Ignite Creation Date:
2025-12-25 @ 3:23 AM
Ignite Modification Date:
2026-03-04 @ 7:32 AM
Study NCT ID:
NCT02593305
Status:
COMPLETED
Last Update Posted:
2019-10-14
First Post:
2015-10-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Dietary Nitrate and Physiological Aging
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000860', 'term': 'Hypoxia'}], 'ancestors': [{'id': 'D012818', 'term': 'Signs and Symptoms, Respiratory'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'darren-casey@uiowa.edu', 'phone': '3193841009', 'title': 'Dr. Darren P. Casey', 'organization': 'University of Iowa'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'All subjects (young and older) completed the initial study visit. The young adults were used as a comparison group only and did not go through any intervention. The older adults underwent the intervention and completed a total of four study visits.'}}, 'adverseEventsModule': {'timeFrame': 'The length of study enrollment of each older subject (~3 months). Young subjects only completed one single study visit.', 'eventGroups': [{'id': 'EG000', 'title': 'Nitrate', 'description': 'Subjects consumed beet root juice with nitrate for 4 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Placebo', 'description': 'Subjects consumed beet root juice without nitrate (placebo) for 4 weeks.', 'otherNumAtRisk': 13, 'deathsNumAtRisk': 13, 'otherNumAffected': 0, 'seriousNumAtRisk': 13, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Young Comparison Group', 'description': 'Subjects completed one single study visit.', 'otherNumAtRisk': 10, 'deathsNumAtRisk': 10, 'otherNumAffected': 0, 'seriousNumAtRisk': 10, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrate Pre', 'description': 'Subjects randomized to the nitrate group for 4 weeks. Values reflect pre intervention measures.'}, {'id': 'OG001', 'title': 'Nitrate Post', 'description': 'Subjects randomized to the nitrate group for 4 weeks. Values reflect post intervention measures.'}, {'id': 'OG002', 'title': 'Placebo Pre', 'description': 'Subjects randomized to the placebo group for 4 weeks. Values reflect pre intervention measures.'}, {'id': 'OG003', 'title': 'Placebo Post', 'description': 'Subjects randomized to the placebo group for 4 weeks. Values reflect post intervention measures.'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.13', 'spread': '0.04', 'groupId': 'OG000'}, {'value': '-0.05', 'spread': '0.02', 'groupId': 'OG001'}, {'value': '-0.10', 'spread': '0.05', 'groupId': 'OG002'}, {'value': '-0.11', 'spread': '0.05', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.', 'description': 'Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.', 'unitOfMeasure': 'L/min/%SpO2', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}, {'value': '13', 'groupId': 'OG002'}, {'value': '13', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Nitrate Pre', 'description': 'Subjects randomized to the nitrate group for 4 weeks. Values reflect pre intervention measures.'}, {'id': 'OG001', 'title': 'Nitrate Post', 'description': 'Subjects randomized to the nitrate group for 4 weeks. Values reflect post intervention measures.'}, {'id': 'OG002', 'title': 'Placebo Pre', 'description': 'Subjects randomized to the placebo group for 4 weeks. Values reflect pre intervention measures.'}, {'id': 'OG003', 'title': 'Placebo Post', 'description': 'Subjects randomized to the placebo group for 4 weeks. Values reflect post intervention measures.'}], 'classes': [{'categories': [{'measurements': [{'value': '19.2', 'spread': '2.1', 'groupId': 'OG000'}, {'value': '13', 'spread': '2.5', 'groupId': 'OG001'}, {'value': '16.1', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '17', 'spread': '1.9', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.', 'description': 'Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Nitrate First Arm', 'description': 'Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.'}, {'id': 'FG001', 'title': 'Placebo First Arm', 'description': 'Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.'}, {'id': 'FG002', 'title': 'Young Comparison Group', 'description': 'Young subjects only completed a single experimental visit and no intervention. Data from young were used for age-related comparisons at baseline.'}], 'periods': [{'title': 'Baseline 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post 1', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}], 'dropWithdraws': [{'type': 'Comparison only group. No intervention.', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '10'}]}]}, {'title': 'Baseline 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}, {'title': 'Post 2', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Nitrate First Arm', 'description': 'Subjects consumed beet root juice with nitrate for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice without nitrate (placebo) for 4 weeks.'}, {'id': 'BG001', 'title': 'Placebo First Arm', 'description': 'Subjects consumed beet root juice without nitrate (placebo) for 4 weeks during the first arm of the study. After a 4 week washout period, subjects consumed beetroot juice with nitrate for 4 weeks.'}, {'id': 'BG002', 'title': 'Young Comparison Group', 'description': 'Young control group, used for age-related comparisons. This group did not go through any intervention.'