Consumption of Chocolate in Pregnant Women. (CHOCENTA)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Laval University
Sponsor:
Information provided by (Responsible Party):
Laval University
ClinicalTrials.gov Identifier:
NCT01431443
First received: May 2, 2011
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention Phase
Preeclampsia
Other: Flavanol-rich chocolate
Other: Placebo Chocolate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.

Resource links provided by NLM:


Further study details as provided by Laval University:

Primary Outcome Measures:
  • Changes in endothelial function [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Doppler of uterine arteries [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]
  • Blood pressure [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]
  • Plasma biomarker of endothelium function [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]
  • Plasma biomarker of chocolate intake [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]
    ng\ml plasma


Estimated Enrollment: 160
Study Start Date: May 2011
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: Flavanol-rich chocolate
Placebo Comparator: Placebo chocolate
Placebo intervention
Other: Placebo Chocolate
Placebo intervention
Other Name: Flavanol and theobromine-free chocolate

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.

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01431443

Contacts
Contact: Claudine Blanchet, PhD 418 656 2336 claudine.blanchet@crsfa.ulaval.ca
Contact: Sylvie Dodin, MD 418 656 2336 sylvie.dodin@ogy.ulaval.ca

Locations
Canada, Quebec
Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels. Recruiting
Québec, Quebec, Canada, G1V 0A6
Contact: Claudine Blanchet, PhD    418 656 2336    claudine.blanchet@crsfa.ulaval.ca   
Contact: Sylvie Dodin, MD    418 656 2336    sylvie.dodin@ogy.ulaval.ca   
Principal Investigator: Sylvie Dodin, MD         
Sponsors and Collaborators
Laval University
Investigators
Principal Investigator: Sylvie Dodin, MD Laval University
  More Information

No publications provided

Responsible Party: Laval University
ClinicalTrials.gov Identifier: NCT01431443     History of Changes
Other Study ID Numbers: IC096501
Study First Received: May 2, 2011
Last Updated: April 18, 2013
Health Authority: Canada: Canadian Institutes of Health Research

Keywords provided by Laval University:
Randomized double blind trial
Cocoa flavonoids
Endothelial function
Blood pressure
Pregnant women
Preeclampsia
Uterine artery flow
Pulsatility index

Additional relevant MeSH terms:
Pre-Eclampsia
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on September 16, 2014