Clinical trial NCT01215903: Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance
Official title: The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Insulin Resistance
Type 2 Diabetes
Lead sponsor: Laval University
Sponsor class: OTHER
Collaborators: name: Advance Foods and Materials Network
name: Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities)
name: University of Guelph
name: Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements)
name: Kenney & Ross
First posted: 2010-10-07
Enrollment: 21
Sex: ALL
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Insulin sensitivity
timeFrame: At 8 weeks
measure: Plasma lipids and lipoproteins
timeFrame: at 8 weeks
measure: Blood pressure
timeFrame: At 8 weeks
measure: Plasma and serum inflammatory markers
timeFrame: At 8 weeks
Secondary outcomes:
measure: Glucose tolerance
timeFrame: At 8 weeks
measure: Energy intake
timeFrame: At 8 weeks
measure: Fatty acids of phospholipids in skeletal muscle
timeFrame: At 8 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Laval University
Study officials:
affiliation: Laval University
name: Helene Jacques, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: Andre Marette, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Laval University
name: John S Weisnagel, MD/FRCPC
role: PRINCIPAL_INVESTIGATOR
References: