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

NCT ID: NCT01314924

Last Updated: 2012-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-01-31

Study Completion Date

2011-09-30

Brief Summary

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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

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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).

Conditions

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Hypertension

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Responders

Patients who present an increase in flow-mediated dilation of brachial artery.

Group Type EXPERIMENTAL

Dark chocolate

Intervention Type DIETARY_SUPPLEMENT

70% cocoa

Non responders

Patients who do not present an increase in flow-mediated dilation of brachial artery.

Group Type EXPERIMENTAL

Dark chocolate

Intervention Type DIETARY_SUPPLEMENT

70% cocoa

Interventions

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Dark chocolate

70% cocoa

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Cocoa

Eligibility Criteria

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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
Minimum Eligible Age

40 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Rio de Janeiro State Research Supporting Foundation (FAPERJ)

OTHER_GOV

Sponsor Role collaborator

Hospital Universitario Pedro Ernesto

OTHER

Sponsor Role lead

Responsible Party

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Mario Fritsch Neves

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jenifer d"El-Rei, MSc

Role: PRINCIPAL_INVESTIGATOR

State University of Rio de Janeiro

Locations

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Hospital Universitario Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CHOC-70

Identifier Type: -

Identifier Source: org_study_id

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