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Dietary Fish Protein in Subjects With Insulin Resistance

Primary Purpose

Insulin Resistance, Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Cod protein NCEP-diet
Sponsored by
Laval University
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance focused on measuring cod protein, insulin sensitivity, plasma lipids, glucose tolerance, plasma inflammatory markers, skeletal muscle insulin signaling, type 2 diabetes, humans

Eligibility Criteria

35 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Laval University

Outcomes

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

Full Information

First Posted
November 14, 2006
Last Updated
November 14, 2006
Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT00400036
Brief Title
Dietary Fish Protein in Subjects With Insulin Resistance
Official Title
Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
Study Type
Interventional

2. Study Status

Record Verification Date
November 2006
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2005 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)

4. Oversight

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Type 2 Diabetes
Keywords
cod protein, insulin sensitivity, plasma lipids, glucose tolerance, plasma inflammatory markers, skeletal muscle insulin signaling, type 2 diabetes, humans

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Cod protein NCEP-diet
Primary Outcome Measure Information:
Title
Insulin sensitivity at 4 weeks
Title
Insulin signaling in skeletal muscle at 4 weeks
Secondary Outcome Measure Information:
Title
plasma lipids and lipoproteins at 4 weeks
Title
plasma inflammatory markers at 4 weeks
Title
glucose tolerance at 4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
35 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Jacques, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Marette, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Stanley J Weisnagel, MD / FRCPC
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Quebec city
State/Province
Quebec
ZIP/Postal Code
G1K 7P4
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17682120
Citation
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.
Results Reference
derived

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Dietary Fish Protein in Subjects With Insulin Resistance

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