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

Primary Purpose

Insulin Resistance, Type 2 Diabetes

Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Fish gelatin and omega-3 polyunsaturated fatty acid
Omega-3 polyunsaturated fatty acid
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Insulin Resistance

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Laval University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Fish gelatin and omega-3

Omega-3

Arm Description

Outcomes

Primary Outcome Measures

Insulin sensitivity
Plasma lipids and lipoproteins
Blood pressure
Plasma and serum inflammatory markers

Secondary Outcome Measures

Glucose tolerance
Energy intake
Fatty acids of phospholipids in skeletal muscle

Full Information

First Posted
October 5, 2010
Last Updated
October 22, 2010
Sponsor
Laval University
Collaborators
Advance Foods and Materials Network, Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities), University of Guelph, Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements), Kenney & Ross
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1. Study Identification

Unique Protocol Identification Number
NCT01215903
Brief Title
Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance
Official Title
The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
November 2007 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
May 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Laval University
Collaborators
Advance Foods and Materials Network, Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities), University of Guelph, Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements), Kenney & Ross

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance, Type 2 Diabetes

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
21 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Fish gelatin and omega-3
Arm Type
Experimental
Arm Title
Omega-3
Arm Type
Experimental
Intervention Type
Dietary Supplement
Intervention Name(s)
Fish gelatin and omega-3 polyunsaturated fatty acid
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3 polyunsaturated fatty acid
Primary Outcome Measure Information:
Title
Insulin sensitivity
Time Frame
At 8 weeks
Title
Plasma lipids and lipoproteins
Time Frame
at 8 weeks
Title
Blood pressure
Time Frame
At 8 weeks
Title
Plasma and serum inflammatory markers
Time Frame
At 8 weeks
Secondary Outcome Measure Information:
Title
Glucose tolerance
Time Frame
At 8 weeks
Title
Energy intake
Time Frame
At 8 weeks
Title
Fatty acids of phospholipids in skeletal muscle
Time Frame
At 8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Helene Jacques, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Andre Marette, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
John S Weisnagel, MD/FRCPC
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University
City
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada

12. IPD Sharing Statement

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

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