Ignite Creation Date:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-26 @ 3:30 AM
Study NCT ID:
NCT01659060
Status:
COMPLETED
Last Update Posted:
2012-08-07
First Post:
2012-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chocolate Consumption in Healthy Pregnant Women Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D046110', 'term': 'Hypertension, Pregnancy-Induced'}, {'id': 'D011225', 'term': 'Pre-Eclampsia'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 44}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-08', 'completionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-08-02', 'studyFirstSubmitDate': '2012-07-31', 'studyFirstSubmitQcDate': '2012-08-02', 'lastUpdatePostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in endothelial function and blood pressure', 'timeFrame': 'within the first 12 weeks of chocolate intake (week 12 and baseline)'}], 'secondaryOutcomes': [{'measure': 'Changes from baseline in plasma flavanol and methylxanthines(caffeine, theobromine and theophylline) concentrations at 12 weeks', 'timeFrame': 'within the first 12 weeks of chocolate intake (week 12 and baseline)'}, {'measure': 'Weight change from baseline at 12 weeks', 'timeFrame': 'within the first 12 weeks of chocolate intake (week 12 and baseline)'}, {'measure': 'Number of participants with digestive and other signs and symptoms (nausea, abdominal pain, constipation, and headache)', 'timeFrame': 'within the first 12 weeks of chocolate intake (week 12 and baseline)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cacao', 'Chocolate', 'Theobromine', 'Flavonoids', 'Pregnant women', 'Hypertension pregnancy-induced', 'Pre-eclampsia', 'Epicatechin'], 'conditions': ['Hypertension Pregnancy-induced']}, 'referencesModule': {'references': [{'pmid': '23565841', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* non-smoking normotensive women aged from 18 to 35 years, between the 7 and 12 weeks of gestation (documented by ultrasound) and having a live fetus confirmed by fetal heart auscultation\n\nExclusion Criteria:\n\n* Patients with family history of premature cardiovascular disease\n* Chronic hypertension\n* Currently or previously use of medications interfering with glucose or lipids metabolism.\n* Use of supplements or natural health products that interfere with blood pressure.\n* Consumption of 1 or more alcohol drink per day.\n* Allergy or intolerance to nuts or chocolate.'}, 'identificationModule': {'nctId': 'NCT01659060', 'briefTitle': 'Chocolate Consumption in Healthy Pregnant Women Trial', 'organization': {'class': 'OTHER', 'fullName': 'Laval University'}, 'officialTitle': 'Assessment of Blood Pressure and Endothelial Function Pregnancy After Acute and Daily Consumption Flavanol-rich Chocolate Among Healthy Pregnant Women: a Pilot Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '119.05.03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dark chocolate', 'interventionNames': ['Other: Flavanol-rich dark chocolate']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo chocolate', 'interventionNames': ['Other: Placebo Chocolate']}], 'interventions': [{'name': 'Flavanol-rich dark chocolate', 'type': 'OTHER', 'otherNames': ['Chocolate rich in flavanols'], 'description': '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.', 'armGroupLabels': ['Dark chocolate']}, {'name': 'Placebo Chocolate', 'type': 'OTHER', 'otherNames': ['Flavanol-free chocolate'], 'description': 'Placebo intervention', 'armGroupLabels': ['Placebo chocolate']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'G1V 0A6', 'city': 'Québec', 'state': 'Quebec', 'country': 'Canada', 'facility': 'Laval University, Department of Medicine, Institut des nutraceutiques et des aliments fonctionnels', 'geoPoint': {'lat': 46.81228, 'lon': -71.21454}}], 'overallOfficials': [{'name': 'Sylvie Dodin, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Laval University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Laval University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}