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

Study Overview
=================
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).

Official Title
-----------------
Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Dietary Supplement: Dark chocolate


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Responders<br>Patients who present an increase in flow-mediated dilation of brachial artery. | Dietary Supplement: Dark chocolate<br>* 70% cocoa<br>* Other names: Cocoa;|
| Experimental: Non responders<br>Patients who do not present an increase in flow-mediated dilation of brachial artery. | Dietary Supplement: Dark chocolate<br>* 70% cocoa<br>* Other names: Cocoa;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery | One week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Systolic and diastolic blood pressure levels evaluated by an automatic device | One week | 
| Central hemodynamic parameters | Aortic systolic blood pressure and pulse pressure evaluated by SphygmoCor. Vascular stiffness parameters such as augmentation pressure and augmentation index will also be evaluated. | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Endothelial dysfunction, Vascular stiffness, Use of one or two antihypertensive drugs