Ignite Creation Date:
2025-12-25 @ 4:43 AM
Ignite Modification Date:
2025-12-26 @ 3:44 AM
Study NCT ID:
NCT01706718
Status:
COMPLETED
Last Update Posted:
2012-10-15
First Post:
2012-09-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Beetroot Enriched Bread, Blood Pressure and Vascular Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2014-02-22', 'releaseDate': '2014-01-13'}, {'resetDate': '2014-04-09', 'releaseDate': '2014-03-04'}, {'releaseDate': '2014-07-09', 'unreleaseDateUnknown': True}, {'resetDate': '2014-08-14', 'releaseDate': '2014-07-28'}], 'estimatedResultsFirstSubmitDate': '2014-01-13'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001939', 'term': 'Bread'}], 'ancestors': [{'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-10', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-10-12', 'studyFirstSubmitDate': '2012-09-27', 'studyFirstSubmitQcDate': '2012-10-12', 'lastUpdatePostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-10-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vascular reactivity', 'timeFrame': 'Change from baseline at 2, 4 and 6 hours after bread consumption', 'description': 'Forearm blood flow by Laser Doppler Imaging with iontophoresis'}], 'secondaryOutcomes': [{'measure': 'Arterial stiffness', 'timeFrame': 'Change from baseline at 2, 4 and 6 hours after bread consumption', 'description': 'Pulse wave analysis (PWA) and velocity (PWV)'}, {'measure': 'Blood pressure', 'timeFrame': 'Change from baseline at 30 minute intervals for 7 hours', 'description': 'By ambulatory blood pressure monitor'}, {'measure': 'Plasma nitrate', 'timeFrame': 'Every 30 minutes for 7 hours'}, {'measure': 'Plasma nitrite', 'timeFrame': 'Every 30 minutes for 7 hours'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Beetroot', 'Blood pressure', 'Vascular function'], 'conditions': ['Hypertension']}, 'referencesModule': {'references': [{'pmid': '22414688', 'type': 'BACKGROUND', 'citation': 'Hobbs DA, Kaffa N, George TW, Methven L, Lovegrove JA. Blood pressure-lowering effects of beetroot juice and novel beetroot-enriched bread products in normotensive male subjects. Br J Nutr. 2012 Dec 14;108(11):2066-74. doi: 10.1017/S0007114512000190. Epub 2012 Mar 14.'}, {'pmid': '23884387', 'type': 'DERIVED', 'citation': 'Hobbs DA, Goulding MG, Nguyen A, Malaver T, Walker CF, George TW, Methven L, Lovegrove JA. Acute ingestion of beetroot bread increases endothelium-independent vasodilation and lowers diastolic blood pressure in healthy men: a randomized controlled trial. J Nutr. 2013 Sep;143(9):1399-405. doi: 10.3945/jn.113.175778. Epub 2013 Jul 24.'}]}, 'descriptionModule': {'briefSummary': 'Dietary nitrate is known to lower blood pressure. Beetroot is a rich source of nitrate and could therefore be an important dietary component in the management of hypertension and cardiovascular disease, however consumption is relatively low. We evaluated the effects of beetroot enriched bread ingestion on acute microvascular reactivity, arterial stiffness and blood pressure response in healthy men.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '64 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male\n* A signed consent form\n* Age 18-64 years\n* Body mass index - 18.5-30 kg/m2\n* Non-smoking, healthy individuals\n* Normal blood pressure at screening (\\< 150/90)\n\nExclusion Criteria:\n\n* Subjects with anaemia\n* Sufferers of chronic illnesses\n* Individuals with food allergies\n* People with diabetes\n* People with coeliac disease\n* Women\n* Vegetarians'}, 'identificationModule': {'nctId': 'NCT01706718', 'briefTitle': 'Beetroot Enriched Bread, Blood Pressure and Vascular Function', 'organization': {'class': 'OTHER', 'fullName': 'University of Reading'}, 'officialTitle': 'The Effects of Beetroot Enriched Bread on Postprandial Vascular Function, Arterial Stiffness and Blood Pressure in Healthy Men', 'orgStudyIdInfo': {'id': '10/18'}, 'secondaryIdInfos': [{'id': 'University of Reading', 'type': 'OTHER', 'domain': 'University of Reading'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control white bread', 'interventionNames': ['Dietary Supplement: Bread']}, {'type': 'EXPERIMENTAL', 'label': 'Beetroot bread', 'interventionNames': ['Dietary Supplement: Bread']}], 'interventions': [{'name': 'Bread', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Beetroot bread', 'Control white bread']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'RG6 6AP', 'city': 'Reading', 'state': 'Berkshire', 'country': 'United Kingdom', 'facility': 'University of Reading', 'geoPoint': {'lat': 51.45625, 'lon': -0.97113}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Reading', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Julie Lovegrove', 'investigatorAffiliation': 'University of Reading'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2014-01-13', 'type': 'RELEASE'}, {'date': '2014-02-22', 'type': 'RESET'}, {'date': '2014-03-04', 'type': 'RELEASE'}, {'date': '2014-04-09', 'type': 'RESET'}, {'date': '2014-07-09', 'type': 'RELEASE'}, {'type': 'UNRELEASE', 'dateUnknown': True}, {'date': '2014-07-28', 'type': 'RELEASE'}, {'date': '2014-08-14', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Julie Lovegrove, Professor, University of Reading'}}}}