Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2025-12-29 @ 10:41 AM
Study NCT ID:
NCT07219706
Status:
RECRUITING
Last Update Posted:
2025-10-24
First Post:
2025-10-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dietary Fiber and Time Restricted Eating
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'id': 'D001522', 'term': 'Behavior, Animal'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001836', 'term': 'Body Weight Changes'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003376', 'term': 'Counseling'}], 'ancestors': [{'id': 'D008605', 'term': 'Mental Health Services'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}, {'id': 'D003153', 'term': 'Community Health Services'}, {'id': 'D006296', 'term': 'Health Services'}, {'id': 'D005159', 'term': 'Health Care Facilities Workforce and Services'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-22', 'studyFirstSubmitDate': '2025-10-20', 'studyFirstSubmitQcDate': '2025-10-20', 'lastUpdatePostDateStruct': {'date': '2025-10-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dietary fiber intake', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Dietary fiber intake as reported on 3-day diet records and analyzed according to Nutrition Data System for Research; reported as a mean intake over three days in grams per day'}], 'secondaryOutcomes': [{'measure': 'Body mass/weight', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Body mass/weight will be measured in kilograms'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Blood pressure (systolic and diastolic) will be measured at each time frame (in millimeters of mercury \\[mmHg\\])'}, {'measure': 'Blood-based measures of inflammation', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Venous blood samples will be collected and analyzed for inflammatory markers: Granulocyte-macrophage colony-stimulating factor (GM-CSF), interferon-gamma (IFN-γ), interleukin-1 beta (IL-1β), interleukin-2 (IL-2), interleukin-4 (IL-4), interleukin-5 (IL-5), interleukin-6 (IL-6), interleukin-8 (IL-8), interleukin-10 (IL-10), and tumor necrosis factor-alpha (TNF-α).'}, {'measure': 'Blood-based measures of oxidative stress', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Venous blood samples will be collected and analyzed for measures of oxidative stress, including reactive oxygen species and lipid peroxidation'}, {'measure': 'Blood-based measures of insulin resistance', 'timeFrame': 'Baseline, post-intervention (approximately 3 months), and post-observation (approximately 12 months)', 'description': 'Insulin resistance will be measured via assessment of insulin and glucose in venous blood samples, and used to assess Homeostatic Model Assessment of Insulin Resistance (HOMA-IR)'}, {'measure': 'Affect', 'timeFrame': 'Daily for three months', 'description': 'Self-reported affect will be assessed using ecological momentary assessment, delivered via cell phone'}, {'measure': 'Sleep', 'timeFrame': 'Daily for three months', 'description': 'Sleep will be measured via Fitbits, assessed as mean minutes/night'}, {'measure': 'Physical Activity', 'timeFrame': 'Daily for three months', 'description': 'Physical activity will be measured via Fitbits, assessed as mean steps/day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Diet', 'Weight loss', 'Fasting', 'Time restricted eating', 'Time restricted feeding'], 'conditions': ['Diet Habits', 'Cancer Prevention']}, 'descriptionModule': {'briefSummary': 'This study is seeking to examine combinations of two different dietary interventions on cancer risk.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ≥18 age\n* Body mass index ≥30 kg/m2\n* Dietary fiber intake ≤15 g/day\n* Compatible cell phone for use of ecological momentary assessment app\n\nExclusion Criteria:\n\n* Self-reported diagnosis that precludes fiber intake (e.g., inflammatory bowel disease)\n* Food allergies or intolerances that limit ability to engage with the intervention\n* Positive screen on the SCOFF eating disorder screener39\n* Current self-reported use of GLP-1 receptor agonists\n* Currently pregnant or breastfeeding, or planning to become pregnant'}, 'identificationModule': {'nctId': 'NCT07219706', 'acronym': 'FIBER+TRE', 'briefTitle': 'Dietary Fiber and Time Restricted Eating', 'organization': {'class': 'OTHER', 'fullName': 'University of Oklahoma'}, 'officialTitle': 'Examining the Independent and Combined Effects of Dietary Fiber and Time Restricted Eating on Indicators of Cancer Risk: the Fiber and Time Restricted Eating (F.I.T.) Study', 'orgStudyIdInfo': {'id': '18665'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Fiber for Improvement of Behavior, Eating, and Risk (FIBER)', 'interventionNames': ['Behavioral: Group education', 'Behavioral: Counseling']}, {'type': 'EXPERIMENTAL', 'label': 'Time Restricted Eating (TRE)', 'interventionNames': ['Behavioral: Time Restricted Eating']}, {'type': 'EXPERIMENTAL', 'label': 'FIBER and TRE', 'interventionNames': ['Behavioral: Time Restricted Eating', 'Behavioral: Group education', 'Behavioral: Counseling']}], 'interventions': [{'name': 'Time Restricted Eating', 'type': 'BEHAVIORAL', 'description': '10-hour Time Restricted Eating (TRE)', 'armGroupLabels': ['FIBER and TRE', 'Time Restricted Eating (TRE)']}, {'name': 'Group education', 'type': 'BEHAVIORAL', 'description': 'Group education about dietary fiber', 'armGroupLabels': ['FIBER and TRE', 'Fiber for Improvement of Behavior, Eating, and Risk (FIBER)']}, {'name': 'Counseling', 'type': 'BEHAVIORAL', 'description': 'Counseling and motivational interviewing to promote uptake of diet changes', 'armGroupLabels': ['FIBER and TRE', 'Fiber for Improvement of Behavior, Eating, and Risk (FIBER)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '43230', 'city': 'Columbus', 'state': 'Ohio', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Ashlea Braun, PhD', 'role': 'CONTACT', 'email': 'ashlea-braun@ou.edu', 'phone': '567-240-1582'}], 'facility': 'University of Oklahoma Health Sciences', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}], 'centralContacts': [{'name': 'Ashlea Braun, PhD', 'role': 'CONTACT', 'email': 'ashlea-braun@ou.edu', 'phone': '15672401582'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oklahoma', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}