Dietary Fish Protein in Subjects With Insulin Resistance

Sponsor

Laval University (Other)

Overall Status

Completed

CT.gov ID

NCT00400036

Collaborator

Canadian Institutes of Health Research (CIHR) (Other)

Enrollment

Location

Duration (Months)

1.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Insulin Resistance Type 2 Diabetes	Behavioral: Cod protein NCEP-diet	Phase 2

Detailed Description

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.

Study Design

Study Type:

Interventional

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

Feb 1, 2004

Study Completion Date :

Dec 1, 2005

Outcome Measures

Primary Outcome Measures

Insulin sensitivity at 4 weeks []
Insulin signaling in skeletal muscle at 4 weeks []

Secondary Outcome Measures

plasma lipids and lipoproteins at 4 weeks []
plasma inflammatory markers at 4 weeks []
glucose tolerance at 4 weeks []

Eligibility Criteria

Criteria

Ages Eligible for Study:

35 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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