Preeclampsia
Conditions
Keywords
Randomized double blind trial, Cocoa flavonoids, Endothelial function, Blood pressure, Pregnant women, Preeclampsia, Uterine artery flow, Pulsatility index
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.
Interventions
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.
OTHERPlacebo Chocolate
Placebo intervention
Sponsors
Laval University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in endothelial function | within the first 12 weeks of chocolate intake |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Canada
Outcome results
None listed