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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 22, 2014