Consumption of Chocolate in Pregnant Women.

Phase 2

Completed

• Conditions: Preeclampsia
• Interventions: Other: Placebo Chocolate; Other: Flavanol-rich chocolate

• Registration Number: NCT01431443
• Lead Sponsor: Laval University

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.

Study Timeline

• Study Start: 2011-05
• Study First Submitted: 2011-05-02
• Study First Submitted QC: 2011-09-08
• Study First Posted: 2011-09-09
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-08
• Last Update Posted: 2015-04-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo chocolate	Placebo Chocolate	Placebo intervention
Dark chocolate	Flavanol-rich chocolate	-

Primary Outcome Measures

Name	Time	Method
Changes in endothelial function	within the first 12 weeks of chocolate intake

Secondary Outcome Measures

Name	Time	Method
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	within the first 12 weeks of chocolate intake	ng\\ml plasma

Trial Locations

Locations (1)

Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels.; 🇨🇦 Québec, Quebec, Canada