Dietary Fish Protein in Subjects With Insulin Resistance

Study Overview
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Brief Summary
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The objective of our research project is to determine the effects of fish protein, present in fish, on insulin sensitivity in insulin-resistant human individuals, and its mechanism of action on glucose metabolism. Our hypothesis is that fish protein improves insulin sensitivity, glucose tolerance and plasma lipid profile through an improvement in a primary defect in insulin signaling in overweight and insulin-resistant subjects.

Detailed Description
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Recent data show that cod protein prevents the development of insulin resistance in rats. Dietary fish protein may also enhance insulin sensitivity in overweight insulin-resistant subjects by improving a primary defect in insulin signaling to PI 3-kinase, leading to reduced activation of the downstream effectors Akt and PKC. To determine whether this is the case, we will study the effects of fish protein on insulin sensitivity in humans, and how it improves the ability of muscles to use glucose. Such studies will help to advise individuals with insulin resistance or type 2 diabetes about eating fish.

Official Title
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Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein

Conditions
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Insulin Resistance, Type 2 Diabetes

Intervention / Treatment
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* Behavioral: Cod protein NCEP-diet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: overweight or obese (BMI between 25 and 40 kg /m2) waist circumference above 88 cm for women and 102 cm for men fasting plasma insulin above 90 pmol/L fasting plasma glucose below 7.0 mmol/L and 2-h plasma glucose below 11.1 mmol/L Exclusion Criteria: Individuals with diagnosed diabetes or any chronic, metabolic or acute disease Individuals who had a major surgery within the last 3 months Individuals who had a significant weight loss (±10%) within the last 6 months Individuals taking any medication known to affect lipid or glucose metabolism Subjects with dietary incompatibility with fish consumption (allergy, intolerance or dislike) and/or calcium supplementation Smokers

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Cod protein NCEP-diet|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin sensitivity at 4 weeks |  |  | 
| Insulin signaling in skeletal muscle at 4 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| plasma lipids and lipoproteins at 4 weeks |  |  | 
| plasma inflammatory markers at 4 weeks |  |  | 
| glucose tolerance at 4 weeks |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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glucose tolerance, cod protein, insulin sensitivity, plasma lipids, plasma inflammatory markers, skeletal muscle insulin signaling, type 2 diabetes, humans