Consumption of Chocolate in Pregnant Women. (CHOCENTA)

This study is currently recruiting participants.
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

May 2, 2011
April 18, 2013
May 2011
September 2013   (final data collection date for primary outcome measure)
Changes in endothelial function [ Time Frame: within the first 12 weeks of chocolate intake ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01431443 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Consumption of Chocolate in Pregnant Women.
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.

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.

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Preeclampsia
  • 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
  • Other: Placebo Chocolate
    Placebo intervention
    Other Name: Flavanol and theobromine-free chocolate
  • Experimental: Dark chocolate
    Intervention: Other: Flavanol-rich chocolate
  • Placebo Comparator: Placebo chocolate
    Placebo intervention
    Intervention: Other: Placebo Chocolate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
160
September 2013
September 2013   (final data collection date for primary outcome measure)

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.
Female
18 Years to 40 Years
No
Contact: Claudine Blanchet, PhD 418 656 2336 claudine.blanchet@crsfa.ulaval.ca
Contact: Sylvie Dodin, MD 418 656 2336 sylvie.dodin@ogy.ulaval.ca
Canada
 
NCT01431443
IC096501
Yes
Laval University
Laval University
Not Provided
Principal Investigator: Sylvie Dodin, MD Laval University
Laval University
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP