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

Tracking Information

First Received Date ^ICMJE

March 14, 2011

Last Updated Date

January 10, 2012

Start Date ^ICMJE

January 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01314924 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

Brief Summary

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.

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).

Study Type ^ICMJE

Interventional

Study Phase

Phase 4

Study Design ^ICMJE

Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care

Condition ^ICMJE

Hypertension

Intervention ^ICMJE

Dietary Supplement: Dark chocolate

70% cocoa

Other Name: Cocoa

Study Arm (s)

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

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2011

Primary Completion Date

August 2011 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

40 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Brazil

Administrative Information

NCT Number ^ICMJE

NCT01314924

Other Study ID Numbers ^ICMJE

CHOC-70

Has Data Monitoring Committee

Yes

Responsible Party

Mario Fritsch Neves, Hospital Universitario Pedro Ernesto

Study Sponsor ^ICMJE

Hospital Universitario Pedro Ernesto

Collaborators ^ICMJE

Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Investigators ^ICMJE

Principal Investigator:

Jenifer d"El-Rei, MSc

State University of Rio de Janeiro

Information Provided By

Hospital Universitario Pedro Ernesto

Verification Date

January 2012

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

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