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

Phase 4

Completed

• Conditions: Hypertension
• Interventions: Dietary Supplement: Dark chocolate

• Registration Number: NCT01314924
• Lead Sponsor: Hospital Universitario Pedro Ernesto

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 Timeline

• Study Start: 2011-01
• Study First Submitted: 2011-03-14
• Study First Submitted QC: 2011-03-14
• Study First Posted: 2011-03-15
• Primary Completion: 2011-08
• Study Completion: 2011-09
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-10
• Last Update Posted: 2012-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Responders	Dark chocolate	Patients who present an increase in flow-mediated dilation of brachial artery.
Non responders	Dark chocolate	Patients who do not present an increase in flow-mediated dilation of brachial artery.

Primary Outcome Measures

Name	Time	Method
Endothelial function	One week	Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery

Secondary Outcome Measures

Name	Time	Method
Blood pressure	One week	Systolic and diastolic blood pressure levels evaluated by an automatic device
Central hemodynamic parameters	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.

Trial Locations

Locations (1)

Hospital Universitario Pedro Ernesto; 🇧🇷 Rio de Janeiro, RJ, Brazil