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Trials / Completed

CompletedNCT01215903

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

Status
Completed
Phase
Phase 2
Study type
Interventional
Enrollment
21 (actual)
Sponsor
Laval University · Academic / Other
Sex
All
Age
40 Years – 70 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

TypeNameDescription
DIETARY_SUPPLEMENTFish gelatin and omega-3 polyunsaturated fatty acid
DIETARY_SUPPLEMENTOmega-3 polyunsaturated fatty acid

Timeline

Start date
2007-11-01
Primary completion
2009-05-01
Completion
2009-05-01
First posted
2010-10-07
Last updated
2010-10-25

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT01215903. Inclusion in this directory is not an endorsement.

Fish Gelatin Supplement and Omega-3 Supplement in Obese or Overweight Subjects With Insulin Resistance (NCT01215903) · Clinical Trials Directory