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

Type 2 Diabetes Clinical Trial

Official title:

The Beneficial Effects of Fish Nutrients on the Obesity-linked Metabolic Syndrome and Cardiovascular Risk Profile

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01215903
• Other study ID #: SIRUL-85742
• Status: Completed
• Phase: Phase 2
• First received: October 5, 2010
• Last updated: October 22, 2010
• Start date: November 2007
• Est. completion date: May 2009

Study information

• Verified date: October 2010
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Advanced Foods and Materials NetworkCanada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Insulin Resistance
• Type 2 Diabetes

Intervention

Dietary Supplement:
• Fish gelatin and omega-3 polyunsaturated fatty acid

• Omega-3 polyunsaturated fatty acid

Locations

Country	Name	City	State
Canada	Laval University	Quebec

Sponsors (6)

Lead Sponsor	Collaborator
Laval University	Advance Foods and Materials Network, Institut des Nutraceutiques et Aliments fonctionnels, Quebec (Clinical nutrition facilities), Kenney & Ross Limited, Nova Scotia (in-kind support: Fish gelatin), Ocean Nutrition Canada, Halifax (in-kind support: omega-3 supplements), University of Guelph

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin sensitivity		At 8 weeks	No
Primary	Plasma lipids and lipoproteins		at 8 weeks	No
Primary	Blood pressure		At 8 weeks	No
Primary	Plasma and serum inflammatory markers		At 8 weeks	No
Secondary	Glucose tolerance		At 8 weeks	No
Secondary	Energy intake		At 8 weeks	No
Secondary	Fatty acids of phospholipids in skeletal muscle		At 8 weeks	No