Clinical trial NCT00400036: Dietary Fish Protein in Subjects With Insulin Resistance
Official title: Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: 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
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2006-11-16
Enrollment: 24
Sex: ALL
Minimum age (years): 35
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Insulin sensitivity at 4 weeks
measure: Insulin signaling in skeletal muscle at 4 weeks
Secondary outcomes:
measure: plasma lipids and lipoproteins at 4 weeks
measure: plasma inflammatory markers at 4 weeks
measure: glucose tolerance at 4 weeks
Other outcomes:
Locations:
city: Quebec city
country: Canada
facility: Laval University
state: Quebec
Study officials:
affiliation: Laval University
name: Helene Jacques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Andre Marette, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Stanley J Weisnagel, MD / FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.