Ignite Creation Date:
2025-12-24 @ 7:00 PM
Ignite Modification Date:
2025-12-25 @ 4:33 PM
Study NCT ID:
NCT05272657
Status:
UNKNOWN
Last Update Posted:
2022-04-01
First Post:
2022-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Low-Carb Versus Mediterranean Diet in PCOS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'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': 'D050177', 'term': 'Overweight'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050528', 'term': 'Diet, Carbohydrate-Restricted'}, {'id': 'D038441', 'term': 'Diet, Mediterranean'}], 'ancestors': [{'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'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 130}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-03-30', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-03-20', 'studyFirstSubmitDate': '2022-02-28', 'studyFirstSubmitQcDate': '2022-02-28', 'lastUpdatePostDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '1. Homeostasis Model Assessment for Insulin Resistance (HOMA-IR) index', 'timeFrame': '12 weeks', 'description': 'Changes in HOMA-IR index (fasting insulin \\[mU/l\\] \\* fasting glucose \\[mmol/L\\]/22.5) after intervention'}, {'measure': '2. Free androgen index', 'timeFrame': '12 weeks', 'description': 'Changes in free androgen index \\[ (total testosterone level / sex hormone binding globulin (SHBG) level) \\* 100\\].'}], 'secondaryOutcomes': [{'measure': '1. Total testosterone', 'timeFrame': '12 weeks', 'description': 'Changes in total testosterone levels \\[nmol/L\\] in serum after intervention'}, {'measure': '2. Androstenedione', 'timeFrame': '12 weeks', 'description': 'Changes in androstenedione levels in serum after intervention \\[ng/ml\\]'}, {'measure': '3. Anti-Müllerian hormone (AMH)', 'timeFrame': '12 weeks', 'description': 'Changes in AMH levels in serum after intervention \\[ng/ml\\]'}, {'measure': '4. 17-Hydroxyprogesterone (17-OH-progesterone)', 'timeFrame': '12 weeks', 'description': 'Changes in 17-OH-progesterone levels in serum after intervention \\[ng/ml\\]'}, {'measure': '5. Luteinizing hormone (LH)', 'timeFrame': '12 weeks', 'description': 'Changes in LH levels in serum after intervention \\[mU/ml\\]'}, {'measure': '6. Follicle-stimulating hormone (FSH)', 'timeFrame': '12 weeks', 'description': 'Changes in FSH levels in serum after intervention \\[mU/ml\\]'}, {'measure': '7. Insulin', 'timeFrame': '12 weeks', 'description': 'Changes in insulin levels in serum as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 60 min and 120 min) \\[mU/l\\]'}, {'measure': '8. Glucose', 'timeFrame': '12 weeks', 'description': 'Changes in glucose levels in plasma as measured with a two-hour oral glucose tolerance test (75 mg glucose in 300 ml water, blood draws at 0 minutes, 60 min and 120 min) \\[mmol/L\\]'}, {'measure': '9. Matsuda index', 'timeFrame': '12 weeks', 'description': 'Changes in matsuda index after intervention measured with the formula M=10000/squareroot(glucose0 \\* insulin0 \\* Mean OGTT glucose concentration \\* Mean OGTT insulin concentration)'}, {'measure': '10. Hirsutism', 'timeFrame': '12 weeks', 'description': 'measured by Ferriman-Gallwey-score (mFG-score), ranging from 0 to 36, with 0 being the best possible value and 36 the worst'}, {'measure': '11. Body-mass-index (BMI)', 'timeFrame': '12 weeks', 'description': 'BMI measured with the formula BMI=weight \\[kg\\]/height² \\[m\\]'}, {'measure': '12. waist-to-hip ratio', 'timeFrame': '12 weeks', 'description': 'Calculated with the formula: waist circumference/hip circumference'}, {'measure': '13. Gut microbiome composition', 'timeFrame': '12 weeks', 'description': 'Changes in gut microbiome composition measured from stool samples via 16S-RNA gene sequencing'}, {'measure': '14. Inflammatory markers', 'timeFrame': '12 weeks', 'description': 'Changes in inflammatory markers (Cytokines) measured by Human Cytokine/Chemokine/Growth Factor Panel A. 48 plex kit, pg/mL'}, {'measure': '15. Untargeted metabolomics', 'timeFrame': '12 weeks', 'description': 'Serum samples will be analysed to identify biomarkers differentially changing in response to the studied diets using ultra-high performance liquid chromatography (UHPLC).'}, {'measure': '16. Untargeted metabolomics', 'timeFrame': '12 weeks', 'description': 'Serum samples will be analysed to identify biomarkers differentially changing in response to the studied diets using ultra-high performance mass spectrometry (MS).'