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

The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile

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.

Study Overview

• Status: Completed
• Conditions: Insulin Resistance; Type 2 Diabetes
• Intervention / Treatment: Dietary supplement: Fish gelatin and omega-3 polyunsaturated fatty acid; Dietary supplement: Omega-3 polyunsaturated fatty acid

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 Type: Interventional
• Enrollment (Actual): 21
• Phase: Phase 2

Contacts and Locations

Study Locations

• Canada
  • Quebec, Canada, G1V 0A6
    • Laval University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 38 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Fish gelatin and omega-3	Dietary supplement: Fish gelatin and omega-3 polyunsaturated fatty acid
Experimental: Omega-3	Dietary supplement: Omega-3 polyunsaturated fatty acid

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Insulin sensitivity	At 8 weeks
Plasma lipids and lipoproteins	at 8 weeks
Blood pressure	At 8 weeks
Plasma and serum inflammatory markers	At 8 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Glucose tolerance	At 8 weeks
Energy intake	At 8 weeks
Fatty acids of phospholipids in skeletal muscle	At 8 weeks

Collaborators and Investigators

• Sponsor: Laval University
• Collaborators: University of Guelph; Advance Foods and Materials Network; Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities); Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements); Kenney & Ross
• Investigators: Principal Investigator: Helene Jacques, PhD, Laval University; Principal Investigator: John S Weisnagel, MD/FRCPC, Laval University

Study record dates

Study Major Dates

• Study Start: November 1, 2007
• Primary Completion (Actual): May 1, 2009
• Study Completion (Actual): May 1, 2009

Study Registration Dates

• First Submitted: October 5, 2010
• First Submitted That Met QC Criteria: October 6, 2010
• First Posted (Estimate): October 7, 2010

Study Record Updates

• Last Update Posted (Estimate): October 25, 2010
• Last Update Submitted That Met QC Criteria: October 22, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Hyperinsulinism; Insulin Resistance
• Other Study ID Numbers: SIRUL-85742