Ignite Creation Date:
2025-12-25 @ 3:29 AM
Ignite Modification Date:
2026-01-12 @ 12:53 AM
Study NCT ID:
NCT04503005
Status:
UNKNOWN
Last Update Posted:
2021-04-26
First Post:
2020-07-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000093763', 'term': 'Intermittent Fasting'}, {'id': 'D007249', 'term': 'Inflammation'}], 'ancestors': [{'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-03-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2022-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-22', 'studyFirstSubmitDate': '2020-07-30', 'studyFirstSubmitQcDate': '2020-08-04', 'lastUpdatePostDateStruct': {'date': '2021-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body composition', 'timeFrame': '2 months', 'description': 'change of body fat percentage measured via DEXA'}], 'secondaryOutcomes': [{'measure': 'Blood cholesterol (total, HDL, LDL)', 'timeFrame': '2 months', 'description': 'Change in blood lipid profile'}, {'measure': 'Blood cytokines (IL-6; IL-1, TNF-a)', 'timeFrame': '2 months', 'description': 'Change in blood inflammatory markers'}, {'measure': 'Morningness-Eveningness Questionnaire (MEQ) on chronotype', 'timeFrame': '6 month', 'description': 'effect od diet in eating behaviours. Minimum value is 16, maximum value is 86 Morningness-Eveningness Questionnaire (MEQ) scale is 0-41, evening type; 42-58 Neither-type; 58-68 Morning-type'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['time restricted eating', 'intermitted fasting', 'body composition', 'metabolism', 'inflammation'], 'conditions': ['Healthy Diet', 'Fasting, Intermittent']}, 'referencesModule': {'references': [{'pmid': '39614235', 'type': 'DERIVED', 'citation': 'Sampieri A, Paoli A, Spinello G, Santinello E, Moro T. Impact of daily fasting duration on body composition and cardiometabolic risk factors during a time-restricted eating protocol: a randomized controlled trial. J Transl Med. 2024 Nov 29;22(1):1086. doi: 10.1186/s12967-024-05849-6.'}]}, 'descriptionModule': {'briefSummary': "Over the past century, lifestyles and eating habits have rapidly changed, helping to increase the onset of conditions such as obesity, metabolic syndrome and the risk of cardiovascular and metabolic diseases such as diabetes.\n\nRecently, dietary regimens such as calorie restriction and intermittent fasting have been promoted as new strategies for reducing obesity and related co-morbidities. These strategies have proven effective in reducing body fat, improving blood pressure, lipid profile and insulin resistance in overweight individuals. However, due to the rigidity of these food protocols, the adherence of subjects to the diet is often limited or maintained only for short periods.\n\nTime-Restricted Eating (TRE) is a less extreme form of intermittent fasting, in which the subject's daily calorie intake is consumed only in a certain period of time during the day (normally 8-12 hours). TRE have been able to reduce fat mass, pro-inflammatory markers (eg IL-6, TNF-a) and have improved some biomarkers related to cardiovascular risks (eg Insulin, HDL, TG).\n\nThe literature offers numerous versions of intermittent fasting, and the role of fasting duration is not yet fully clear. Thus. the aim of the present study is to investigate the effect od different duration of fasting in a TRE protocol on body composition and lipid and inflammatory profile. Moreover, the study intended to explore the effect of 2 month of TRE on long term maintenance of diet habits, body composition, lipid and inflammatory profile."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI between 18-30 kg/m2\n* Stable body weight for at least 3 months\n\nExclusion Criteria:\n\n* type 2 Diabetes or pre-diabetes for ADA guidelines\n* Significant Chronic disease\n* recent and acute inflammatory status\n* Recent (within 3 months) treatment with anabolic steroids, systemic corticosteroids or estrogen.\n* regular exercise training (≥ 2 sessions/week) or ≥ 10,000 steps/day'}, 'identificationModule': {'nctId': 'NCT04503005', 'acronym': 'FaTE-TRE', 'briefTitle': 'Fasting Time Effects in Time-Restricted Eating (FaTE-TRE)', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effect of Fasting Duration During a Time-Restricted Eating Diet Protocol', 'orgStudyIdInfo': {'id': 'FaTE-TRE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Effect of fasting duration', 'description': 'study the effect of different daily fasting duration on body composition and blood lipid and inflammatory markers in healthy adults.', 'interventionNames': ['Other: Time Restricted Eating']}, {'type': 'OTHER', 'label': 'Effect of time restricted eating protocol on chronotype', 'description': 'study the effect of 2 month of time restricted eating on the chronotype profile of healthy adults.', 'interventionNames': ['Other: Time Restricted Eating']}], 'interventions': [{'name': 'Time Restricted Eating', 'type': 'OTHER', 'description': 'Effect of 16, 14 or 12 hours of daily fasting', 'armGroupLabels': ['Effect of fasting duration', 'Effect of time restricted eating protocol on chronotype']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35131', 'city': 'Padua', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Tatiana Moro, PhD', 'role': 'CONTACT', 'email': 'tatiana.moro@unipd.it', 'phone': '0498275306'}], 'facility': 'Nutrition and Exercise Lab, DSB, University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'centralContacts': [{'name': 'Tatiana Moro, Ph.D', 'role': 'CONTACT', 'email': 'tatiana.moro@unipd.it', 'phone': '0498275306'}], 'overallOfficials': [{'name': 'Tatiana Moro, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'There is not a plan to make IPD available.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Full Professor', 'investigatorFullName': 'Antonio Paoli', 'investigatorAffiliation': 'University of Padova'}}}}