Ignite Creation Date:
2025-12-24 @ 4:01 PM
Ignite Modification Date:
2025-12-29 @ 12:17 AM
Study NCT ID:
NCT05987566
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2023-07-31
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Chronobiology of Meal Timing: Effects on Vascular and Renal Function
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-15', 'studyFirstSubmitDate': '2023-07-31', 'studyFirstSubmitQcDate': '2023-08-04', 'lastUpdatePostDateStruct': {'date': '2024-03-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Urinary sodium excretion and markers of kidney injury', 'timeFrame': '24 hours', 'description': 'Day and nocturnal urinary sodium, NGAL and KIM-1'}], 'secondaryOutcomes': [{'measure': '24hr ambulatory blood pressure', 'timeFrame': '24 Hours', 'description': 'Day and nocturnal ambulatory blood pressure'}, {'measure': 'Macrovascular function', 'timeFrame': 'At baseline and after each 24hour experimental arm', 'description': 'Brachial artery endothelial function assessed by flow mediated dilation'}, {'measure': 'Microvascular function', 'timeFrame': 'At baseline and after each 24hour experimental arm', 'description': 'Skin blood flow response to local heating measured by laser doppler flowmetry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study us to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function.', 'detailedDescription': "Despite advancements in pharmacologic antihypertensives, hypertension currently affects 1 in 3 Americans and accounts for more than $50 billion of health care spending. Importantly, hypertension is the leading cause of cardiovascular (CVD) and kidney diseases (CKD). As a result, the AHA/ACC lowered the diagnostic criteria for hypertension to encourage earlier preventative lifestyle intervention. There is a critical need to identify and implement novel lifestyle interventions in individuals with early-stage hypertension to prevent the subsequent development of CVD and CKD. Chronotherapy that aligns behavioral cues (such as time of eating) with the body's internal biological clocks, has gained much attention as a potential strategy to prevent and manage hypertension, however, the underlying mechanisms are not yet fully understood. The purpose of this study is to investigate the effects of mistimed eating on blood pressure, kidney function and vascular function."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and Women aged 18-45 years\n* Elevated (SBP 120-129; DBP \\<80 mmHg) or stage 1 hypertension (SBP 130-139; DBP 80-89 mmHg)\n\nExclusion Criteria:\n\n* History of chronic disease (CV, lung, cancer, renal, sleep apnea, diabetes, autoimmune)\n* Anti-hypertensive medication use\n* Currently pregnant or lactating\n* Current shift worker\n* Travel \\>3 time zones four weeks before the start of the study or during the study\n* Insomnia\n* Practiced intermittent fasting in past six months\n* Current nicotine use\n* Current hormone replacement therapy\n* Current melatonin use\n* Current use of antioxidants and unwilling to stop taking them for the duration of the study\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT05987566', 'briefTitle': 'Chronobiology of Meal Timing: Effects on Vascular and Renal Function', 'organization': {'class': 'OTHER', 'fullName': 'Virginia Commonwealth University'}, 'officialTitle': 'Chronobiology of Meal Timing: Effects on Vascular and Renal Function', 'orgStudyIdInfo': {'id': 'HM20026660'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morning Meal Challenge', 'interventionNames': ['Other: Morning meal challenge']}, {'type': 'EXPERIMENTAL', 'label': 'Late Night Meal Challenge', 'interventionNames': ['Other: Evening meal challenge']}], 'interventions': [{'name': 'Morning meal challenge', 'type': 'OTHER', 'description': 'A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten after 1 hour of waking up in the morning', 'armGroupLabels': ['Morning Meal Challenge']}, {'name': 'Evening meal challenge', 'type': 'OTHER', 'description': 'A Western-style diet meal which will be individualized for caloric consumption by estimated total daily energy expenditure eaten within 1 hour of going to bed', 'armGroupLabels': ['Late Night Meal Challenge']}]}, 'contactsLocationsModule': {'locations': [{'zip': '232398', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth Univesity', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}], 'overallOfficials': [{'name': 'Danielle Kirkman', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Virginia Commonwealth University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Virginia Commonwealth University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}