Status:
COMPLETED
Effects of Dietary Polyphenols and ω-3 Fatty Acids on Cardiovascular Risk Factors in High Risk Subjects
Lead Sponsor:
Federico II University
Conditions:
Metabolic Syndrome
Eligibility:
All Genders
40-70 years
Phase:
NA
Brief Summary
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 cardiova...
Detailed Description
Fish consumption is associated with a lower cardiovascular risk and dietary supplementation with ω-3 fatty acids reduces plasma triglyceride levels. The mechanisms of action of ω-3 fatty acids are cur...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT01154478
Start Date
January 1 2010
End Date
June 1 2012
Last Update
June 19 2013
Active Locations (1)
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1
Federico II University
Napoli, Naples, Italy, 80131