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '68', 'spread': '3', 'groupId': 'BG000'}, {'value': '66', 'spread': '2', 'groupId': 'BG001'}, {'value': '67', 'spread': '3', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '25', 'spread': '4', 'groupId': 'BG002'}, {'value': '25', 'spread': '4', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}, {'value': '22', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Body Mass Index', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '26', 'spread': '4', 'groupId': 'BG000'}, {'value': '25', 'spread': '3', 'groupId': 'BG001'}, {'value': '26', 'spread': '3', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '24', 'spread': '3', 'groupId': 'BG002'}, {'value': '24', 'spread': '3', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'kg/m^2', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Systolic Blood Pressure', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '126', 'spread': '12', 'groupId': 'BG000'}, {'value': '118', 'spread': '5', 'groupId': 'BG001'}, {'value': '122', 'spread': '10', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '119', 'spread': '8', 'groupId': 'BG002'}, {'value': '119', 'spread': '8', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Diastolic Blood Pressure', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '76', 'spread': '5', 'groupId': 'BG000'}, {'value': '75', 'spread': '6', 'groupId': 'BG001'}, {'value': '76', 'spread': '5', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '72', 'spread': '5', 'groupId': 'BG002'}, {'value': '72', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mmHg', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Glucose', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '97', 'spread': '7', 'groupId': 'BG000'}, {'value': '96', 'spread': '4', 'groupId': 'BG001'}, {'value': '96', 'spread': '5', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '89', 'spread': '5', 'groupId': 'BG002'}, {'value': '89', 'spread': '5', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Total Cholesterol', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '171', 'spread': '40', 'groupId': 'BG000'}, {'value': '184', 'spread': '31', 'groupId': 'BG001'}, {'value': '177', 'spread': '35', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '153', 'spread': '22', 'groupId': 'BG002'}, {'value': '153', 'spread': '22', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'HDL', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '57', 'spread': '19', 'groupId': 'BG000'}, {'value': '49', 'spread': '21', 'groupId': 'BG001'}, {'value': '53', 'spread': '19', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '60', 'spread': '15', 'groupId': 'BG002'}, {'value': '60', 'spread': '15', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'LDL', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '98', 'spread': '33', 'groupId': 'BG000'}, {'value': '107', 'spread': '33', 'groupId': 'BG001'}, {'value': '102', 'spread': '32', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '82', 'spread': '23', 'groupId': 'BG002'}, {'value': '82', 'spread': '23', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}, {'title': 'Triglycerides', 'classes': [{'title': 'Older Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '7', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '84', 'spread': '39', 'groupId': 'BG000'}, {'value': '144', 'spread': '84', 'groupId': 'BG001'}, {'value': '111', 'spread': '69', 'groupId': 'BG003'}]}]}, {'title': 'Young Adults', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '10', 'groupId': 'BG003'}]}], 'categories': [{'measurements': [{'value': '53', 'spread': '12', 'groupId': 'BG002'}, {'value': '53', 'spread': '12', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'mg/dl', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Row population reflect each distinct age group. Row older adults =13 subjects. Row young adults = 10 subjects. Together the two age groups (rows) total the overall 23 subjects enrolled in the study.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-07-28', 'size': 145444, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2018-10-12T12:39', 'hasProtocol': False}, {'date': '2015-07-01', 'size': 254355, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-07-29T14:00', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-24', 'studyFirstSubmitDate': '2015-10-27', 'resultsFirstSubmitDate': '2018-10-12', 'studyFirstSubmitQcDate': '2015-10-29', 'lastUpdatePostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-09-24', 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-10-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-04-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Carotid Chemosensitivity Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults', 'timeFrame': 'Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.', 'description': 'Carotid chemosensitivity examined by measuring hypoxia ventilatory responsiveness in older adults before and after 4 weeks of beet root juice supplementation and placebo. Chemoreflex sensitivity was quantified as the change in ventilation in relation to the change in pulse oxygen saturation.'}, {'measure': 'Change in Systolic Blood Pressure During Metaboreflex Testing Following 4 Weeks of Dietary Nitrate Supplementation and Placebo in Older Adults.', 'timeFrame': 'Pre and post 4 weeks dietary nitrate supplementation and pre and post 4 weeks of placebo.', 'description': 'Muscle metaboreflex examined by measuring systolic blood pressure responses to ischemic isometric muscle contraction in older adults before and after 4 weeks of beet root juice supplementation and placebo.