Ignite Creation Date:
2025-12-25 @ 3:30 AM
Ignite Modification Date:
2026-02-23 @ 11:34 AM
Study NCT ID:
NCT04029805
Status:
UNKNOWN
Last Update Posted:
2020-07-10
First Post:
2019-07-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}, {'id': 'D007333', 'term': 'Insulin Resistance'}], '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': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 34}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-07', 'completionDateStruct': {'date': '2020-08-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-07-09', 'studyFirstSubmitDate': '2019-07-22', 'studyFirstSubmitQcDate': '2019-07-22', 'lastUpdatePostDateStruct': {'date': '2020-07-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-05-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Weight', 'timeFrame': '12 weeks', 'description': 'Weight variation throughout the study'}, {'measure': 'BMI', 'timeFrame': '12 weeks', 'description': 'Body mass index'}, {'measure': 'Blood pressure', 'timeFrame': '12 weeks', 'description': 'Systolic and diastolic pressure during the study'}, {'measure': 'Ovarian cycle', 'timeFrame': '12 weeks', 'description': 'Duration of the ovarian cycle'}], 'primaryOutcomes': [{'measure': 'Plasma insulin', 'timeFrame': '12 weeks', 'description': 'Levels of plasma insulin'}, {'measure': 'Plasma glucose', 'timeFrame': '12 weeks', 'description': 'Levels of plasma glucose'}, {'measure': 'HOMA', 'timeFrame': '12 weeks', 'description': 'Insulin sensitivity'}], 'secondaryOutcomes': [{'measure': 'Total testosterone', 'timeFrame': '12 weeks', 'description': 'Total testosterone'}, {'measure': 'Free testosterone', 'timeFrame': '12 weeks', 'description': 'Free testosterone'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Polycystic ovarian syndrome', 'Extract plant', 'Probiotics', 'Insulin resistance'], 'conditions': ['Polycystic Ovarian Syndrome', 'Insulin Resistance']}, 'descriptionModule': {'briefSummary': 'The aim of the present study is to evaluate the effect of the combination of a plant extract (BSL\\_EP044) and Lactobacillus BSL\\_PS6 on parameters of the glucidic metabolism, anthropometric parameters, hormonal levels and the menstrual cycle in women with polycystic ovary syndrome and high insulin levels.', 'detailedDescription': 'Polycystic ovary syndrome (PCOS) is the most prevalent endocrinopathy in women, affecting 4-15% of those who are of childbearing age. It is a complex and heterogeneous disease in which the gynecological disorder coexist with metabolic problems such as insulin resistance.\n\nThe beneficial effect of the extract plant BSL-EP044 on glycemic metabolism in women with PCOS is widely studied and demonstrated and Lactobacillus BSL\\_PS6 appears to exert a synergistic effect by supplementing the effect of BSL-EP044. The hypothesis of our study is that the addition of the probiotic strain Lactobacillus BSL\\_PS6 to extract plant BSL-EP044 treatment may improve the beneficial effect of this one on insulin resistance and other metabolic alterations related to PCOS.\n\nThe main objective of the present study is to evaluate the effect of the combination of a Plant Extract (BSL\\_EP044) and Lactobacillus BSL\\_PS6 on parameters related to glycemic metabolism in women with polycystic ovary syndrome and high insulin levels.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being diagnosed with polycystic ovarian syndrome according to the Rotterdam criteria.\n* HOMA values between 2.5 and 3.\n* Body mass index of less than 35 kg/m2.\n* Accept freely to participate in the study and sign the informed consent document.\n\nExclusion Criteria:\n\n* Women in treatment with oral antidiabetics.\n* Being pregnant or intending to get pregnant.\n* Be in fertility treatment.\n* To suffer from other diseases that affect the hormonal response or that could interfere with the glucidic metabolism.'}, 'identificationModule': {'nctId': 'NCT04029805', 'briefTitle': 'Evaluation of a Combination of a Plant Extract and a Probiotic on Glucidic Metabolism in Women With PCOS and High Insulin Levels', 'organization': {'class': 'INDUSTRY', 'fullName': 'Biosearch S.A.'}, 'officialTitle': 'Evaluation of the Effect of a Combination of a Plant Extract (BSL_EP044) and Lactobacillus BSL_PS6 on Glucidic Metabolism in Women Suffering From Polycystic Ovary Syndrome and High Insulin Levels', 'orgStudyIdInfo': {'id': 'P044'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Combination of a Plant Extract and a Probiotic', 'description': 'Volunteers will take twice at day for 12 weeks a capsule containing the combination of a plant extract (BSL\\_EP044) and Lactobacillus BSL\\_PS6', 'interventionNames': ['Combination Product: Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Volunteers will take twice at day for 12 weeks a capsule containing maltodextrin.', 'interventionNames': ['Combination Product: Placebo']}], 'interventions': [{'name': 'Combination of a plant extract (BSL_EP044) and Lactobacillus BSL_PS6', 'type': 'COMBINATION_PRODUCT', 'description': 'Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.', 'armGroupLabels': ['Combination of a Plant Extract and a Probiotic']}, {'name': 'Placebo', 'type': 'COMBINATION_PRODUCT', 'description': 'Each participant will consume 2 capsules daily, in the morning and at night without any restriction in the diet nor in their habits of life.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18006', 'city': 'Granada', 'state': 'Andalusia', 'status': 'RECRUITING', 'country': 'Spain', 'facility': 'Clinica Margen', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'centralContacts': [{'name': 'Juristo Fonollá, PhD', 'role': 'CONTACT', 'email': 'Juristo.FonollaJoya@biosearchlife.com', 'phone': '+34958240288'}], 'overallOfficials': [{'name': 'Nicolás Mendoza, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Professor of Gynecology at the Faculty of Medicine of the University of Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Biosearch S.A.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}