Ignite Creation Date:
2025-12-25 @ 4:30 AM
Ignite Modification Date:
2025-12-26 @ 3:33 AM
Study NCT ID:
NCT07066618
Status:
COMPLETED
Last Update Posted:
2025-07-15
First Post:
2025-06-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Meal Energy Density on Body Measures and Metabolism in Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}], 'ancestors': [{'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-01', 'size': 592464, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-07-04T09:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-03-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-04', 'studyFirstSubmitDate': '2025-06-15', 'studyFirstSubmitQcDate': '2025-07-04', 'lastUpdatePostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in fasting blood glucose', 'timeFrame': 'Baseline to Week 6'}], 'secondaryOutcomes': [{'measure': 'Change in hip circumference', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change in HDL cholesterol', 'timeFrame': 'Baseline to Week 6'}, {'measure': 'Change in HbA1c', 'timeFrame': 'Baseline to Week 6'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['circadian rhythm', 'appetite', 'Meal Timing', 'obesity', 'Glucose Metabolism'], 'conditions': ['Obesity', 'Overweight', 'Appetite Regulation', 'Meal Timing', 'Circadian Rhythm', 'Metabolic Health']}, 'descriptionModule': {'briefSummary': 'This study investigates whether the timing of energy intake during the day-specifically consuming more calories at breakfast or at dinner-affects body measurements, blood sugar levels, cholesterol, and feelings of hunger in women who are overweight or obese.\n\nA total of 28 women participated in the study and were randomly assigned to one of two diet plans: one group consumed half of their daily calories at breakfast, while the other consumed them at dinner. Both groups followed a calorie-restricted diet for six weeks.\n\nThe goal of this research is to understand whether eating more in the morning rather than in the evening leads to better outcomes for weight control and metabolic health. Findings from this study may help health professionals make more effective meal timing recommendations for weight loss and improving blood sugar regulation.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 20-45\n* BMI ≥25 kg/m²\n* Regular menstrual cycle\n* No chronic disease or medication use\n* PSQI ≤5 (Good sleep quality)\n\nExclusion Criteria:\n\n* Pregnancy or lactation\n* Gastrointestinal or metabolic disorders\n* Shift workers, sleep disorders\n* Medication affecting metabolism\n* Weight change \\>4.5 kg in last 6 months'}, 'identificationModule': {'nctId': 'NCT07066618', 'briefTitle': 'Effects of Meal Energy Density on Body Measures and Metabolism in Women', 'organization': {'class': 'OTHER', 'fullName': 'Sakarya Applied Sciences University'}, 'officialTitle': 'Effects of Meal Energy Density on Anthropometric Measurements, Some Metabolic Parameters, And Subjective Appetite in Women', 'orgStudyIdInfo': {'id': 'BASKENT-MEALTIME-2023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Breakfast Group (BG)', 'interventionNames': ['Behavioral: Breakfast-Loaded Hypocaloric Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Dinner Group (DG)', 'interventionNames': ['Behavioral: Dinner-Loaded Hypocaloric Diet']}], 'interventions': [{'name': 'Breakfast-Loaded Hypocaloric Diet', 'type': 'BEHAVIORAL', 'description': "Participants in this group consumed a hypocaloric diet in which 50% of daily energy intake was provided at breakfast, 35% at lunch, and 15% at dinner. Meal times were standardized as follows: breakfast (7:00-9:00), lunch (12:00-14:00), and dinner (18:00-20:00). The diet was individually tailored and provided 20% fewer calories than the participants' total energy expenditure. Macronutrient distribution followed recommended guidelines: 45-60% carbohydrates, 10-20% protein, and 20-35% fat.", 'armGroupLabels': ['Breakfast Group (BG)']}, {'name': 'Dinner-Loaded Hypocaloric Diet', 'type': 'BEHAVIORAL', 'description': "Participants in this group consumed a hypocaloric diet in which 15% of daily energy intake was provided at breakfast, 35% at lunch, and 50% at dinner. Meal times were standardized as follows: breakfast (7:00-9:00), lunch (12:00-14:00), and dinner (18:00-20:00). The diet was individually tailored and provided 20% fewer calories than the participants' total energy expenditure. Macronutrient distribution followed recommended guidelines: 45-60% carbohydrates, 10-20% protein, and 20-35% fat.", 'armGroupLabels': ['Dinner Group (DG)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Sakarya', 'country': 'Turkey (Türkiye)', 'facility': 'Sakarya University of Applied Sciences, Faculty of Sport Sciences, Exercise and Sports Sciences Education, Application and Research Centre', 'geoPoint': {'lat': 39.50333, 'lon': 32.07583}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Melike Nur Eroğlu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Lecturer', 'investigatorFullName': 'Melike Nur Eroğlu', 'investigatorAffiliation': 'Sakarya Applied Sciences University'}}}}