Consumption of Chocolate in Pregnant Women. (CHOCENTA)

April 8, 2015 updated by: Laval University

Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.

The purpose of this study is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function in pregnant women at high risk for preeclampsia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Although numerous strategies have been studied, no effective prevention or treatment of preeclampsia is yet available for pregnant women. This is surprising considering the growing body of literature that supports the hypothesis of a beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, to find any clinical data among pregnant women with preeclampsia.

The primary objective of the trial is to investigate the acute and chronic effect of consumption of flavanol-rich chocolate on endothelial function in pregnant women at high risk of preeclampsia. This 12-week efficacy study will permit us to verify the sustainability of the effect of daily intake of flavanol-rich chocolate intake.

Study Type

Interventional

Enrollment (Actual)

160

Phase

  • Phase 2

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

  • Canada
    • Quebec
      • Québec, Quebec, Canada, G1V 0A6
        • Laval university, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.

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

18 years to 40 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women between the ages of 18 and 40 years.
  • Presence of uterine diastolic notches measured by uterine artery Doppler between 10 and 14 weeks.

Exclusion Criteria:

  • Hypertension requiring medication.
  • Currently or previously use of medications interfering with glucose or lipids metabolism.
  • Use of supplements or natural health products that interfere with blood pressure.
  • Consumption of 1 or more alcohol drink per day.
  • Allergy or intolerance to nuts or chocolate.

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

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Dark chocolate
Other: Flavanol-rich chocolate
The aim of this study is to evaluate the beneficial effect of dark chocolate consumption through the activity of flavanols on the endothelial function and blood pressure regulation, in acute (after 3 hours) and chronic effect (12 weeks), among pregnant women at high risk for preeclampsia.
PLACEBO_COMPARATOR: Placebo chocolate
Placebo intervention
Other: Placebo Chocolate
Placebo intervention
Other Names:
  • Flavanol and theobromine-free chocolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Changes in endothelial function
Time Frame: within the first 12 weeks of chocolate intake
within the first 12 weeks of chocolate intake

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Doppler of uterine arteries
Time Frame: within the first 12 weeks of chocolate intake
within the first 12 weeks of chocolate intake
Blood pressure
Time Frame: within the first 12 weeks of chocolate intake
within the first 12 weeks of chocolate intake
Plasma biomarker of endothelium function
Time Frame: within the first 12 weeks of chocolate intake
within the first 12 weeks of chocolate intake
Plasma biomarker of chocolate intake
Time Frame: within the first 12 weeks of chocolate intake
ng\ml plasma
within the first 12 weeks of chocolate intake

Collaborators and Investigators

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

Sponsor

Laval University

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

May 1, 2011

Primary Completion (ACTUAL)

September 1, 2014

Study Completion (ACTUAL)

September 1, 2014

Study Registration Dates

First Submitted

May 2, 2011

First Submitted That Met QC Criteria

September 8, 2011

First Posted (ESTIMATE)

September 9, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

April 9, 2015

Last Update Submitted That Met QC Criteria

April 8, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IC096501

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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