NCT01314924

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_4 hypertension

Timeline
Completed

Started Jan 2011

Shorter than P25 for phase_4 hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

January 11, 2012

Status Verified

January 1, 2012

Enrollment Period

7 months

First QC Date

March 14, 2011

Last Update Submit

January 10, 2012

Conditions

Hypertension

Keywords

HypertensionEndothelial dysfunctionVascular stiffnessUse of one or two antihypertensive drugs

Outcome Measures

Primary Outcomes (1)

  • Endothelial function

    Endothelial function evaluated by peripheral arterial tonometry and by flow-mediated dilation of brachial artery

    One week

Secondary Outcomes (2)

  • Blood pressure

    One week

  • Central hemodynamic parameters

    One week

Study Arms (2)

Responders

EXPERIMENTAL

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

Dietary Supplement: Dark chocolate

Non responders

EXPERIMENTAL

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

Dietary Supplement: Dark chocolate

Interventions

Dark chocolateDIETARY_SUPPLEMENT

70% cocoa

Also known as: Cocoa
Non respondersResponders

Eligibility Criteria

Age40 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Secondary hypertension
  • Diabetes mellitus
  • Body mass index \> 35kg/m2
  • Chronic kidney disease
  • Known coronary artery disease
  • Previous stroke

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitario Pedro Ernesto

Rio de Janeiro, Rio de Janeiro, 20551-030, Brazil

Location

MeSH Terms

Conditions

Hypertension

Interventions

Chocolate

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jenifer d"El-Rei, MSc

    State University of Rio de Janeiro

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 14, 2011

First Posted

March 15, 2011

Study Start

January 1, 2011

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

January 11, 2012

Record last verified: 2012-01

Locations

BR(1)