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Dietary Fish Protein in Subjects With Insulin Resistance

NCT ID: NCT00400036

Last Updated: 2006-11-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-02-29

Study Completion Date

2005-12-31

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.

Conditions

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Insulin Resistance Type 2 Diabetes

Keywords

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cod protein insulin sensitivity plasma lipids glucose tolerance plasma inflammatory markers skeletal muscle insulin signaling type 2 diabetes humans

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Interventions

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Cod protein NCEP-diet

Intervention Type BEHAVIORAL

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
Minimum Eligible Age

35 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Principal Investigators

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Helene Jacques, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Andre Marette, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Stanley J Weisnagel, MD / FRCPC

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval University

Québec, Quebec, Canada

Site Status

Countries

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Canada

References

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Ouellet V, Marois J, Weisnagel SJ, Jacques H. Dietary cod protein improves insulin sensitivity in insulin-resistant men and women: a randomized controlled trial. Diabetes Care. 2007 Nov;30(11):2816-21. doi: 10.2337/dc07-0273. Epub 2007 Aug 6.

Reference Type DERIVED
PMID: 17682120 (View on PubMed)

Other Identifiers

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MOP-64443

Identifier Type: -

Identifier Source: org_study_id