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

This study has been completed.
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 Limited, Nova Scotia (in-kind support: Fish gelatin)
Information provided by:
Laval University
ClinicalTrials.gov Identifier:
NCT01215903
First received: October 5, 2010
Last updated: October 22, 2010
Last verified: October 2010
  Purpose

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 Intervention 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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Insulin sensitivity [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
  • Plasma lipids and lipoproteins [ Time Frame: at 8 weeks ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
  • Plasma and serum inflammatory markers [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose tolerance [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
  • Energy intake [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]
  • Fatty acids of phospholipids in skeletal muscle [ Time Frame: At 8 weeks ] [ Designated as safety issue: No ]

Enrollment: 21
Study Start Date: November 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01215903

Locations
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 Limited, Nova Scotia (in-kind support: Fish gelatin)
Investigators
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

No publications provided

Responsible Party: Helene Jacques, PhD, Laval University
ClinicalTrials.gov Identifier: NCT01215903     History of Changes
Other Study ID Numbers: SIRUL-85742
Study First Received: October 5, 2010
Last Updated: October 22, 2010
Health Authority: Canada: Advanced Foods and Materials Network
Canada: Ethics Review Committee

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Insulin Resistance
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Hyperinsulinism

ClinicalTrials.gov processed this record on August 20, 2014