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Completed

NCT Number: NCT01314924

Effects of Acute Ingestion of Dark Chocolate on Endothelial Function in Hypertensive Patients

We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function.

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario Pedro Ernesto

Rio de Janeiro, 20551-030, Brazil

About this study

Recent findings indicate an inverse relationship between cardiovascular disease and consumption of flavonoids. We aimed to identify clinical and vascular parameters of treated hypertensive patients who present beneficial effects of dark chocolate for one-week period on vascular function. Twenty-one hypertensive patients in drug therapy, both genders, aged 40-65 years, were included in a prospective study with measurement of blood pressure, brachial flow-mediated dilatation (FMD), peripheral arterial tonometry (EndoPAT) and central hemodynamic parameters by SphygmoCor. After seven days of eating dark chocolate (70% cocoa) 75g/day, the clinical and vascular evaluation were repeated. Patients were divided into two groups according to the response in FMD: responders (increase in FMD, n=12) and non-responders (no improvement in FMD, n=9).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Previous diagnosis of hypertension
  • Use of one or two antihypertensive drugs
  • Systolic blood pressure between 130 and 160 mmHg
  • Diastolic blood pressure between 85 and 100 mmHg

Exclusion criteria

  • Secondary hypertension
  • Diabetes mellitus
  • Body mass index > 35kg/m2
  • Chronic kidney disease
  • Known coronary artery disease
  • Previous stroke

Treatment and study plan

Dark chocolate

Dietary Supplement

70% cocoa

Other names: Cocoa

Primary outcomes

  1. Endothelial function

    Time frame: One week

    Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery

Secondary outcomes

  1. Blood pressure

    Time frame: One week

    Systolic and diastolic blood pressure levels evaluated by an automatic device

  2. Central hemodynamic parameters

    Time frame: One week

    Aortic systolic blood pressure and pulse pressure evaluated by SphygmoCor. Vascular stiffness parameters such as augmentation pressure and augmentation index will also be evaluated.

Sponsors and collaborators

Lead sponsor

Hospital Universitario Pedro Ernesto

Other

Collaborators

  • Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Registry information

Official study title

Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Mar 15, 2011
Registry last updated
Jan 11, 2012

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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