high seafood consumption use of dietary supplements including cod liver oil or other marine fatty acids allergies towards fish, milk, egg

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cod protein from presscake<br> | Dietary Supplement: Cod protein from presscake<br>* 6g protein per day for 8wk<br>|
| Experimental: Cod protein from presscake + stickwater<br> | Dietary Supplement: Cod protein from presscake + stickwater<br>* 6 g protein per day for 8 wk<br>|
| Placebo Comparator: Control<br>Control group will receive tablet containing only tablet fillers (the same as in the cod protein tablets). | Dietary Supplement: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose tolerance | Serum glucose will be measured in fasting and postprandial state | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gene expression | Changes in gene expression in adipose tissue related to the circulating markers of glucose regulation. | 8 weeks | 
| Amino acids and amino acid metabolites | Amino acids and amino acid metabolites will be measured in serum and urine | 8 weeks | 
| Comparisons of metabolites and co-factors involved in one-carbon metabolism in serum and urine | Concentrations of relevant metabolites and co-factors were measured in serum and urine | 8 weeks |