The Effects of Dark Chocolate on Blood Pressure in Individuals With Mildly Elevated Blood Pressure (CHOKO)

May 1, 2014 updated by: Mikael Fogelholm, University of Helsinki

The Effects of Dark Chocolate on Blood Pressure in Mildly Hypertensive Individuals

The evidence linking chocolate with lowered blood pressure has been observed. However, the interventions have been short, at most 4 weeks. The aim of this study is to find out if the habitual consumption of dark chocolate for 8 weeks has an effect on blood pressure. Also, more insight to the mechanisms linking chocolate to individual healt-responses is needed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
    • Helsingin Yliopisto
      • Helsinki, Helsingin Yliopisto, Finland, 00014
        • University of Helsinki
    • Uusimaa
      • Helsinki, Uusimaa, Finland, 00290
        • Institute of clinical medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age 25-65 years
  • resting systolic pressure 140-159 mmHg or diastolic blood pressure 90-99 mmHg
  • BMI 25.0- 29.9

Exclusion Criteria:

  • smoking
  • regular medication for hypertension, cardiovascular disease, diabetes or asthma

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dark chocolate, dietary counselling
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Dietary supplement: Dark chocolate
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Active Comparator: Dietary counselling
Usual snacks are limited.
Dietary supplement: Dark chocolate
Mildly hypertensive subject will replace their usual snacks with with 50 g dark chocolate daily for a period of 8 weeks.
Other: Dietary counselling
Usual snacks are limited.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in systolic and diastolic blood pressure
Time Frame: 8 weeks
Usual daily snack is replaced by 50 g dark chocolate for a period of 8 weeks. During the control period, the same usual snack is limited in the diet, but without the replacement with the dark chocolate.
8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Ambulatory blood pressure
Time Frame: 8 weeks
8 weeks
Blood lipids, inflammation markers, plasma levels of cocoa polyphenols
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Helsinki

Collaborators

Fazer Group

Investigators

  • Principal Investigator: Mikael Fogelholm, Dr., University of Helsinki

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2012

Primary Completion (Actual)

January 1, 2014

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

May 1, 2014

First Submitted That Met QC Criteria

May 1, 2014

First Posted (Estimate)

May 5, 2014

Study Record Updates

Last Update Posted (Estimate)

May 5, 2014

Last Update Submitted That Met QC Criteria

May 1, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • HY-RAV-FAZ-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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