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
1 other identifier
interventional
21
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Nov 2007
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
October 5, 2010
CompletedFirst Posted
Study publicly available on registry
October 7, 2010
CompletedOctober 25, 2010
October 1, 2010
1.5 years
October 5, 2010
October 22, 2010
Conditions
Outcome Measures
Primary Outcomes (4)
Insulin sensitivity
At 8 weeks
Plasma lipids and lipoproteins
at 8 weeks
Blood pressure
At 8 weeks
Plasma and serum inflammatory markers
At 8 weeks
Secondary Outcomes (3)
Glucose tolerance
At 8 weeks
Energy intake
At 8 weeks
Fatty acids of phospholipids in skeletal muscle
At 8 weeks
Study Arms (2)
Fish gelatin and omega-3
EXPERIMENTALOmega-3
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Laval Universitylead
- Advance Foods and Materials Networkcollaborator
- Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)collaborator
- University of Guelphcollaborator
- Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements)collaborator
- Kenney & Rosscollaborator
Study Sites (1)
Laval University
Québec, Quebec, G1V 0A6, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Helene Jacques, PhD
Laval University
- PRINCIPAL INVESTIGATOR
Andre Marette, PhD
Laval University
- PRINCIPAL INVESTIGATOR
John S Weisnagel, MD/FRCPC
Laval University
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
October 5, 2010
First Posted
October 7, 2010
Study Start
November 1, 2007
Primary Completion
May 1, 2009
Study Completion
May 1, 2009
Last Updated
October 25, 2010
Record last verified: 2010-10