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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Hypertension
 Dietary Supplement: Dark chocolate
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hospital Universitario Pedro Ernesto:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Enrollment: 21
Study Start Date: January 2011
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Responders
Patients who present an increase in flow-mediated dilation of brachial artery.
 Dietary Supplement: Dark chocolate
70% cocoa
Other Name: Cocoa
Experimental: Non responders
Patients who do not present an increase in flow-mediated dilation of brachial artery.
 Dietary Supplement: Dark chocolate
70% cocoa
Other Name: Cocoa

Detailed Description:

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).

  Eligibility

Ages Eligible for Study:   40 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01314924

Locations
Brazil
Hospital Universitario Pedro Ernesto
Rio de Janeiro, RJ, Brazil, 20551-030
Sponsors and Collaborators
Hospital Universitario Pedro Ernesto
Rio de Janeiro State Research Supporting Foundation (FAPERJ)
Investigators
Principal Investigator: Jenifer d"El-Rei, MSc State University of Rio de Janeiro
  More Information

No publications provided

Responsible Party: Mario Fritsch Neves, Associate Professor, Hospital Universitario Pedro Ernesto
ClinicalTrials.gov Identifier: NCT01314924     History of Changes
Other Study ID Numbers: CHOC-70
Study First Received: March 14, 2011
Last Updated: January 10, 2012
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Hospital Universitario Pedro Ernesto:
Hypertension
Endothelial dysfunction
Vascular stiffness
Use of one or two antihypertensive drugs

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Antihypertensive Agents
 Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on June 18, 2013