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The purpose of this study is to to test the feasibility of design methods and procedures for later use on a larger scale and to examine the acute and chronic effect of consumption of flavanol-rich chocolate on endothelium function and blood pressure in healthy pregnant women.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dark chocolate | Experimental |
| |
| Placebo chocolate | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavanol-rich dark chocolate | Other | The primary objective of this pilot RCT is to test the feasibility of design methods and procedures for later use on a larger scale. The secondary objective is to examine the acute and chronic effect of dark chocolate on endothelial function and blood pressure, among healthy pregnant women. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in endothelial function and blood pressure | within the first 12 weeks of chocolate intake (week 12 and baseline) |
| Measure | Description | Time Frame |
|---|---|---|
| Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks | within the first 12 weeks of chocolate intake (week 12 and baseline) | |
| Weight change from baseline at 12 weeks | within the first 12 weeks of chocolate intake (week 12 and baseline) |
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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 |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23565841 | Derived | Mogollon JA, Bujold E, Lemieux S, Bourdages M, Blanchet C, Bazinet L, Couillard C, Noel M, Dodin S. Blood pressure and endothelial function in healthy, pregnant women after acute and daily consumption of flavanol-rich chocolate: a pilot, randomized controlled trial. Nutr J. 2013 Apr 8;12:41. doi: 10.1186/1475-2891-12-41. |
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| ID | Term |
|---|---|
| D046110 | Hypertension, Pregnancy-Induced |
| D011225 | Pre-Eclampsia |
| ID | Term |
|---|---|
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D006973 | Hypertension |
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| Placebo Chocolate | Other | Placebo intervention |
|
|
| Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache) | within the first 12 weeks of chocolate intake (week 12 and baseline) |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |