Ignite Creation Date:
2025-12-25 @ 2:43 AM
Ignite Modification Date:
2026-02-25 @ 8:26 PM
Study NCT ID:
NCT03696433
Status:
COMPLETED
Last Update Posted:
2025-01-15
First Post:
2018-09-25
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Visualizing Vascular Mechanisms of Salt Sensitivity
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004039', 'term': 'Diet, Sodium-Restricted'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'cassandra.f.reynolds@vumc.org', 'phone': '615-875-9854', 'title': 'Cassandra Reynolds, BS, CCRC', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Baseline up to 8 weeks', 'description': "Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time the consent was signed through participant completion.", 'eventGroups': [{'id': 'EG000', 'title': 'Low Salt Diet', 'description': "Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 1, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'High Salt Diet', 'description': "High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.", 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'episode of syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 19, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Mean Arterial Blood Pressure Following High-salt Diet and Low-salt Diet', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Low Salt Diet', 'description': "Low-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen."}, {'id': 'OG001', 'title': 'High Salt Diet', 'description': "High-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff."}], 'classes': [{'categories': [{'measurements': [{'value': '83.3', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '89.5', 'spread': '9.55', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Following completion of all dietary supplements and washout, in no less than 21 days.', 'description': 'Mean arterial pressure following high-salt diet and low-salt diet', 'unitOfMeasure': 'mmHg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'All Subjects received both a low salt diet and high salt diet. Data reported reflects measure of mean arterial blood pressure following high-salt diet and low-salt diet.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Low- Then High-salt Diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.\n\nLow-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.\n\nHigh-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff."}, {'id': 'FG001', 'title': 'High- Then Low-salt Diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.\n\nLow-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.\n\nHigh-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '9'}, {'groupId': 'FG001', 'numSubjects': '10'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Black men and women 18-55 years old with BMI 25 to \\<35 kg/m2 with BP\\< 140/90 mmHg at screening were recruited as long as they had not used medications for cardiovascular disease, a history of hypertension or diabetes, use of blood pressure or anti-diabetic medications, prevalent renal disease, abnormal serum sodium or potassium. As well as not being a current or prior smoker, pregnant, using hormone replacement therapy, oral contraceptives, or steroids, or had contraindications to MRI.', 'preAssignmentDetails': 'Participants went through a screening process with a physician to determine health and study qualifications. Once screening was complete, participants were assigned to either low-salt or high-salt diet study arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Low- Then High-salt Diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.\n\nLow-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.\n\nHigh-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff."}, {'id': 'BG001', 'title': 'High- Then Low-salt Diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.\n\nLow-salt diet: The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.\n\nHigh-salt diet: The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '25.4', 'groupId': 'BG000', 'lowerLimit': '19', 'upperLimit': '37'}, {'value': '28.1', 'groupId': 'BG001', 'lowerLimit': '20', 'upperLimit': '47'}, {'value': '26.8', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '47'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '9', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Tissue Sodium Content of the Leg', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '6', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.84', 'spread': '1.50', 'groupId': 'BG000'}, {'value': '14.33', 'spread': '3.06', 'groupId': 'BG001'}, {'value': '14.60', 'spread': '2.61', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': 'Measured by standardized sodium 23Na 3.0T MRI in the leg at the widest part of the calf.', 'unitOfMeasure': 'mmol/L', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Tissue sodium content was not obtained in some participants in the low-then-high-salt diet group.'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2020-07-27', 'size': 285489, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-10-31T12:18', 'hasProtocol': True}, {'date': '2023-11-01', 'size': 345431, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-11-04T10:06', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-11-27', 'studyFirstSubmitDate': '2018-09-25', 'resultsFirstSubmitDate': '2023-11-05', 'studyFirstSubmitQcDate': '2018-10-03', 'lastUpdatePostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-11-27', 'studyFirstPostDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-11-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean Arterial Blood Pressure Following High-salt Diet and Low-salt Diet', 'timeFrame': 'Following completion of all dietary supplements and washout, in no less than 21 days.', 'description': 'Mean arterial pressure following high-salt diet and low-salt diet'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['salt sensitive, blood pressure, obesity, magnetic resonance imaging'], 'conditions': ['Obesity', 'Cardiovascular Risk Factor', 'Salt; Excess']}, 'referencesModule': {'references': [{'pmid': '29280322', 'type': 'BACKGROUND', 'citation': 'Crescenzi R, Marton A, Donahue PMC, Mahany HB, Lants SK, Wang P, Beckman JA, Donahue MJ, Titze J. Tissue Sodium Content is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema. Obesity (Silver Spring). 