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Dietary Fish Protein in Subjects With Insulin Resistance

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00400036
First Posted: November 16, 2006
Last Update Posted: November 16, 2006
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Canadian Institutes of Health Research (CIHR)
Information provided by:
Laval University
November 14, 2006
November 16, 2006
November 16, 2006
February 2004
Not Provided
  • Insulin sensitivity at 4 weeks
  • Insulin signaling in skeletal muscle at 4 weeks
Same as current
No Changes Posted
  • plasma lipids and lipoproteins at 4 weeks
  • plasma inflammatory markers at 4 weeks
  • glucose tolerance at 4 weeks
Same as current
Not Provided
Not Provided
 
Dietary Fish Protein in Subjects With Insulin Resistance
Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
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.
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.
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Insulin Resistance
  • Type 2 Diabetes
Behavioral: Cod protein NCEP-diet
Not Provided
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. Epub 2007 Aug 6.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
24
December 2005
Not Provided

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
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
 
NCT00400036
MOP-64443
Not Provided
Not Provided
Not Provided
Not Provided
Laval University
Canadian Institutes of Health Research (CIHR)
Principal Investigator: Helene Jacques, PhD Laval University
Principal Investigator: Andre Marette, PhD Laval University
Principal Investigator: Stanley J Weisnagel, MD / FRCPC Laval University
Laval University
November 2006

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP