Consumption of Chocolate in Pregnant Women.

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Preeclampsia

Intervention / Treatment
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* Other: Flavanol-rich chocolate
* Other: Placebo Chocolate


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dark chocolate<br> | Other: Flavanol-rich chocolate<br>* 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.<br>|
| Placebo Comparator: Placebo chocolate<br>Placebo intervention | Other: Placebo Chocolate<br>* Placebo intervention<br>* Other names: Flavanol and theobromine-free chocolate;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index