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

NCT ID: NCT01215903

Last Updated: 2010-10-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-11-30

Study Completion Date

2009-05-31

Brief Summary

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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

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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.

Conditions

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Insulin Resistance Type 2 Diabetes

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Fish gelatin and omega-3

Group Type EXPERIMENTAL

Fish gelatin and omega-3 polyunsaturated fatty acid

Intervention Type DIETARY_SUPPLEMENT

Omega-3

Group Type EXPERIMENTAL

Omega-3 polyunsaturated fatty acid

Intervention Type DIETARY_SUPPLEMENT

Interventions

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Fish gelatin and omega-3 polyunsaturated fatty acid

Intervention Type DIETARY_SUPPLEMENT

Omega-3 polyunsaturated fatty acid

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Advance Foods and Materials Network

OTHER

Sponsor Role collaborator

Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)

UNKNOWN

Sponsor Role collaborator

University of Guelph

OTHER

Sponsor Role collaborator

Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements)

UNKNOWN

Sponsor Role collaborator

Kenney & Ross

OTHER

Sponsor Role collaborator

Laval University

OTHER

Sponsor Role lead

Responsible Party

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Laval University

Principal Investigators

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Helene Jacques, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

Andre Marette, PhD

Role: PRINCIPAL_INVESTIGATOR

Laval University

John S Weisnagel, MD/FRCPC

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval University

Québec, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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SIRUL-85742

Identifier Type: -

Identifier Source: org_study_id