Dietary Fish Protein in Subjects With Insulin Resistance

Type 2 Diabetes Clinical Trial

Official title:

Assessment of Insulin Sensitivity in Insulin-Resistant Subjects Fed Fish Protein

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00400036
• Other study ID #: MOP-64443
• Status: Completed
• Phase: Phase 2
• First received: November 14, 2006
• Last updated: November 14, 2006
• Start date: February 2004
• Est. completion date: December 2005

Study information

• Verified date: November 2006
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review CommitteeCanada: Canadian Institutes of Health Research
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Insulin Resistance
• Type 2 Diabetes

Intervention

Behavioral:
• Cod protein NCEP-diet

Locations

Country	Name	City	State
Canada	Laval University	Quebec city	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity at 4 weeks
Primary	Insulin signaling in skeletal muscle at 4 weeks
Secondary	plasma lipids and lipoproteins at 4 weeks
Secondary	plasma inflammatory markers at 4 weeks
Secondary	glucose tolerance at 4 weeks