Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2026-01-01 @ 7:06 AM
Study NCT ID:
NCT04452968
Status:
COMPLETED
Last Update Posted:
2020-11-25
First Post:
2020-06-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D015431', 'term': 'Weight Loss'}, {'id': 'D000093763', 'term': 'Intermittent Fasting'}], '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'}, {'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': 'D005215', 'term': 'Fasting'}, {'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D031204', 'term': 'Caloric Restriction'}], 'ancestors': [{'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D002149', 'term': 'Energy Intake'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 96}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-11', 'completionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-11-23', 'studyFirstSubmitDate': '2020-06-26', 'studyFirstSubmitQcDate': '2020-06-26', 'lastUpdatePostDateStruct': {'date': '2020-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss in kg', 'timeFrame': 'in 3 months'}], 'secondaryOutcomes': [{'measure': 'decrease in body fat percentage', 'timeFrame': 'in 3 months'}, {'measure': 'fasting plasma insulin', 'timeFrame': 'in 3 months'}, {'measure': 'blood pressure in mm Hg', 'timeFrame': 'in 3 months'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovarian Syndrome', 'Weight Loss', 'Intermittent Fasting']}, 'descriptionModule': {'briefSummary': 'Time restricted feeding (TRF) has been emerging as a potential weight loss strategy that avoids major dietary changes but achieves strong effects. It also improves insulin sensitivity through increased human growth hormone. This effect helps to improve the root cause of weight gain and has additional benefits for women with PCOS.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'females', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* PCOS as described by Rotterdam's criteria\n\nExclusion Criteria:\n\n* endocrine disorders\n* diabetic\n* hypertensive\n* Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;\n* The body weight fluctuated more than 5% in recent 3 months.\n* Liver and kidney dysfunction: renal impairment, creatinine clearance rate \\< 30 mL/min/1.73 m2, transaminase increased, more than three times higher than the normal limit;\n* History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;\n* History of thyroid diseases;\n* pregnant\n* Currently participating in weight loss programs or weight change in the past 3 months (\\> 5% current body weight)\n* Patients who cannot be followed for 16 months (due to a health situation or migration)\n* Patients who are unwilling or unable to give informed consent"}, 'identificationModule': {'nctId': 'NCT04452968', 'briefTitle': 'Comparison of Intermittent Fasting and Caloric Deficit for Weight Loss in Women With Polycystic Ovarian Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Karachi Medical and Dental College'}, 'officialTitle': 'Intermittent Fasting and Polycystic Ovarian Syndrome', 'orgStudyIdInfo': {'id': '33'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'intermittent fasting', 'description': 'Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.\n\nWomen were told about timed restricted feeding. They were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.', 'interventionNames': ['Behavioral: intermittent fasting', 'Behavioral: Caloric restriction']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'caloric restriction', 'description': 'Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.', 'interventionNames': ['Behavioral: Caloric restriction']}], 'interventions': [{'name': 'intermittent fasting', 'type': 'BEHAVIORAL', 'description': 'Women were required to fast for 16 hours and consume their allotted calories during the remaining 8 hours.', 'armGroupLabels': ['intermittent fasting']}, {'name': 'Caloric restriction', 'type': 'BEHAVIORAL', 'description': 'Daily caloric requirement was calculated using basal metabolic rate (BMR) calculator. All women were directed to decrease calorie intake by 500 calories.', 'armGroupLabels': ['caloric restriction', 'intermittent fasting']}]}, 'contactsLocationsModule': {'locations': [{'zip': '74600', 'city': 'Karachi', 'state': 'Sindh', 'country': 'Pakistan', 'facility': 'Aziz Medical Center', 'geoPoint': {'lat': 24.8608, 'lon': 67.0104}}], 'overallOfficials': [{'name': 'Rubina Izhar', 'role': 'STUDY_CHAIR', 'affiliation': 'Aziz Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karachi Medical and Dental College', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aziz Medical Center', 'class': 'NETWORK'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'clinical investigator', 'investigatorFullName': 'samia husain', 'investigatorAffiliation': 'Karachi Medical and Dental College'}}}}