Ignite Creation Date:
2025-12-26 @ 10:45 PM
Ignite Modification Date:
2025-12-26 @ 10:45 PM
Study NCT ID:
NCT06610812
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2024-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
"KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON POLYCYSTIC OVARIAN ADOLESCENTS"
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled trail'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-07-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-21', 'studyFirstSubmitDate': '2024-09-21', 'studyFirstSubmitQcDate': '2024-09-21', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LH/FSH', 'timeFrame': '3 months', 'description': 'Blood sample was taken from each woman before starting the study to measure the level of androgen in the blood and LH/FSH which will be estimated again after 3months to its level after each type of diet'}, {'measure': 'body mass index', 'timeFrame': '3 months', 'description': 'Weight and height measured while the patient is wearing a thin layer of clothes to calculate the body mass index according to the following equation in both groups: BMI=weight/height2 (Kg/m2)'}], 'secondaryOutcomes': [{'measure': 'waist-hip ratio', 'timeFrame': '3 months', 'description': 'A tape measurement wase used to determine the hip and waist circumference of each patient to calculate the waist-hip ratio by dividing the waist reading over the hip reading (the waist circumference should be measured at the midpoint between the lower margin of the last palpable ribs and the top of the iliac crest , hip circumference obtained by measuring at the top of the iliac crest in case the waist is convex rather than concave, such as with different body types, and obesity, the waist may be measured at a horizontal level (2.5 cm) above the umbilicus .for both measurements.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Disease']}, 'descriptionModule': {'briefSummary': 'study was designed to determine the effect of ketogenic Mediterranean diet versus hypocaloric balanced diet on adolescent female with polycystic ovary disease.', 'detailedDescription': "this study wsa designed to investigate the effect of the ketogenic Mediterranean diet in comparison with hypo-caloric diet on obese adolescent female's patients with polycystic ovary disease trying to find out a new physical therapy approach that had positive effect in the treatment and care for such cases which could enhance the physical therapy field."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '16 Years', 'genderBased': True, 'genderDescription': 'polycystic ovary disease', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1 - All patients were adolescent females. 2- All patients ages ranged from 16 to 21years old. 3- Their BMI ranged from 25kg/m² to 35kg/m². 4- All patients were suffering from hormonal disturbances confirmed by their lab tests and cysts in the ovaries that confirm their diagnosis with polycystic ovary disease.\n\n5- They were conscious and free from any other medical disease.\n\nExclusion Criteria:\n\nPatients were examined by a gynecologist before the study and excluded if they have:\n\n1. Cardiac problems, epileptics and implanted pacemakers.\n2. Pregnancy.\n3. Malignancy and cardiovascular disease.\n4. Women with skin infection.\n5. Dysesthesia.\n6. Cerebrovascular disease.\n7. Uncontrolled diabetes.\n8. Severe uncontrolled cardiac patient.\n9. Liver and kidney dysfunction.'}, 'identificationModule': {'nctId': 'NCT06610812', 'acronym': 'keto- MEDITERR', 'briefTitle': '"KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON POLYCYSTIC OVARIAN ADOLESCENTS"', 'organization': {'class': 'OTHER', 'fullName': 'MTI University'}, 'officialTitle': 'KETOGENIC MEDITERRANEAN VERSUS HYPOCALORIC BALANCED DIET ON Added to Aerobic Exercises POLYCYSTIC OVARIAN ADOLESCENTS', 'orgStudyIdInfo': {'id': 'Cairo university'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'KETOGENIC MEDITERRANEAN diet', 'description': 'It was consist of 20 adolescent females suffering from polycystic ovary disease. they received ketogenic Mediterranean diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.', 'interventionNames': ['Behavioral: KETOGENIC MEDITERRANEAN diet', 'Behavioral: moderate aerobic exercises']}, {'type': 'EXPERIMENTAL', 'label': 'HYPOCALORIC BALANCED DIET', 'description': 'It was consist of 20 adolescent females suffering from polycystic ovary disease. they received hypo-caloric balanced diet program for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.', 'interventionNames': ['Behavioral: hypo-caloric diet:', 'Behavioral: moderate aerobic exercises']}], 'interventions': [{'name': 'KETOGENIC MEDITERRANEAN diet', 'type': 'BEHAVIORAL', 'otherNames': ['KETO- MEDITERRANEAN'], 'description': "each patient in group A was instructed briefly about the nature of the treatment regimen to gain the patient's confidence and cooperation. the patient will receive ketogenic Mediterranean diet with aerobic training program. The diet will contain approximately 9300 kJ accordingly, 37% as total fat, 18% as monounsaturated and 9% as saturated, and 33 g of fiber per day for 3 months with moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.\n\nThis procedure performed by using the components of ketogenic Mediterranean diet:\n\n* Protein source: fatty fish, seafood, poultry, and eggs.\n* Fats and oils: olive oil, avocado oil, and MCT oil (medium-chain triglycerides oil).\n* Low carb vegetables: leafy greens, cruciferous vegetables, and other low carb veggies.\n* Low carb fruits: avocados, olives, and tomato.\n* Flavourings: paprika, cumin, cinnamon, coriander, anise, lemon or lime juice , mint , parsley and garlic .", 'armGroupLabels': ['KETOGENIC MEDITERRANEAN diet']}, {'name': 'hypo-caloric diet:', 'type': 'BEHAVIORAL', 'otherNames': ['hypo-caloric balanced diet:'], 'description': 'Group (b) received low caloric balanced diet regimen with aerobic exercise for 3 months in the form of moderate aerobic exercises in the form of walking for 30 to 45 minutes a day, 3 times per week for 3 months. This group received a diet of 1800 calories or lower accordingly including a combination of two or more of the following in each meal: Non starchy vegetable: spinach, broccoli, cauliflower, peppers, mushrooms, tomatoes, etc.\n\nFruits: berries, apples bears, citrus fruits, melon, grapes bananas, etc. Starchy vegetables: potatoes peas, sweet potatoes etc. Fish and shellfish: salmon, clams, Trouts, oysters, etc. Eggs: whole eggs are more nutrient dense than white eggs. Poultry and meat: chicken turkey, beef, lamb, etc. Whole grains: oats, brown rice, farro etc. Legumes: chickpeas, kidney beans, lentils etc. Healthy fats: avocados, olive oil, unsweetened coconut, avocado oil. Dairy products: full-fat or reduced fat plain yogurt kefir and full-fat cheese.', 'armGroupLabels': ['HYPOCALORIC BALANCED DIET']}, {'name': 'moderate aerobic exercises', 'type': 'BEHAVIORAL', 'otherNames': ['aerobic exercises'], 'description': 'moderate aerobic exercises in the form of walking from 30 to 45 minutes a day, 3 times per week for 3 months.', 'armGroupLabels': ['HYPOCALORIC BALANCED DIET', 'KETOGENIC MEDITERRANEAN diet']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Giza', 'country': 'Egypt', 'facility': 'Cairo Unversity', 'geoPoint': {'lat': 30.00944, 'lon': 31.20861}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'MTI University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Lecturer of physical therapy for women's health in MTIU", 'investigatorFullName': 'shaimaa Mohamed hamed', 'investigatorAffiliation': 'MTI University'}}}}