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

This study has been completed.
Sponsor:
Information provided by:
University of Leipzig
ClinicalTrials.gov Identifier:
NCT00661986
First received: April 17, 2008
Last updated: February 1, 2010
Last verified: January 2010
History of Changes
  Purpose

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 Intervention Phase
Hypertension
 Dietary Supplement: dark chocolate 6 g/day
Dietary Supplement: dark chocolate 25 g/day
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Different Dosages of Dark Chocolate on Arterial Blood Pressure in Cardiovascular High-risk Patients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Leipzig:

Primary Outcome Measures:
  • change in mean ambulatory arterial blood pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • change in weight and BMI [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • change in various lab parameters [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Enrollment: 102
Study Start Date: February 2008
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Steffen Desch, University of Leipzig
ClinicalTrials.gov Identifier: NCT00661986     History of Changes
Other Study ID Numbers: Leipzig chocolate
Study First Received: April 17, 2008
Last Updated: February 1, 2010
Health Authority: Germany: Ethics Commission

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013