Ignite Creation Date:
2025-12-24 @ 2:54 PM
Ignite Modification Date:
2026-01-05 @ 5:55 PM
Study NCT ID:
NCT07250659
Status:
COMPLETED
Last Update Posted:
2025-11-26
First Post:
2025-11-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparing Intermittent Fasting and Mediterranean Diet for Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], 'ancestors': [{'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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2022-06-01', 'size': 485048, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-11-18T09:03', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2022-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-11-18', 'studyFirstSubmitDate': '2025-11-14', 'studyFirstSubmitQcDate': '2025-11-18', 'lastUpdatePostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-12-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Body height (cm)', 'timeFrame': 'Baseline only', 'description': 'Height is measured once at baseline using a wall-mounted stadiometer. Participants stand barefoot, with heels together, arms at the sides, and head positioned in the Frankfurt horizontal plane. The measurement is recorded to the nearest 0.1 centimeter and converted to meters.'}, {'measure': 'Body Fat Percentage', 'timeFrame': 'Baseline and week 4', 'description': 'Body fat percentage is measured at baseline and Week 4 using the TANITA BC-418 body composition analyzer'}, {'measure': 'Fat Free Mass (kg)', 'timeFrame': 'Baseline and Week 4', 'description': 'Fat free mass is assessed using bioelectrical impedance analysis with TANITA BC-418'}, {'measure': 'Total Body Water Percentage', 'timeFrame': 'Baseline and Week 4', 'description': 'Total body water percentage is assessed using bioelectrical impedance analysis with TANITA BC-418.'}, {'measure': 'Waist Circumference (cm)', 'timeFrame': 'Baseline and Week 4', 'description': 'Waist circumference is measured using a non-elastic, flexible measuring tape. The measurement is taken at the midpoint between the lower margin of the last palpable rib and the top of the iliac crest, while the participant stands upright with feet close together and breathes out normally.'}, {'measure': 'Hip Circumference (cm)', 'timeFrame': 'Baseline and Week 4', 'description': 'Hip circumference is measured with using a non-elastic measuring tape. The measurement is taken around the widest portion of the buttocks, with the participant standing upright and feet together.'}], 'primaryOutcomes': [{'measure': 'Body weight (kg)', 'timeFrame': 'Baseline and Week 4', 'description': 'Body weight is measured with using the TANITA BC-418 body composition analyzer. Participants are weighed barefoot, in light clothing, and measurements are recorded in kilograms.'}], 'secondaryOutcomes': [{'measure': 'Body Mass Index (kg/m²)', 'timeFrame': 'Baseline and Week 4', 'description': 'BMI is computed as weight in kilograms divided by height in meters squared (kg/m²)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'intermittent fasting', 'weight loss', 'mediterranean diet'], 'conditions': ['Weight Loss']}, 'descriptionModule': {'briefSummary': 'Purpose: This study aimed to evaluate and compare the effects of intermittent fasting (IF) and the Mediterranean diet (MD) on weight loss in obese adults.\n\nMethods: A total of 120 adults diagnosed with obesity were enrolled. Baseline data on physical activity and dietary intake were collected through structured interviews. Participants were randomly assigned to two groups for a 4-week intervention. The IF group followed a time-restricted eating schedule (16:8), while the MD group followed a structured plan of three main meals and three snacks daily. Both diets included a 500-calorie daily reduction from estimated energy needs. Anthropometric measurements were recorded at baseline and week 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI ≥ 30 kg/m²\n* absence of chronic diseases\n* no regular use of medications\n* non smokers\n* non alcohol users\n* not pregnant or breastfeeding\n* no history of bariatric surgery\n* no significant weight fluctuations (±5 kg) in the past 6 months\n* no pregnancy plans during the study period\n\nExclusion Criteria:\n\n* BMI \\< 30 kg/m²\n* Presence of any diagnosed chronic disease (e.g., diabetes, cardiovascular disease, thyroid disorders, renal or hepatic disease)\n* Regular use of medications that could affect metabolism, appetite, or body weight\n* Smoking or alcohol consumption\n* Pregnancy or breastfeeding during the study period\n* History of bariatric or other weight-related surgical procedures\n* Significant weight changes (gain or loss ≥5 kg) within the past 6 months\n* Planning pregnancy during the study period\n* Inability or unwillingness to comply with dietary intervention and follow-up requirements'}, 'identificationModule': {'nctId': 'NCT07250659', 'briefTitle': 'Comparing Intermittent Fasting and Mediterranean Diet for Obesity', 'organization': {'class': 'OTHER', 'fullName': 'European University of Lefke'}, 'officialTitle': 'Comparative Effects of Intermittent Fasting Versus Mediterranean Diet on Obesity Management: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BAYEK011.02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intermittent fasting diet intervention group', 'description': '4 week time restricted intermittent fasting diet protocol', 'interventionNames': ['Other: Intermittent Fasting Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet intervention group', 'description': '4 week mediterranean diet protocol', 'interventionNames': ['Other: Mediterranean Diet']}], 'interventions': [{'name': 'Intermittent Fasting Diet', 'type': 'OTHER', 'description': 'Participants follow a time-restricted eating pattern for 4 weeks, consuming all meals within an 8-hour eating window (from 1:00 PM to 9:00 PM) and fasting for the remaining 16 hours each day. During the feeding window, they consume two main meals and one snack based on ad libitum intake, without specific calorie restriction. Dietary guidance is provided at the start and mid-point of the protocol by a registered dietitian.', 'armGroupLabels': ['intermittent fasting diet intervention group']}, {'name': 'Mediterranean Diet', 'type': 'OTHER', 'description': 'Participants follow a 4-week Mediterranean diet protocol that is adapted from the PREDIMED criteria and the MedDietScore index. The diet emphasizes high consumption of vegetables, fruits, legumes, whole grains, nuts, and olive oil; moderate intake of fish and poultry; and limited consumption of red meat, dairy products, and sweets. A registered dietitian provides dietary counseling sessions at the beginning and midway through the intervention.', 'armGroupLabels': ['Mediterranean diet intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '99770', 'city': 'Lefka', 'country': 'Cyprus', 'facility': 'European University of Lefke', 'geoPoint': {'lat': 35.11199, 'lon': 32.84997}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kamil Dağcılar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Kamil Dağcılar', 'investigatorAffiliation': 'European University of Lefke'}}}}