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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00661986
Recruitment Status : Completed
First Posted : April 21, 2008
Last Update Posted : February 2, 2010
Sponsor:
Information provided by:
University of Leipzig

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Hypertension Dietary Supplement: dark chocolate 6 g/day Dietary Supplement: dark chocolate 25 g/day Phase 4

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients
Study Start Date : February 2008
Actual Primary Completion Date : May 2009
Actual Study Completion Date : May 2009

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Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. change in mean ambulatory arterial blood pressure [ Time Frame: 3 months ]

Secondary Outcome Measures :
  1. change in weight and BMI [ Time Frame: 3 months ]
  2. change in various lab parameters [ Time Frame: 3 months ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Steffen Desch, University of Leipzig
ClinicalTrials.gov Identifier: NCT00661986    
Other Study ID Numbers: Leipzig chocolate
First Posted: April 21, 2008    Key Record Dates
Last Update Posted: February 2, 2010
Last Verified: January 2010
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases