Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance

Phase 2

Completed

• Conditions: Insulin Resistance; Type 2 Diabetes
• Interventions: Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid; Dietary Supplement: Omega-3 polyunsaturated fatty acid

• Registration Number: NCT01215903
• Lead Sponsor: Laval University

Brief Summary

The present study was conducted to test whether a fish gelatin supplement combined with an omega-3 polyunsaturated fatty acid supplement can exert beneficial and sex-specific effects on insulin sensitivity, glucose tolerance, indicators of insulin secretion, blood pressure, lipid metabolism, inflammation and energy intake in obese or overweight insulin-resistant men and women. The investigators hypothesis is that fish gelatin improves insulin sensitivity, glucose tolerance, lipid profile and reduces inflammation in obese or overweight insulin-resistant men and women.

Detailed Description

An important number of recent epidemiological studies have demonstrated the beneficial effects of marine omega-3 polyunsaturated fatty acids (n-3 PUFA) on cardiovascular disease risk factors such as reduced triglycerides, decreased platelet aggregation, plaque stabilization, antiarrhythmic effects, and reduced blood pressure. Dietary fish protein has also been shown to improve insulin sensitivity by 30% in insulin-resistant obese or overweight human subjects. In addition, an increasing number of studies describe and demonstrate the physiological and metabolic variations between men and women in regard to CVD and their risk factors, including type 2 diabetes, but the data are still limited. In agreement with the recent findings, this study was conducted to evaluate the combined and synergistic effects of omega-3 and fish protein supplements on insulin sensitivity, blood pressure, lipid metabolism and inflammation in obese or overweight insulin-resistant men and women having some or all the metabolic syndrome criteria including a deteriorated lipid profile, high blood pressure and high waist circumference in a free living situation.

Study Timeline

• Study Start: 2007-11
• Primary Completion: 2009-05
• Study Completion: 2009-05
• Status Verified: 2010-10
• Study First Submitted: 2010-10-05
• Study First Submitted QC: 2010-10-06
• Study First Posted: 2010-10-07
• Last Update Submitted: 2010-10-22
• Last Update Posted: 2010-10-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

Inclusion Criteria

• overweight or obese (body mass index [BMI] between 25 and 40kg/m2)
• fasting plasma glucose below 7.0mmol/L and 2-h plasma glucose below 11.1mmol/L
• fasting plasma insulin above 90pmol/L

Exclusion Criteria

• Diabetes, chronic, metabolic or acute disease
• Major surgery within the last 3 months
• Significant weight loss (±10%) within the last 6 months
• Any medication-taking known to affect lipid of glucose metabolism
• Allergy, intolerance or dislike of fish
• Smokers

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Fish gelatin and omega-3	Fish gelatin and omega-3 polyunsaturated fatty acid	-
Omega-3	Omega-3 polyunsaturated fatty acid	-

Primary Outcome Measures

Name	Time	Method
Plasma and serum inflammatory markers	At 8 weeks
Insulin sensitivity	At 8 weeks
Plasma lipids and lipoproteins	at 8 weeks
Blood pressure	At 8 weeks

Secondary Outcome Measures

Name	Time	Method
Fatty acids of phospholipids in skeletal muscle	At 8 weeks
Energy intake	At 8 weeks
Glucose tolerance	At 8 weeks

Trial Locations

Locations (1)

Laval University; 🇨🇦 Quebec, Canada