Effect of Polyphenols on Peripheral Vascular Disease.
Peripheral Arterial Disease
About this trial
This is an interventional basic science trial for Peripheral Arterial Disease focused on measuring Peripheral arterial disease, Oxidative stress, Cocoa, polyphenols, NADPH oxidase
Eligibility Criteria
Inclusion Criteria:
Every PAD patient to be enrolled in the study had:
- claudication (defined as leg pain on walking, disappearing within 10 minutes of standing, of presumed atherosclerotic origin) and
- ankle/brachial index (ABI), that was assessed as ankle/arm systolic blood pressure ratio by Doppler ultrasonography <0.90 on the worst leg at rest.
Patients had to be in stable conditions without abrupt changes of ABI (>20%) in the last month before the enrolment.
Exclusion Criteria:
Subjects were excluded from the study if they had liver insufficiency, serious renal disorders (serum creatinine>2.8 mg/dL), acute stroke, acute myocardial infarction, deep venous thrombosis or if they were current smokers or were taking antioxidants.
Sites / Locations
- Sapienza University of Rome, I Clinica Medica, Research Tower
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Active Comparator
milk chocolate
dark chocolate
dosage form: orally given dosage:40 g milk chocolate (≤35% cocoa) frequency and duration: 40 g/day for one month
dosage form: orally given dosage:40 g dark chocolate (≥85% cocoa) frequency and duration: 40 g/day for one month