Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Help guide our efforts to modernize ClinicalTrials.gov.
Send us your comments by March 14, 2020.

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

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

Layout table for study information
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

Resource links provided by the National Library of Medicine


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




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 ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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

Layout table for additonal information
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:
Layout table for MeSH terms
Hypertension
Vascular Diseases
Cardiovascular Diseases