Ignite Creation Date:
2025-12-25 @ 4:01 AM
Ignite Modification Date:
2026-04-24 @ 11:58 PM
Study NCT ID:
NCT02397902
Status:
COMPLETED
Last Update Posted:
2018-02-01
First Post:
2015-03-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D058246', 'term': 'Prehypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-01', 'completionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-01-30', 'studyFirstSubmitDate': '2015-03-16', 'studyFirstSubmitQcDate': '2015-03-19', 'lastUpdatePostDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-03-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Seated blood pressure', 'timeFrame': '4 weeks'}], 'secondaryOutcomes': [{'measure': '24-hour ambulatory blood pressure', 'timeFrame': '4 weeks'}, {'measure': 'Carotid arterial compliance as measured by arterial pressure and corresponding cross-sectional area by ultrasound', 'timeFrame': '4 weeks'}, {'measure': 'Arterial stiffness as measured by pulse wave velocity between the aortic arch and femoral artery', 'timeFrame': '4 weeks'}, {'measure': 'Flow mediated dilation', 'timeFrame': '4 weeks'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Hypertension', 'Prehypertension']}, 'descriptionModule': {'briefSummary': 'The specific aim of the proposed study is to address the efficacy of conventional full-fat dairy products as part of the normal routine diet for improving vascular function and reducing blood pressure in middle-aged and older adults with elevated blood pressure. The investigators hypothesize that dietary intervention including whole milk and full-fat milk products will induce significant decreases in systolic blood pressure and arterial stiffness. The investigators also test the hypothesis that the reductions in blood pressure will be associated with the corresponding decreases in arterial stiffness and/or increases in endothelial vasodilatory function as well as improvements in arterial baroreflex sensitivity. If our hypotheses are supported by the results, the information could be used as a basis for recommendations for the use of whole milk and full-fat milk products in the secondary prevention of elevated blood pressure and vascular dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Prehypertension or stage-1 hypertension\n\nExclusion Criteria:\n\n* Consume \\> 3 servings of dairy or fruit per day\n* Strenuous physical activity \\> 3 time per week\n* Lactose intolerance, pregnancy, lactation, and/or alcohol abuse\n* Taking cardiovascular-acting drugs\n* Overt cardiovascular disease, metabolic disease, GI disorders and/or renal disease'}, 'identificationModule': {'nctId': 'NCT02397902', 'briefTitle': 'Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas at Austin'}, 'officialTitle': 'Destiffening and Hypotensive Effects of Whole Milk and Full-fat Dairy Products', 'orgStudyIdInfo': {'id': 'UTexasAustin'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dairy', 'description': 'Add 4 daily servings of high fat dairy to diet for a period of 4 weeks', 'interventionNames': ['Dietary Supplement: High fat dairy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Plant-based', 'description': 'Add 4 daily servings of fruit to diet and/or plant-based milk, remove all dairy from diet for a period of 4 weeks', 'interventionNames': ['Dietary Supplement: Plant-based']}], 'interventions': [{'name': 'High fat dairy', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Add 4 daily servings per day of high fat dairy (yogurt, milk, cheese) for a period of 4 weeks', 'armGroupLabels': ['Dairy']}, {'name': 'Plant-based', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Add 4 daily servings of fruit (fruit cup, apple sauce) and/or plant-based milk, remove all dairy for a period for 4 weeks', 'armGroupLabels': ['Plant-based']}]}, 'contactsLocationsModule': {'locations': [{'zip': '78712', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas at Austin', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}], 'overallOfficials': [{'name': 'Tanaka Hirofumi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas at Austin'}, {'name': 'Stephen J Roy, MS', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas at Austin'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas at Austin', 'class': 'OTHER'}, 'collaborators': [{'name': 'Dairy Management Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Stephen J. Roy', 'investigatorAffiliation': 'University of Texas at Austin'}}}}