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Dietary Fish Protein in Subjects With Insulin Resistance

This study has been completed.
Sponsor:
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT00400036
First received: November 14, 2006
Last updated: NA
Last verified: November 2006
History: No changes posted
  Purpose

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 Intervention Phase
Insulin Resistance
Type 2 Diabetes
 Behavioral: Cod protein NCEP-diet
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Laval University:

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

Estimated Enrollment: 24
Study Start Date: February 2004
Estimated Study Completion Date: December 2005
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.

  Eligibility

Ages Eligible for Study:   35 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00400036

Locations
Canada, Quebec
Laval University
Quebec city, Quebec, Canada, G1K 7P4
Sponsors and Collaborators
Laval University
Canadian Institutes of Health Research (CIHR)
Investigators
Principal Investigator: Helene Jacques, PhD Laval University
Principal Investigator: Andre Marette, PhD Laval University
Principal Investigator: Stanley J Weisnagel, MD / FRCPC Laval University
  More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00400036     History of Changes
Other Study ID Numbers: MOP-64443
Study First Received: November 14, 2006
Last Updated: November 14, 2006
Health Authority: Canada: Ethics Review Committee
Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
cod protein
insulin sensitivity
plasma lipids
glucose tolerance
 plasma inflammatory markers
skeletal muscle insulin signaling
type 2 diabetes
humans

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Hyperinsulinism
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 23, 2013