Dietary Fish Protein in Subjects With Insulin Resistance
Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Feb 2004
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2004
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedFirst Submitted
Initial submission to the registry
November 14, 2006
CompletedFirst Posted
Study publicly available on registry
November 16, 2006
CompletedNovember 16, 2006
November 1, 2006
November 14, 2006
November 14, 2006
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Insulin sensitivity at 4 weeks
Insulin signaling in skeletal muscle at 4 weeks
Secondary Outcomes (3)
plasma lipids and lipoproteins at 4 weeks
plasma inflammatory markers at 4 weeks
glucose tolerance at 4 weeks
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Canadian Institutes of Health Research (CIHR)collaborator
Study Sites (1)
Laval University
Québec, Quebec, G1K 7P4, Canada
Related Publications (1)
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.
PMID: 17682120DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helene Jacques, PhD
Laval University
- PRINCIPAL INVESTIGATOR
Andre Marette, PhD
Laval University
- PRINCIPAL INVESTIGATOR
Stanley J Weisnagel, MD / FRCPC
Laval University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
November 14, 2006
First Posted
November 16, 2006
Study Start
February 1, 2004
Study Completion
December 1, 2005
Last Updated
November 16, 2006
Record last verified: 2006-11