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

NCT ID: NCT00661986

Last Updated: 2010-02-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

102 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-02-29

Study Completion Date

2009-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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1

dark chocolate 6 g/day

Group Type EXPERIMENTAL

dark chocolate 6 g/day

Intervention Type DIETARY_SUPPLEMENT

dark chocolate 6 g/day

2

dark chocolate 25 g/day

Group Type ACTIVE_COMPARATOR

dark chocolate 25 g/day

Intervention Type DIETARY_SUPPLEMENT

dark chocolate 25 g/day

Interventions

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dark chocolate 6 g/day

dark chocolate 6 g/day

Intervention Type DIETARY_SUPPLEMENT

dark chocolate 25 g/day

dark chocolate 25 g/day

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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University of Leipzig

Other Identifiers

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Leipzig chocolate

Identifier Type: -

Identifier Source: org_study_id

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