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['nitrate', 'blood flow', 'blood pressure', 'vascular function', 'hypoxia'], 'conditions': ['Aging']}, 'descriptionModule': {'briefSummary': 'The main purpose/s of this study is to examine the effects of 4 weeks of dietary nitrate supplementation on peripheral chemoreceptor sensitivity, spontaneous baroreflex sensitivity, and blood pressure responsiveness to a variety of physiological stressors in older healthy adults. We will also examine the effect of dietary nitrate supplementation on measures of central artery stiffness and aortic blood pressure in older adults. Lastly, we will also recruit a group of young subjects in order to help characterize the age-related changes associated with the physiological outcome measures of the present study.', 'detailedDescription': '1 in 3 adults in the U.S. have hypertension which is known to increase the risk of heart disease and stroke. Blood pressure regulation is mediated by many factors including but not limited to metabolic factors, pressure/stretch sensing receptors located in the aorta and carotid arteries, endothelial cell function, and kidney function (via water and sodium absorption/excretion). It has been shown that many of these regulatory mechanisms are altered and/or become dysfunctional with aging. Specifically older adults commonly demonstrate a decreased sensitivity in pressure receptors and/or endothelial dysfunction. Additionally with aging, there is an increase in sympathetic nervous system activity and arterial stiffness which can contribute to higher blood pressure. The important vasodilator, nitric oxide (NO), has been implicated as a key signaling molecule involved in several of the mechanisms in blood pressure regulation outlined above. A decreased NO production or bioavailability is thought to contribute to several of the physiologic changes that come with aging. Therefore, the overall aim of this study is to use a randomized, double-blind crossover, placebo controlled study to examine the effects of acute dietary nitrate supplementation (to boost bioavailable NO) on various parameters of blood pressure regulation and responsiveness in normal healthy older adults. Our main hypothesis is that 4 weeks of dietary nitrate supplementation will decrease the blood pressure responses in older adults in response to a variety of physiological stressors.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Two separate age groups were included.\n\nInclusion Criteria:\n\n* Healthy young adults 18-35 years of age (comparison group)\n* Healthy older adults 60-85 years of age (intervention group)\n\nExclusion Criteria:\n\n* Hypertension, hyperlipidemia, current smoker or smoker within the last year, heart disease, diabetes, Chronic obstructive pulmonary disease, asthma, sleep apnea, Raynaud's disease, body mass index (BMI) \\> 30 kg/m2, allergy medication, clinical depression, autonomic disorders and other conditions or medications that might normally alter cardiovascular function, exercise tolerance, and/or blood pressure responses."}, 'identificationModule': {'nctId': 'NCT02593305', 'briefTitle': 'Dietary Nitrate and Physiological Aging', 'organization': {'class': 'OTHER', 'fullName': 'University of Iowa'}, 'officialTitle': 'Dietary Nitrate Supplementation and Physiological Function in Older Adults', 'orgStudyIdInfo': {'id': '201507735'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Beetroot crystals (nitrate), then placebo', 'description': 'Participants will receive a nitrate rich beetroot powder (10g/day) for 4 weeks. After a washout period of 4 weeks, they will then receive the placebo (beetroot powder, no nitrate) for 4 weeks.', 'interventionNames': ['Dietary Supplement: Super Beets', 'Dietary Supplement: Super Beets Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Placebo, then beetroot crystals (nitrate)', 'description': 'Participants will receive a beetroot powder placebo (no nitrate) for 4 weeks. After a 4 week washout period, they will receive the nitrate rich beetroot powder for 4 weeks.', 'interventionNames': ['Dietary Supplement: Super Beets', 'Dietary Supplement: Super Beets Placebo']}, {'type': 'NO_INTERVENTION', 'label': 'Young Comparison', 'description': 'Young control group, used for age-related comparisons. This group did not go through any intervention.'}], 'interventions': [{'name': 'Super Beets', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beetroot crystals'], 'description': 'Nitrate rich beetroot powder (10g/day) for 4 weeks', 'armGroupLabels': ['Beetroot crystals (nitrate), then placebo', 'Placebo, then beetroot crystals (nitrate)']}, {'name': 'Super Beets Placebo', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Beetroot crystals no nitrate'], 'description': 'Nitrate deficient beetroot powder (10g/day) for 4 weeks', 'armGroupLabels': ['Beetroot crystals (nitrate), then placebo', 'Placebo, then beetroot crystals (nitrate)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}], 'overallOfficials': [{'name': 'Darren Casey, PhD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Iowa'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Darren P Casey', 'class': 'OTHER'}, 'collaborators': [{'name': 'Neogenis Laboratories', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Darren P Casey', 'investigatorAffiliation': 'University of Iowa'}}}}