Consumption of Chocolate in Pregnant Women. (CHOCENTA)
This study is currently recruiting participants.
Verified April 2013 by Laval University
Sponsor:
Laval University
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
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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. |
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
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 May 21, 2013