Ignite Creation Date:
2025-12-24 @ 5:59 PM
Ignite Modification Date:
2026-01-05 @ 6:03 PM
Study NCT ID:
NCT05756868
Status:
COMPLETED
Last Update Posted:
2023-03-06
First Post:
2022-11-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005215', 'term': 'Fasting'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2022-06-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-03-04', 'studyFirstSubmitDate': '2022-11-25', 'studyFirstSubmitQcDate': '2023-03-04', 'lastUpdatePostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-10-24', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '6 week', 'description': 'Body Weight'}, {'measure': 'Body Composition', 'timeFrame': '6 week', 'description': 'total body fluid'}, {'measure': 'Body Composition', 'timeFrame': '6 week', 'description': 'total fat mass'}, {'measure': 'Body Composition', 'timeFrame': '6 week', 'description': 'muscle mass'}, {'measure': 'Body Composition', 'timeFrame': '6 week', 'description': 'fat free mass'}, {'measure': 'Plasma lipids', 'timeFrame': '6 week', 'description': 'Total cholesterol'}, {'measure': 'Plasma lipids', 'timeFrame': '6 week', 'description': 'Hdl cholesterol'}, {'measure': 'Plasma lipids', 'timeFrame': '6 week', 'description': 'Ldl cholesterol'}, {'measure': 'Plasma lipids', 'timeFrame': '6 week', 'description': 'Triglyceride'}, {'measure': 'Blood Pressure', 'timeFrame': '6 week', 'description': 'Systolic blood pressure'}, {'measure': 'Blood Pressure', 'timeFrame': '6 week', 'description': 'Diastolic blood pressure'}, {'measure': 'Pulse', 'timeFrame': '6 week'}, {'measure': 'Biochemistry', 'timeFrame': '6 week', 'description': 'blood glucose'}, {'measure': 'Biochemistry', 'timeFrame': '6 week', 'description': 'fasting insulin'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Fasting']}, 'descriptionModule': {'briefSummary': 'The goal of this randomized controlled trial is to to determine the effects of time-restricted feeding intervention on body weight, body composition, biochemical parameters and eating behaviors in overweight female individuals.\n\nThe main questions it aims to answer are:\n\n1. Does time-restricted feeding intervention reduce daily energy intake?\n2. Does time-restricted dietary intervention result in body weight and body fat loss?\n3. Does time-limited nutritional intervention lead to improvements in biochemical parameters?\n4. Does time-restricted feeding intervention improve eating behavior and eating awareness?\n5. Does time-restricted feeding intervention adversely affect diet quality?\n\nThe participants in the intervention group will receive a time restricted feeding intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants are planned as 8 hours of eating and 16 hours of fasting.\n\nParticipants in the control group will not receive any dietary intervention.', 'detailedDescription': 'Following the ethics committee approval, the study will be carried out with the participants who applied to the Famagusta State Hospital Internal Medicine Polyclinic, Specialist Umut Hakligil.\n\nIn order to start the study, TR Ministry of Health Nicosia Dr. Necessary permissions were obtained from the Ethics Committee of Burhan Nalbantoğlu State Hospital.\n\nThe study is planned to be conducted with 40 female participants, who were not diagnosed with any disease by the physician, aged 19-65, slightly obese, with a BMI of 24.9-29.9 kg/m².\n\nBefore being included in the research, participants will be informed about the purpose of the research and the applications to be made during the research.\n\nThis information was supported with the valid consent form.\n\nData Collection Tool: A questionnaire form developed in line with the research purpose was used as a data collection tool in the research.\n\nWhile collecting data on the individuals participating in the research, the "face-to-face interview method" (mask and distance due to the covid-19 pandemic) by taking necessary precautions such as rules of thumb) will be applied.\n\nBeginning of the Study:\n\nParticipants who meet the study criteria and agree to participate in the study will be randomly assigned to the control group or intervention group.\n\n1. Control group protocol; participants randomized to the control group will not receive any dietary intervention. In this process, how all participants should be asked before starting the study.\n\n If they are fed, they will be asked to continue in the same way and to maintain their physical activity level.\n2. Intervention group protocol; participants randomized to the intervention group will receive a time-restricted feeding intervention for 6 weeks without energy restriction (adlibitum). Meals of the participants will be planned as 8 hours of eating and 16 hours of fasting.\n\nMeal timing will be set as follows:\n\n* First meal at 10:00,\n* Last meal at 18:00 in the evening\n\nParticipants will be asked not to consume anything other than non-calorie drinks (water, only soda, unsweetened herbal teas, etc.) between 18:00 in the evening and 10:00 in the morning.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 19-65 age range\n2. Female\n3. BMI: 24.9-29.9 kg/m²\n4. Maintaining general activity and exercise habits during the study period\n5. Stable body weight (\\<4 kg weight loss or weight gain) for 6 months prior to the start of the study\n\nExclusion Criteria:\n\n1. Those with chronic disease (diabetes, hypertension, cardiovascular disease, etc.)\n2. Drug users\n3. Use of supplements that may affect blood lipid profile and blood sugar (omega-3 etc.)\n4. Pregnant women\n5. People in the lactation period\n6. Menopause\n7. Shift workers\n8. Those who follow a Time Restricted (16:8) nutrition program before the study\n9. Those who have followed any particular diet before the study\n10. Those who frequently apply different weight loss diet programs'}, 'identificationModule': {'nctId': 'NCT05756868', 'briefTitle': 'The Effect of Time-Restricted Feeding on Anthropometry, Biochemical Parameters, Diet Quality and Eating Behavior', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Mediterranean University'}, 'officialTitle': 'The Effect of Time-Restricted Feeding Intervention on Anthropometric Measurements, Biochemical Parameters, Diet Quality and Eating Behavior in Overweight Female Individuals', 'orgStudyIdInfo': {'id': 'AYildirim'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time restricted feeding', 'description': 'The participants in the intervention group will receive a time restricted feeding intervention (first meal at 10:00, last meal at 18:00) for 6 weeks. Meals of the participants are planned as 8 hours of eating and 16 hours of fasting.', 'interventionNames': ['Behavioral: Time restricted feeding']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Participants in the control group will not receive any dietary intervention. All participants were asked to continue in the same way they were fed before starting the study throughout the study.'}], 'interventions': [{'name': 'Time restricted feeding', 'type': 'BEHAVIORAL', 'description': 'In the time-restricted nutrition intervention, the first meal is scheduled at 10:00 and the last meal at 18:00 (ad libitum). Eating for 8 hours and fasting for 16 hours are targeted.', 'armGroupLabels': ['Time restricted feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99628', 'city': 'Famagusta', 'country': 'Cyprus', 'facility': 'Eastern Mediterranean University', 'geoPoint': {'lat': 35.12489, 'lon': 33.94135}}], 'overallOfficials': [{'name': 'AYŞEN YILDIRIM KIZILDAĞ, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Mediterranean University'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': '1 year', 'ipdSharing': 'YES', 'description': 'Study Protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)', 'accessCriteria': 'No individual participant data will be shared. Results will be published by the investigators in academic journals.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Mediterranean University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dietitian (MSc)', 'investigatorFullName': 'Ayşen Yıldırım', 'investigatorAffiliation': 'Eastern Mediterranean University'}}}}