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

This study has been completed.
Sponsor:
Collaborators:
Advanced Foods and Materials Network, Canada (funding)
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

October 5, 2010
October 22, 2010
November 2007
May 2009   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT01215903 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Insulin Resistance
  • Type 2 Diabetes
  • Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid
  • Dietary Supplement: Omega-3 polyunsaturated fatty acid
  • Experimental: Fish gelatin and omega-3
    Intervention: Dietary Supplement: Fish gelatin and omega-3 polyunsaturated fatty acid
  • Experimental: Omega-3
    Intervention: Dietary Supplement: Omega-3 polyunsaturated fatty acid
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
May 2009
May 2009   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01215903
SIRUL-85742
Yes
Helene Jacques, PhD, Laval University
Laval University
  • Advanced Foods and Materials Network, Canada (funding)
  • 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)
Principal Investigator: Helene Jacques, PhD Laval University
Principal Investigator: Andre Marette, PhD Laval University
Principal Investigator: John S Weisnagel, MD/FRCPC Laval University
Laval University
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP