Consumption of Chocolate in Pregnant Women. (CHOCENTA)
Primary Purpose
Preeclampsia
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Flavanol-rich chocolate
Placebo Chocolate
Sponsored by
About this trial
This is an interventional prevention trial for Preeclampsia focused on measuring Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index
Eligibility 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.
Sites / Locations
- Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Dark chocolate
Placebo chocolate
Arm Description
Placebo intervention
Outcomes
Primary Outcome Measures
Changes in endothelial function
Secondary Outcome Measures
Doppler of uterine arteries
Blood pressure
Plasma biomarker of endothelium function
Plasma biomarker of chocolate intake
ng\ml plasma
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01431443
Brief Title
Consumption of Chocolate in Pregnant Women.
Acronym
CHOCENTA
Official Title
Consumption of Chocolate in Pregnant Women at High Risk for Preeclampsia.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2015
Overall Recruitment Status
Completed
Study Start Date
May 2011 (undefined)
Primary Completion Date
September 2014 (Actual)
Study Completion Date
September 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Laval University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Preeclampsia
Keywords
Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Dark chocolate
Arm Type
Experimental
Arm Title
Placebo chocolate
Arm Type
Placebo Comparator
Arm Description
Placebo intervention
Intervention Type
Other
Intervention Name(s)
Flavanol-rich chocolate
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Placebo Chocolate
Other Intervention Name(s)
Flavanol and theobromine-free chocolate
Intervention Description
Placebo intervention
Primary Outcome Measure Information:
Title
Changes in endothelial function
Time Frame
within the first 12 weeks of chocolate intake
Secondary Outcome Measure Information:
Title
Doppler of uterine arteries
Time Frame
within the first 12 weeks of chocolate intake
Title
Blood pressure
Time Frame
within the first 12 weeks of chocolate intake
Title
Plasma biomarker of endothelium function
Time Frame
within the first 12 weeks of chocolate intake
Title
Plasma biomarker of chocolate intake
Description
ng\ml plasma
Time Frame
within the first 12 weeks of chocolate intake
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sylvie Dodin, MD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.
City
Québec
State/Province
Quebec
ZIP/Postal Code
G1V 0A6
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Consumption of Chocolate in Pregnant Women.
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