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CompletedNCT00400036Updated Nov 16, 2006

Dietary Fish Protein in Subjects With Insulin Resistance

A Phase 2 interventional study of Cod protein NCEP-diet in Insulin Resistance and Type 2 Diabetes, sponsored by Laval University. Completed at 1 site in Canada. Open to participants aged 35 Years to 65 Years. Per ClinicalTrials.gov, last updated 2006-11-16.

Sponsored by Laval University · Phase 2, Interventional, and Prevention

Phase
Phase 2
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
35 Years to 65 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • 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
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 24 is below the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Laval University is the lead sponsor of 371 studies on the registry; 68 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
35 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
24 participants

Interventions

  • BehavioralCod protein NCEP-diet
06

What researchers measure

Primary outcomes

  1. Insulin sensitivity at 4 weeks

  2. Insulin signaling in skeletal muscle at 4 weeks

Secondary outcomes

  1. plasma lipids and lipoproteins at 4 weeks

  2. plasma inflammatory markers at 4 weeks

  3. glucose tolerance at 4 weeks

07

Study locations

1 site
  • Laval University
    Quebec city, Quebec G1K 7P4, Canada
08

References and documents

Publications

  • 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. PubMed 17682120 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 16, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00400036
Lead sponsor
Laval University
Collaborators
Canadian Institutes of Health Research (CIHR)
First posted
Nov 16, 2006
Start date
Feb 2004
Completion
Dec 2005
Last update
Nov 16, 2006

Study contacts

Helene Jacques, PhD
principal investigator · Laval University
Andre Marette, PhD
principal investigator · Laval University
Stanley J Weisnagel, MD / FRCPC
principal investigator · Laval University
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Nov 2006. You cannot join it, but the record below documents what was studied.

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