Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients

February 1, 2010 updated by: University of Leipzig
Low habitual intake of low-dose dark chocolate (6 g/day) has been shown to have a beneficial effect on arterial blood pressure in one previous study. The trial will assess if ingestion of a higher but still moderate dose (25 g/day) over 3 months will have a more pronounced effect. The population will consist of cardiovascular high-risk patients only (who will potentially benefit most from blood-pressure lowering).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

102

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age > 18 years
  • mean ambulatory blood pressure 125-146 mmHg and/or 80-89 mmHg
  • high cardiovascular risk profile (one or more of the following: CAD, PAD, carotid stenosis, diabetes)
  • informed consent

Exclusion Criteria:

  • habituary intake of dark chocolate or cocoa products
  • mean ambulatory blood pressure 147 mmHg or greater and/or 90 mmHg or greater
  • pregnancy
  • uncontrolled diabetes
  • severe comorbidity
  • change in blood pressure medication within last 6 weeks
  • participation in another trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
dark chocolate 6 g/day
Dietary supplement: dark chocolate 6 g/day
dark chocolate 6 g/day
Active Comparator: 2
dark chocolate 25 g/day
Dietary supplement: dark chocolate 25 g/day
dark chocolate 25 g/day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
change in mean ambulatory arterial blood pressure
Time Frame: 3 months
3 months

Secondary Outcome Measures

Outcome Measure
Time Frame
change in weight and BMI
Time Frame: 3 months
3 months
change in various lab parameters
Time Frame: 3 months
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

May 1, 2009

Study Completion (Actual)

May 1, 2009

Study Registration Dates

First Submitted

April 17, 2008

First Submitted That Met QC Criteria

April 17, 2008

First Posted (Estimate)

April 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2010

Last Update Submitted That Met QC Criteria

February 1, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Leipzig chocolate

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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