Metabolic Syndrome Clinical Trial
— EtherpathsOfficial title:
Effects of Polyphenols and Omega-3 Fatty Acids on Cardiovascular Rik Factors (Focusing on Postprandial Lipids Metabolism) in Subjects With High Risk for Type 2 Diabetes and Cardiovascular Diseases
Verified date | June 2013 |
Source | Federico II University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Italy: Ethics Committee |
Study type | Interventional |
The aim of this study is to explore if a 8-weeks dietary intervention with polyphenols and omega 3 fatty acids (alone or combined) may be effective on postprandial lipids metabolism and other cardiovascular risk factors in people at high cardiovascular risk.
Status | Completed |
Enrollment | 86 |
Est. completion date | June 2012 |
Est. primary completion date | June 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 70 Years |
Eligibility |
Inclusion Criteria: - bmi >25<35 kg/m2 - High waist circumference (men >102 cm, women >88 cm) + one the following components of metabolic syndrome : Fasting plasma triglycerides =150 mg/dl Fasting HDL-col <40 mg/dl (men) and <50 mg/dl (women) Fasting plasma glucose 100-125 mg/dl Exclusion Criteria: - Fasting plasma triglycerides =400 mg/dl and cholesterol >270 mg/dl - Cardiovascular events (AMI and/or stroke) in the last 6 months - Diabetes mellitus - Regular intensive physical activity - Kidney (serum creatinine >1.7 mg/dl) and liver (transaminases >double) - Hypolipidemic or antinflammatory drugs - Anemia (Hb <12 g/dl) or any other chronic disease |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Italy | Federico II University | Napoli | Naples |
Lead Sponsor | Collaborator |
---|---|
Federico II University |
Italy,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | incremental AUC after a test meal of triglycerides concentration in chylomicrons and VLDL fraction | 48 months | No | |
Secondary | insulin sensitivity | 48 months | No | |
Secondary | plasma and adipose tissue adipokines | 48 months | No | |
Secondary | endothelial function | 48 months | No |
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