}, {'measure': '17. Serum Low-density lipoproteins (LDL)', 'timeFrame': '12 weeks', 'description': 'Changes in serum Low-density lipoproteins (LDL), mmol/L'}, {'measure': '18. Serum high-density lipoproteins (LDL)', 'timeFrame': '12 weeks', 'description': 'Changes in serum high-density lipoproteins (LDL), mmol/L'}, {'measure': '19. Serum triglyceride levels, mmol/L', 'timeFrame': '12 weeks', 'description': 'Changes in serum triglyceride levels, mmol/L'}, {'measure': '20. Ovulation rate', 'timeFrame': '12 weeks', 'description': 'Percent of women with ovulation recorded by serial transvaginal ultrasound after 8 weeks of participating in the study'}, {'measure': '21. Ovarian volume', 'timeFrame': '12 weeks', 'description': 'Changes in ovarian volume (cm3) measured by transvaginal ultrasound in early follicular phase or after 3 months of amenorrhea'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['microbiome', 'obesity', 'Mediterranean diet', 'low-carb diet'], 'conditions': ['Polycystic Ovary Syndrome (PCOS)']}, 'descriptionModule': {'briefSummary': 'This is a randomized controlled trial of two diets (low-carbohydrate and Mediterranean diet) in the treatment of women with polycystic ovary syndrome (PCOS). The trial assesses the effects of the two diets on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . This study is an interventional, randomized controlled trial, open-labeled.', 'detailedDescription': 'The study aims to clarify the impact of nutritional recommendations for women with polycystic ovary syndrome on clinical, metabolic and hormonal parameters, inflammatory markers and gut microbiota . Women with PCOS are randomized into 2 treatment groups: one group on a low-carbohydrate diet and the other on a Mediterranean diet. The adhearance to a prescribed diet will be controlled through food intake diaries using a mobile application with electronic reporting forms.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '44 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women with PCOS between the ages of 18-40 years and with a body mass index of less than or equal to 45.\n* Fulfillment of at least two of the following three criteria for PCOS, adopted by the Rotterdam Consensus in 2003 (Rotterdam ESHRE / ASRM-Sponsored PCOS Consensus Workshop Group):\n\n * signs of hyperandrogenemia - clinical and / or biochemical (increase in the index of free androgens or total testosterone)\n * signs of chronic anovulation\n * ultrasound signs: the number of follicles in the ovary ≥ 20 and / or ovarian volume ≥ 10 ml in any ovary in the case of gynecological age 8 or more years after menarche.\n\nExclusion Criteria:\n\n* The presence of hyperprolactinemia\n* Cushing's syndrome\n* Ongenital hyperplasia of the adrenal cortex\n* Hypothyroidism\n* Androgen-producing tumors\n* Regular use of drugs and dietary supplements that affect the function of the ovaries\n* Adrenal glands\n* Metabolism of carbohydrates\n* Lipids\n* Microbiota composition during the 2 months preceding the study\n* Pregnancy\n* Lactation\n* Significant comorbidities"}, 'identificationModule': {'nctId': 'NCT05272657', 'briefTitle': 'Low-Carb Versus Mediterranean Diet in PCOS', 'organization': {'class': 'OTHER', 'fullName': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health'}, 'officialTitle': 'Low-Carbohydrate Diet Versus Mediterranean Diet as Treatment for Women With Polycystic Ovary Syndrome.', 'orgStudyIdInfo': {'id': 'Pcos2typesofDiet'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'low-carbohydrate diet', 'description': 'subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.', 'interventionNames': ['Other: low-carbohydrate diet']}, {'type': 'EXPERIMENTAL', 'label': 'Mediterranean diet', 'description': 'subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.', 'interventionNames': ['Other: Mediterranean diet']}], 'interventions': [{'name': 'low-carbohydrate diet', 'type': 'OTHER', 'description': 'subjects in this arm are given detailed instructions and coaching in following a low-carbohydrate diet.', 'armGroupLabels': ['low-carbohydrate diet']}, {'name': 'Mediterranean diet', 'type': 'OTHER', 'description': 'subjects in this arm are given detailed instructions and coaching in following a Mediterranean diet.', 'armGroupLabels': ['Mediterranean diet']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Polina Popova, MD,PhD', 'role': 'CONTACT', 'email': 'pvpopova@yandex.ru', 'phone': '702-55-95', 'phoneExt': '007(812)'}, {'name': 'Elena Vasiukova', 'role': 'CONTACT', 'email': 'elenavasukova2@gmail.com'}], 'overallOfficials': [{'name': 'Polina Popova, MD,PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Almazov National Medical Research Centre'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Federal State Budgetary Institution, V. A. Almazov Federal North-West Medical Research Centre, of the Ministry of Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}