NCT00125866

Brief Summary

The purpose of this study is to compare the effects on blood pressure of a daily intake of a flavonoid-rich cocoa drink with that of the same drink from which the flavonoids have been largely extracted.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Sep 2005

Shorter than P25 for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 2, 2005

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2005

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2006

Completed
Last Updated

May 28, 2015

Status Verified

April 1, 2007

First QC Date

July 29, 2005

Last Update Submit

May 27, 2015

Conditions

Hypertension

Keywords

randomised double blind trialblood pressurecocoa flavonoids

Outcome Measures

Primary Outcomes (1)

  • Difference in mean 24 hour ambulatory blood pressure

Secondary Outcomes (5)

  • Difference in cholesterol

  • Difference in glucose

  • Difference in insulin

  • Difference in echocardiogram

  • Difference in pulse wave velocity

Interventions

Flavonoid rich or flavonoid depleted chocolate drinkBEHAVIORAL

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females of any age.
  • Diagnosis of hypertension and on antihypertensive treatment.
  • Stable blood pressure that has reached the British Hypertension Society (BHS) audit standard (\<150/90mmHg).

You may not qualify if:

  • Participation in another clinical trial.
  • Any reason to suspect that the patient will not comply with drinking a chocolate beverage every day for the trial duration.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London

Paddington, London, W2 1PG, United Kingdom

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Neil R Poulter

    Imperial College London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 29, 2005

First Posted

August 2, 2005

Study Start

September 1, 2005

Study Completion

January 1, 2006

Last Updated

May 28, 2015

Record last verified: 2007-04

Locations

GB(1)