We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01215903
Recruitment Status : Completed
First Posted : October 7, 2010
Last Update Posted : October 25, 2010
Sponsor:
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
Information provided by:
Laval University

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Type 2 Diabetes Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid Dietary Supplement: Omega-3 polyunsaturated fatty acid Phase 2

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 21 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile
Study Start Date : November 2007
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Insulin sensitivity [ Time Frame: At 8 weeks ]
  2. Plasma lipids and lipoproteins [ Time Frame: at 8 weeks ]
  3. Blood pressure [ Time Frame: At 8 weeks ]
  4. Plasma and serum inflammatory markers [ Time Frame: At 8 weeks ]

Secondary Outcome Measures :
  1. Glucose tolerance [ Time Frame: At 8 weeks ]
  2. Energy intake [ Time Frame: At 8 weeks ]
  3. Fatty acids of phospholipids in skeletal muscle [ Time Frame: At 8 weeks ]

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01215903


Locations
Layout table for location information
Canada
Laval University
Quebec, Canada, G1V 0A6
Sponsors and Collaborators
Laval University
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
Investigators
Layout table for investigator information
Principal Investigator: Helene Jacques, PhD Laval University
Principal Investigator: Andre Marette, PhD Laval University
Principal Investigator: John S Weisnagel, MD/FRCPC Laval University
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Helene Jacques, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01215903    
Other Study ID Numbers: SIRUL-85742
First Posted: October 7, 2010    Key Record Dates
Last Update Posted: October 25, 2010
Last Verified: October 2010
Additional relevant MeSH terms:
Layout table for MeSH terms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases