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

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).

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Key information

Conditions

Hypertension Cardiovascular Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

dark chocolate 6 g/day

Dietary Supplement

dark chocolate 6 g/day

dark chocolate 25 g/day

Dietary Supplement

dark chocolate 25 g/day

Primary outcomes

change in mean ambulatory arterial blood pressure

Time frame: 3 months

Secondary outcomes

change in weight and BMI

Time frame: 3 months
change in various lab parameters

Time frame: 3 months

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Apr 21, 2008
Registry last updated: Feb 2, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed