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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dark chocolate | Experimental |
| |
| Placebo chocolate | Placebo Comparator | Placebo intervention |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol-rich chocolate | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in endothelial function | within the first 12 weeks of chocolate intake |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sylvie Dodin, MD | Laval University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels. | Québec | Quebec | G1V 0A6 | Canada |
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| ID | Term |
|---|---|
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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|
| Placebo Chocolate | Other | Placebo intervention |
|
|
| within the first 12 weeks of chocolate intake |
| Plasma biomarker of chocolate intake | ng\ml plasma | within the first 12 weeks of chocolate intake |