The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

Study Overview
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Brief Summary
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The aim of the project is to examine whether the sources of n-3 fatty acids and fish itself differ in their effects on glucose metabolism, lipid metabolism, blood pressure, and serum inflammatory markers. Lipidomic profiles and gene expression will be used for thorough assessment of the possible clinical changes. The study will compare the effects of alpha-linolenic acid containing vegetable oil, fatty fish, lean fish and control diet. The results of this project will help to identify the optimal source of n-3 fatty acids, and reveal the significance of the components of fish other than fatty acids. These data will be useful both nationally and internationally, since highly controlled dietary interventions utilizing new methodology are scarce.

Official Title
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The Effect of n-3 Fatty Acids and Fish on Glucose and Lipid Metabolism in Subjects With Impaired Glucose Metabolism

Conditions
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Hyperglycemia

Intervention / Treatment
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* Behavioral: Fatty fish
* Behavioral: Lean Fish
* Behavioral: Alpha-linolenic acid
* Behavioral: Control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 40-70 years BMI 25-32 kg/m2 fasting plasma glucose 5.6-7.0 mmol/l 2 h plasma glucose in oral glucose tolerance test <=11 mmol/l fasting serum total cholesterol <=7 mmol/l fasting serum LDL cholesterol <=5 mmol/l fasting serum triglycerides <=4 mmol/l Exclusion Criteria: any chronic disease or condition that hamper the ability to follow dietary intervention chronic liver, thyroid or kidney disease alcohol abuse diabetes recent weight loss recent myocardial infarction corticosteroid therapy psychiatric disorders which need drug treatment cancer under treatment fish allergy or other extensive food allergies exceptional diets (like Atkin's or vegan diet)

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fatty fish<br>Four fatty fish meals per week | Behavioral: Fatty fish<br> <br> |
| Experimental: Lean Fish<br>Four lean fish meals per week | Behavioral: Lean Fish<br> <br> |
| Experimental: Alpha-linolenic acid<br>10 g of alpha-linolenic acid daily from camelina sativa oil | Behavioral: Alpha-linolenic acid<br> <br> |
| Experimental: Control diet<br>Limited fish and alpha-linolenic acid intake | Behavioral: Control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose metabolism assessed by oral glucose tolerance test and frequently sampled intravenous glucose tolerance test | change in glucose metabolism | Baseline and 12 weeks | 
| Serum lipid profile | Change in serum lipid profile | Baseline and at 12 weeks | 
| Blood pressure | Change in blood pressure | Baseline and 12 weeks | 
| Serum inflammatory markers | Change in serum inflammatory markers | baseline and 12 weeks | 
| Plasma and adipose tissue lipidomic profile | Change in plasma and adipose tissue lipidomic profile | Baseline and 12 weeks | 
| Plasma and urine metabonomics | Change in plasma and urine metabonomics | Baseline and 12 weeks | 
| Gene expression in adipose tissue and peripheral blood mononuclear cells | Change in gene expression in adipose tissue and peripheral blood mononuclear cells | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reverse cholesterol transport | Change in reverse cholesterol transport | Baseline and 12 weeks |