Dietary Fish Protein in Subjects With Insulin Resistance

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. Identifier: NCT00400036
Recruitment Status : Completed
First Posted : November 16, 2006
Last Update Posted : November 16, 2006
Canadian Institutes of Health Research (CIHR)
Information provided by:
Laval University

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 Type : Interventional  (Clinical Trial)
Enrollment : 24 participants
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 : February 2004
Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Primary Outcome Measures :
  1. Insulin sensitivity at 4 weeks
  2. Insulin signaling in skeletal muscle at 4 weeks

Secondary Outcome Measures :
  1. plasma lipids and lipoproteins at 4 weeks
  2. plasma inflammatory markers at 4 weeks
  3. glucose tolerance at 4 weeks

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00400036

Canada, Quebec
Laval University
Quebec city, Quebec, Canada, G1K 7P4
Sponsors and Collaborators
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

Publications automatically indexed to this study by Identifier (NCT Number): Identifier: NCT00400036     History of Changes
Other Study ID Numbers: MOP-64443
First Posted: November 16, 2006    Key Record Dates
Last Update Posted: November 16, 2006
Last Verified: November 2006

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

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