Ignite Creation Date:
2025-12-25 @ 3:11 AM
Ignite Modification Date:
2025-12-26 @ 1:50 AM
Study NCT ID:
NCT07135505
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-22
First Post:
2025-08-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Time-Restricted Eating in Older Adults With Hypertension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D005247', 'term': 'Feeding Behavior'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-16', 'studyFirstSubmitDate': '2025-08-14', 'studyFirstSubmitQcDate': '2025-08-14', 'lastUpdatePostDateStruct': {'date': '2025-12-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Baseline and 12 weeks', 'description': 'measured by the continuous glucose monitor'}, {'measure': 'Heart rate variability', 'timeFrame': 'Baseline and 12 weeks', 'description': 'measured by the Holter monitor'}, {'measure': 'Systolic Blood pressure', 'timeFrame': 'Baseline and 12 weeks', 'description': 'measured by the ambulatory blood pressure monitor'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension', 'Eating Behaviors']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to find out how early time-restricted eating affects body rhythms and improves cardiometabolic health in older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Consent to participate in the study\n* Men and women ≥ 60 years old\n* Average office systolic BP ≥130 mmHg\n* Self-reported ≥12 hours eating period per day of at least 5 days/week\n* Stable health history over the past 2 months\n\nExclusion Criteria:\n\n* Fasting \\>12 hours per day\n* Actively trying to lose weight by participating in formal weight loss program or significantly restricting calorie intake\n* Have lost ≥ 10 pounds in last 3 months\n* Unable to wake up at a regular time between 6-8 am\n* Perform overnight shift work more than 1day/week on average\n* Resting heart rate of \\>120 beats per minute, systolic blood pressure \\> 180 mmHg and/or diastolic blood pressure of \\> 100 mmHg\n* Have been diagnosed with diabetes\n* On insulin or diabetes medication\n* Unstable angina, heart attack or stroke in the past 3 months\n* Continuous use of supplemental oxygen to manage a chronic pulmonary condition or heart failure\n* Pregnant or breastfeeding\n* Rheumatoid arthritis, Parkinson's disease or currently on dialysis\n* Current diagnosis of a major psychiatric condition that would impair study participation\n* Severe gastrointestinal disease, major gastrointestinal surgery, or active gallstone disease\n* Active treatment for cancer in the past year\n* Taking medications that preclude fasting for 16 hours (e.g. must be taken with food at least 12 hours apart)"}, 'identificationModule': {'nctId': 'NCT07135505', 'briefTitle': 'Early Time-Restricted Eating in Older Adults With Hypertension', 'organization': {'class': 'OTHER', 'fullName': 'University of Alabama at Birmingham'}, 'officialTitle': 'The Effect of Early Time-Restricted Eating on Cardiometabolic Health and Circadian Rhythms in Hypertensive Older Adults With Habitual Prolonged Eating Window', 'orgStudyIdInfo': {'id': 'IRB-300013053'}, 'secondaryIdInfos': [{'id': 'UAB NORC Pilot Grant', 'type': 'OTHER_GRANT', 'domain': 'UAB Nutrition Obesity Research Center Pilot/Feasibility Grant Program'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention', 'description': 'Early time-restricted eating', 'interventionNames': ['Behavioral: Early time-restricted eating']}, {'type': 'NO_INTERVENTION', 'label': 'Control'}], 'interventions': [{'name': 'Early time-restricted eating', 'type': 'BEHAVIORAL', 'description': 'The participants will be asked to fast for a target of 16 hours per day (eat ad libitum within the 8-hour eating window, starting between 6:30-8:30 am), 6 days/week for 12 weeks. Participants will be allowed to consume calorie-free beverages, sugar-free gum, and will be encouraged to drink plenty of water throughout the entire intervention period.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35294', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'contacts': [{'name': 'Yi Lin, PhD', 'role': 'CONTACT', 'email': 'yilin@uabmc.edu', 'phone': '205-996-5876'}, {'name': 'Yi Lin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Alabama at Birmingham', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'IPD may not be shared due to concerns regarding participant privacy and the sensitive nature of the health-related data collected.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Alabama at Birmingham', 'class': 'OTHER'}, 'collaborators': [{'name': 'UAB Nutrition Obesity Research Center', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Instructor', 'investigatorFullName': 'Yi Lin', 'investigatorAffiliation': 'University of Alabama at Birmingham'}}}}