Consumption of Chocolate in Pregnant Women. (CHOCENTA)

Laval University

Status and phase

Completed

Phase 2

Conditions

Preeclampsia

Treatments

Other: Placebo Chocolate

Other: Flavanol-rich chocolate

Study type

Interventional

Funder types

Other

Identifiers

NCT01431443

IC096501

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 patients

Sex

Female

Ages

18 to 40 years old

Volunteers

No Healthy Volunteers

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.