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

University of Leipzig

Status and phase: Completed; Phase 4

Conditions: Hypertension

Treatments: Dietary Supplement: dark chocolate 6 g/day; Dietary Supplement: dark chocolate 25 g/day

Study type: Interventional

Funder types: Other

Identifiers

NCT00661986

Leipzig chocolate

Details and patient eligibility

About

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).

Enrollment: 102 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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102 participants in 2 patient groups

1

Experimental group

Description:

dark chocolate 6 g/day

Treatment:

Dietary Supplement: dark chocolate 6 g/day

2

Active Comparator group

Description:

dark chocolate 25 g/day

Treatment:

Dietary Supplement: dark chocolate 25 g/day