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

Hypertension Clinical Trial

Official title:

Featuring Treated Hypertensive Patients Who Improve Endothelial Function After Dark Chocolate

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01314924
• Other study ID #: CHOC-70
• Status: Completed
• Phase: Phase 4
• First received: March 14, 2011
• Last updated: January 10, 2012
• Start date: January 2011
• Est. completion date: September 2011

Study information

• Verified date: January 2012
• Source: Hospital Universitario Pedro Ernesto
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Hypertension

Intervention

Dietary Supplement:
• Dark chocolate
70% cocoa

Locations

Country	Name	City	State
Brazil	Hospital Universitario Pedro Ernesto	Rio de Janeiro	RJ

Sponsors (2)

Lead Sponsor	Collaborator
Hospital Universitario Pedro Ernesto	Rio de Janeiro State Research Supporting Foundation (FAPERJ)

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Endothelial function	Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery	One week	No
Secondary	Blood pressure	Systolic and diastolic blood pressure levels evaluated by an automatic device	One week	No
Secondary	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	No