2018 Feb;26(2):310-317. doi: 10.1002/oby.22090. Epub 2017 Dec 27.'}, {'pmid': '28245075', 'type': 'BACKGROUND', 'citation': 'Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.'}]}, 'descriptionModule': {'briefSummary': 'This study aims to assess the salt sensitive blood pressure response to dietary salt load compared with radiological markers of salt handling.', 'detailedDescription': "Hypertension is a major cause of heart disease, heart failure, and stroke. Hypertension, or high blood pressure, affects people differently and is related to the body's ability to maintain healthy circulation of salt. Some individuals may be affected by salt sensitive blood pressure (SSBP), when their blood pressure changes in response to dietary salt load. SSBP is a prevalent, independent risk factor for developing cardiovascular disease that preferentially affects black individuals. Current methods to assess SSBP require dietary salt loading over the course of days to weeks, and measurement of blood pressure following high salt diet and low salt diet. Such lengthy protocols are not feasible in a clinical setting to evaluate this risk factor for cardiovascular disease, and more importantly, these procedures provide incomplete information about mechanisms of salt sensitivity.\n\nOur knowledge regarding salt handling in the body is limited. While renal dysfunction is partly responsible for SSBP, recent research points to the role of lymphatic vascular clearance in regulating tissue salt storage and blood pressure control. To better understand these mechanisms in vivo, we have recently developed a noninvasive magnetic resonance (MR) lymphangiography method sensitive to lymphatic vasculature, and applied standardized MR protocols for measuring tissue sodium and fat storage in adults with impaired lymphatic clearance. We found evidence of lymph stasis and tissue salt deposition that correlated with local subcutaneous fat volume. Here, we will test whether similar lymphatic pathways are impaired in persons with SSBP, leading to tissue salt and fat storage, in comparison to the involvement of renal dysfunction in SSBP tissue profiles.\n\nThe aims of this study are to improve our understanding of vascular mechanisms of human salt storage, and to provide standardized radiologic biomarkers sensitive to the SSBP phenotype. This study will test the primary hypothesis that the SSBP response is correlated with baseline tissue sodium storage, and elevated in persons with salt sensitivity. Secondary hypotheses will address whether the SSBP response is related to fat storage, lymphatic vascular function, renal vascular function, and impaired target organ responses to salt loading, including decreased urinary sodium excretion, and less suppression of plasma renin and serum aldosterone."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Identification as black race\n* Age between 18 and 55 years\n* Body mass index between 25 and \\<35 kg/m2\n* Normotensive or pre-hypertensive\n* Willing to adhere to study diets\n* Able to provide informed consent and communicate with study personnel\n\nExclusion Criteria:\n\n* Prevalent cardiovascular disease or use of medications for cardiovascular disease\n* Current or prior history of hypertension or use of blood pressure lowering medications\n* Current or prior history of diabetes mellitus or use of anti-diabetic medications\n* Prevalent renal disease (eGFR \\< 60 ml/min/1.73m2), abnormal serum sodium or potassium\n* Current or prior smoker\n* Current pregnancy, or use of hormone replacement therapy or oral contraceptive\n* Current steroid use\n* Contraindications to MRI\n* Active infection or open wounds on the top of the feet or hands'}, 'identificationModule': {'nctId': 'NCT03696433', 'briefTitle': 'Visualizing Vascular Mechanisms of Salt Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Visualizing Vascular Mechanisms of Salt Sensitivity', 'orgStudyIdInfo': {'id': '181610'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Low- then high-salt diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.", 'interventionNames': ['Dietary Supplement: Low-salt diet', 'Dietary Supplement: High-salt diet']}, {'type': 'EXPERIMENTAL', 'label': 'High- then low-salt diet', 'description': "10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.", 'interventionNames': ['Dietary Supplement: Low-salt diet', 'Dietary Supplement: High-salt diet']}], 'interventions': [{'name': 'Low-salt diet', 'type': 'DIETARY_SUPPLEMENT', 'description': "The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.", 'armGroupLabels': ['High- then low-salt diet', 'Low- then high-salt diet']}, {'name': 'High-salt diet', 'type': 'DIETARY_SUPPLEMENT', 'description': "The high-salt diet (7 days) consists of each subject's typical diet, supplemented each day with 2 bullion broth packets, which will be provided to the subject by the study staff.", 'armGroupLabels': ['High- then low-salt diet', 'Low- then high-salt diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37212', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Rachelle Crescenzi, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Radiology, Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Instructor', 'investigatorFullName': 'Rachelle Crescenzi', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}