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

This study has been completed.
Sponsor:
Collaborator:
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Information provided by (Responsible Party):
Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier:
NCT01314924
First received: March 14, 2011
Last updated: January 10, 2012
Last verified: January 2012

March 14, 2011
January 10, 2012
January 2011
August 2011   (final data collection date for primary outcome measure)
Endothelial function [ Time Frame: One week ] [ Designated as safety issue: No ]
Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery
Same as current
Complete list of historical versions of study NCT01314924 on ClinicalTrials.gov Archive Site
  • Blood pressure [ Time Frame: One week ] [ Designated as safety issue: No ]
    Systolic and diastolic blood pressure levels evaluated by an automatic device
  • Central hemodynamic parameters [ Time Frame: One week ] [ Designated as safety issue: No ]
    Aortic systolic blood pressure and pulse pressure evaluated by SphygmoCor. Vascular stiffness parameters such as augmentation pressure and augmentation index will also be evaluated.
Same as current
Not Provided
Not Provided
 
Effects of Acute Ingestion of Dark Chocolate on Endothelial Function in Hypertensive Patients
Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

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.

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).

Interventional
Phase 4
Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Hypertension
Dietary Supplement: Dark chocolate
70% cocoa
Other Name: Cocoa
  • Experimental: Responders
    Patients who present an increase in flow-mediated dilation of brachial artery.
    Intervention: Dietary Supplement: Dark chocolate
  • Experimental: Non responders
    Patients who do not present an increase in flow-mediated dilation of brachial artery.
    Intervention: Dietary Supplement: Dark chocolate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
21
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
40 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01314924
CHOC-70
Yes
Mario Fritsch Neves, Hospital Universitario Pedro Ernesto
Hospital Universitario Pedro Ernesto
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Principal Investigator: Jenifer d"El-Rei, MSc State University of Rio de Janeiro
Hospital Universitario Pedro Ernesto
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP