Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-29 @ 2:32 AM
Study NCT ID:
NCT07181057
Status:
COMPLETED
Last Update Posted:
2025-09-18
First Post:
2025-08-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Neurocognitive Effects of Meal Timing in a One-Meal-a-Day Regimen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-11', 'studyFirstSubmitDate': '2025-08-25', 'studyFirstSubmitQcDate': '2025-09-11', 'lastUpdatePostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-09-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Positive Peak Amplitude of Event-Related Potentials During Stroop - Congruent Trials', 'timeFrame': 'Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.', 'description': 'Maximum voltage deflection (µV) within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes, recorded during congruent Stroop trials using a 32-channel EEG system.'}, {'measure': 'Latency of Positive Peak of Event-Related Potentials During Stroop - Congruent Trials', 'timeFrame': 'Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.', 'description': 'Time point (ms) of maximum positive deflection within 250-450 ms after stimulus onset at CP1, CP2, Pz, P3, O1, and O2 electrodes.'}], 'secondaryOutcomes': [{'measure': 'Resting-State EEG Absolute Power (Eyes-Open and Eyes-Closed)', 'timeFrame': 'Day 1 Morning session (09:30-11:00, pre-meal) and Day 1 Afternoon session (14:30-16:00, ~6 hours post-meal). Each participant completes three separate test days (morning, midday, evening feeding), ≥48 hours apart.', 'description': 'Broadband spectral power (µV²) recorded at CP1, CP2, Pz, P3, O1, and O2 electrodes during standardized eyes-open and eyes-closed resting-state EEG.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fasting State', 'Cognitive Abilities']}, 'descriptionModule': {'briefSummary': 'Objectives: The purpose of this study is to examine how meal timing in a one-meal-a-day (OMAD) regimen influences neurocognitive outcomes.\n\nMethods: Twelve cognitively active participants (academics, students, software engineers) will complete three randomized OMAD conditions, consuming a standardized isocaloric meal at 08:00, 12:30, or 18:00. ERPs will be recorded during a computerized Stroop task to evaluate peak amplitudes and latencies under congruent and incongruent conditions. Resting-state EEG will be measured under eyes-open and eyes-closed conditions. Behavioral performance on the Stroop task, including reaction time and accuracy, will also be assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'To minimize hormone-related variability in electroencephalography and event-related potential measures in this pilot crossover study, enrollment is limited to males.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nMale, 20 to 45 years of age\n\nRight-handed\n\nNormal or corrected-to-normal vision\n\nCognitively active individuals (academic staff, graduate students, or software/algorithm engineers)\n\nRegular sleep-wake schedule during the week preceding the experiment\n\nAbility to abstain from caffeine, alcohol, or psychoactive substances for at least 24 hours prior to each test session\n\nBody mass index between 18.5 and 30 kg/m²\n\nExclusion Criteria:\n\nHistory of neurological, psychiatric, metabolic, or sleep disorders\n\nCurrent use of medications that affect the central nervous system\n\nShift work or irregular sleep patterns (verified by sleep diary)\n\nPrior experience with one-meal-a-day dietary routines\n\nBody mass index below 18.5 or above 30 kg/m²'}, 'identificationModule': {'nctId': 'NCT07181057', 'acronym': 'OMAD', 'briefTitle': 'Neurocognitive Effects of Meal Timing in a One-Meal-a-Day Regimen', 'organization': {'class': 'OTHER', 'fullName': 'Erzurum Technical University'}, 'officialTitle': 'Synergistic Effects of Green Tea Extract and Ginger Supplementation on Endurance Performance and Thermal Perception in Normal and Cold Environments: A Randomized, Double-Blind, Placebo-Controlled, Crossover Study', 'orgStudyIdInfo': {'id': 'ETU-OMAD-2025-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Single Group (Crossover)', 'description': 'Arm Title: Morning Meal (08:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 08:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions.\n\nArm Title: Midday Meal (12:30) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 12:30. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before meal) and afternoon (approximately 6 hours post-meal) sessions.\n\nArm Title: Evening Meal (18:00) Arm Type: Experimental Intervention: Other: One-meal-a-day (OMAD) Arm Description: Participants consume a single standardized isocaloric meal at 18:00. Neurocognitive outcomes (ERP, resting-state EEG, Stroop performance) are assessed during morning (before mea', 'interventionNames': ['Other: one-meal-a-day (OMAD)']}], 'interventions': [{'name': 'one-meal-a-day (OMAD)', 'type': 'OTHER', 'description': 'Arm Title: Morning Meal (08:00)\n\nIntervention: Other: One-meal-a-day (OMAD)\n\nDescription: Participants consume a single isocaloric meal at 08:00.\n\nArm Title: Midday Meal (12:30)\n\nIntervention: Other: One-meal-a-day (OMAD)\n\nDescription: Participants consume a single isocaloric meal at 12:30.\n\nArm Title: Evening Meal (18:00)\n\nIntervention: Other: One-meal-a-day (OMAD)\n\nDescription: Participants consume a single isocaloric meal at 18:00.', 'armGroupLabels': ['Single Group (Crossover)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '25240', 'city': 'Erzurum', 'state': 'Erzurum', 'country': 'Turkey (Türkiye)', 'facility': 'Erzurum Technical University Sport Sciences Faculty', 'geoPoint': {'lat': 39.90861, 'lon': 41.27694}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Erzurum Technical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Exercise Physiology', 'investigatorFullName': 'Süleyman Ulupınar', 'investigatorAffiliation': 'Erzurum Technical University'}}}}