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OpenTrials
Completed

NCT Number: NCT01947712

Effect of Polyphenols on Peripheral Vascular Disease.

Peripheral arterial disease (PAD) is a clinical setting characterized by an exceptionally high risk for cardiovascular events. Oxidative stress seems to play a role in impairing flow-mediated dilation (FMD) and contributing to atherosclerosis in patients with PAD. Cocoa seems to exert artery dilatation via oxidative stress inhibition.

OBJECTIVES: To investigate whether in PAD patients, dark chocolate elicits artery dilatation via down-regulation of NOX2, the catalytic core of NADPH oxidase.

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Key information

Age range

20 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Sapienza University of Rome, I Clinica Medica, Research Tower

Rome, 00161, Italy

About this study

Atherosclerosis represents the major cause of worldwide death; it is a complex phenomenon that encompasses the intricate interplay of classic cardiovascular risk factors, oxidative stress and inflammation.

Peripheral artery disease (PAD) is a clinical setting that well represents the model of widespread atherosclerosis. PAD affects 20% of patients over the age of 75. Furthermore, PAD patients are at an exceptionally high risk for cardiovascular events and the majority will eventually die of a cardiac or cerebrovascular etiology.

Polyphenol could represent a novel therapeutic strategy to counteract atherosclerosis. During the last decades, a growing interest in polyphenols resulted from prospective and epidemiological studies that showed the beneficial effects of these substances on human health. In particular, polyphenols exert their beneficial effect by inhibition of NADPH oxidase (NOX2), an enzyme directly involved in atherosclerosis; thus, the activation of this enzyme leads to an enhanced production of oxidative stress and inflammatory processes.

The objective of this study is to evaluate the effect of polyphenols on oxidative stress and inflammation and on surrogate markers of atherosclerosis in PAD patients. Polyphenols, inhibiting NOX2-mediated oxidative stress and immune-mediated process, could represent a novel therapy to reduce the high risk of cardiovascular events in PAD.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

dark chocolate with crossover to milk chocolate

Dietary Supplement

40 g/d of dark chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of milk chocolate for 4 weeks

milk chocolate with crossover to dark chocolate

Dietary Supplement

40 g/d of milk chocolate for 4 weeks followed by wash-out (1 week) and by 40 g/d of dark chocolate for 4 weeks.

Primary outcomes

  1. endothelial function assessed by flow mediated dilation (FMD)

    Time frame: 2 hours after (dark or milk) chocolate ingestion

  2. endothelial function assessed by flow mediated dilation (FMD)

    Time frame: after 30 days of (dark or milk) chocolate ingestion

Secondary outcomes

  1. Oxidative stress markers

    Time frame: 2 hours after (dark or milk) chocolate ingestion

    Oxidative stress markers: sNOX2dp, Isoprostanes, NOx

  2. Maximal walking distance

    Time frame: 2 hours after (dark or milk) chocolate ingestion

  3. Ankle Brachial Index (ABI)

    Time frame: 2 hours after (dark or milk) chocolate ingestion

  4. Oxidative stress markers

    Time frame: after 30 days of (dark or milk) chocolate ingestion

    Oxidative stress markers: sNOX2dp, Isoprostanes, NOx

  5. Maximal walking distance

    Time frame: after 30 days of (dark or milk) chocolate ingestion

  6. Ankle Brachial Index (ABI)

    Time frame: after 30 days of (dark or milk) chocolate ingestion

Sponsors and collaborators

Lead sponsor

University of Roma La Sapienza

Other

Registry information

Official study title

Effect of Dark Chocolate on Endothelial Function and Oxidative Stress in Patients With Peripheral Vascular Disease.

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Sep 20, 2013
Registry last updated
Sep 20, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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