NCT00661986

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).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
102

participants targeted

Target at P25-P50 for phase_4 hypertension

Timeline
Completed

Started Feb 2008

Shorter than P25 for phase_4 hypertension

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 17, 2008

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 21, 2008

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2009

Completed
Last Updated

February 2, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

April 17, 2008

Last Update Submit

February 1, 2010

Conditions

Hypertension

Outcome Measures

Primary Outcomes (1)

  • change in mean ambulatory arterial blood pressure

    3 months

Secondary Outcomes (2)

  • change in weight and BMI

    3 months

  • change in various lab parameters

    3 months

Study Arms (2)

1

EXPERIMENTAL

dark chocolate 6 g/day

Dietary Supplement: dark chocolate 6 g/day

2

ACTIVE COMPARATOR

dark chocolate 25 g/day

Dietary Supplement: dark chocolate 25 g/day

Interventions

dark chocolate 6 g/dayDIETARY_SUPPLEMENT

dark chocolate 6 g/day

1
dark chocolate 25 g/dayDIETARY_SUPPLEMENT

dark chocolate 25 g/day

2

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 17, 2008

First Posted

April 21, 2008

Study Start

February 1, 2008

Primary Completion

May 1, 2009

Study Completion

May 1, 2009

Last Updated

February 2, 2010

Record last verified: 2010-01