Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2025-12-30 @ 12:07 PM
Study NCT ID:
NCT04580433
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2020-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D009765', 'term': 'Obesity'}], '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': '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-14', 'studyFirstSubmitDate': '2020-09-22', 'studyFirstSubmitQcDate': '2020-10-07', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-10-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Luteinizing hormone (LH) (mIU/mL)', 'timeFrame': '5-week intervention period'}, {'measure': 'Follicle-stimulating hormone (FSH) (mIU/mL)', 'timeFrame': '5-week intervention period'}, {'measure': 'LH/FSH', 'timeFrame': '5-week intervention period'}, {'measure': 'Uric acid (UA) (umol/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Alanine aminotransferase (ALT) (U/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Aspartate aminotransferase (AST) (U/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Total cholesterol (TC) (mmol/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Triglycerides (TG) (mmol/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Low density lipoprotein-cholesterol (LDL-C) (mmol/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Body weight (kg)', 'timeFrame': '5-week intervention period'}], 'primaryOutcomes': [{'measure': 'Insulin resistance', 'timeFrame': '5-week intervention period', 'description': 'Will be assessed by homeostasis model assessment-insulin resistance (HOMA-IR)'}, {'measure': 'Sex hormone-binding globulin (nmol/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Body Mass Index (BMI) (kg/m^2)', 'timeFrame': '5-week intervention period', 'description': 'Weight (kg) and height (m) will be combined to report BMI'}, {'measure': 'Waist-to-Hip Ratio (WHR)', 'timeFrame': '5-week intervention period', 'description': 'Waist and hip will be combined to report WHR'}, {'measure': 'Free androgen index (FAI) (%)', 'timeFrame': '5-week intervention period'}, {'measure': 'Total testosterone (TT) (ng/mL)', 'timeFrame': '5-week intervention period'}, {'measure': 'Area under the curve (AUC) for insulin', 'timeFrame': '5-week intervention period', 'description': 'Insulin release test will be conducted'}, {'measure': 'Area under the curve (AUC) for glucose', 'timeFrame': '5-week intervention period', 'description': 'Glucose tolerance test will be conducted'}, {'measure': 'Area under the curve (AUC) for insulin/Area under the curve (AUC) for glucose', 'timeFrame': '5-week intervention period', 'description': 'Glucose tolerance test will be conducted'}, {'measure': 'Fasting insulin (FINS) (mU/L)', 'timeFrame': '5-week intervention period'}, {'measure': 'Fasting blood glucose (FBG) (mmol/L)', 'timeFrame': '5-week intervention period'}], 'secondaryOutcomes': [{'measure': 'Dietary behavior', 'timeFrame': '5-week intervention period', 'description': 'Measured by the Three Factor Eating Questionnaire Revised 21 Item (TFEQ-R21) questionnaire'}, {'measure': 'Time to return to normal menstrual cycle', 'timeFrame': '5-week intervention period'}, {'measure': 'Insulin-like growth factor 1 (IGF-1) (ng/mL)', 'timeFrame': '5-week intervention period'}, {'measure': 'Body fat (kg)', 'timeFrame': '5-week intervention period', 'description': 'Measured by InBody, a body composition analyzer'}, {'measure': 'Body fat percentage (%)', 'timeFrame': '5-week intervention period', 'description': 'Measured by InBody, a body composition analyzer'}, {'measure': 'Visceral fat area (cm^2)', 'timeFrame': '5-week intervention period', 'description': 'Measured by InBody, a body composition analyzer'}, {'measure': 'Skeletal muscle content (kg)', 'timeFrame': '5-week intervention period', 'description': 'Measured by InBody, a body composition analyzer'}, {'measure': 'High-sensitivity C-reactive protein (hs-CRP) (mg/L)', 'timeFrame': '5-week intervention period', 'description': 'A kind of inflammatory biomarker'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Overweight', 'Obesity']}, 'referencesModule': {'references': [{'pmid': '33849562', 'type': 'DERIVED', 'citation': 'Li C, Xing C, Zhang J, Zhao H, Shi W, He B. Eight-hour time-restricted feeding improves endocrine and metabolic profiles in women with anovulatory polycystic ovary syndrome. J Transl Med. 2021 Apr 13;19(1):148. doi: 10.1186/s12967-021-02817-2.'}]}, 'descriptionModule': {'briefSummary': 'Intermittent fasting is an increasingly popular diet pattern of alternating eating and dieting.One particular form of intermittent fasting is the so-called time-restricted feeding (TRF). TRF allows for ad libitum feeding within a large window of time each day, and does not require any calorie counting. There is growing evidence that it can lose weight, reduce insulin resistance and improve cardiometabolic health. Polycystic ovary syndrome (PCOS) is the most common reproductive endocrine and metabolic disease affecting women of childbearing age. PCOS shows anovulation or oligoovulation, hyperandrogenemia and ovarian polycystic changes. Insulin resistance and obesity are common features of PCOS. Whether the TRF impacts women with PCOS is still unknown due to the paucity of data in this area. To explore the effects of TRF on the endocrine and metabolic profile in overweight women with PCOS, a 6-week single-arm trial, divided into 2 consecutive periods: (1) 1-week baseline period; and (2) 5-week TRF period, will be implemented.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Only women with PCOS.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAge ≥ 18 years; BMI≥24kg/m2; Anovulation; Rott-PCOS.\n\nExclusion Criteria:\n\nTaking weight loss or regulate hormone secretion medications in recent 6 months; The body weight fluctuated more than 5% in the past 3 months; Preparation for pregnancy, having been in pregnancy or lactation; Perimenopausal; Night-shift workers; Fasting more than 16 hours a day; Hypotension; Patients with other diseases (such as congenital adrenal hyperplasia, Cushing syndrome, androgen-secreting tumors, hyperprolactinemia, diabetes, thyroid diseases, severe serious cardiovascular, gastrointestinal, kidney or liver diseases); Alcohol intake more than 100g per week; Smoking within 3 months; Engaging in high-intensity exercise.'}, 'identificationModule': {'nctId': 'NCT04580433', 'acronym': 'PCOS', 'briefTitle': 'Time-restricted Feeding for Treating Polycystic Ovary Syndrome (PCOS)', 'organization': {'class': 'OTHER', 'fullName': 'Shengjing Hospital'}, 'officialTitle': 'Effects of 16:8 Time-restricted Feeding on the Endocrine and Metabolic Profile in Overweight Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': '2020161820'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Time-Restricted Feeding', 'description': 'Participants will receive 16:8 TRF.', 'interventionNames': ['Behavioral: Time-Restricted Feeding']}], 'interventions': [{'name': 'Time-Restricted Feeding', 'type': 'BEHAVIORAL', 'description': 'The trial consists of a 1-week baseline weight stabilization period followed by a 5-week TRF intervention period.\n\nParticipants will be instructed to eat freely from 8 a.m. to 4 p.m. daily and fast from 4 p.m. to 8 a.m. the next day.', 'armGroupLabels': ['Time-Restricted Feeding']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110004', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Shengjing Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}], 'overallOfficials': [{'name': 'Bing He, phD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}, {'name': 'Chunzhu Li, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shengjing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chunzhu Li', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Natural Science Foundation of China', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Clinical Professor', 'investigatorFullName': 'Chunzhu Li', 'investigatorAffiliation': 'Shengjing Hospital'}}}}