Ignite Creation Date:
2025-12-25 @ 12:39 AM
Ignite Modification Date:
2025-12-25 @ 10:49 PM
Study NCT ID:
NCT05348967
Status:
WITHDRAWN
Last Update Posted:
2025-06-04
First Post:
2022-04-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Combination of D-chiro-inositol With Ketogenic Diet
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'No partecipants enrolled', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2022-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-29', 'studyFirstSubmitDate': '2022-04-22', 'studyFirstSubmitQcDate': '2022-04-22', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HOMA index', 'timeFrame': 'Three time points: change in HOMA index from the baseline to 2 and 4 months', 'description': 'Reduction of HOMA index'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate whether the combination of a product based on D-chiro-inositol and the ketogenic diet can improve the metabolic/endocrine picture of overweight/obese women with PCOS, with insulin resistance, in a shorter time than the ketogenic diet alone', 'detailedDescription': 'Weight loss is the main approach to counteract PCOS phenotype, improving ovulatory function and reducing insulin and systemic levels of free testosterone.\n\nIt is not yet ascertained whether the composition of the diet can have a positive effect on the metabolic pattern; however, it should be considered that blood glucose levels are influenced by the intake of carbohydrates that regulate insulin secretion.\n\nTherefore, low-carbohydrate diets should be preferred over standard low-calorie diets, in terms of improvement in metabolic/endocrine parameters, which accompanies weight loss in women with PCOS.\n\nThe ketogenic diet (KD), a very low-carbohydrate diet capable of developing physiological ketosis, has proven very effective aganist various pathological conditions, including obesity and type 2 diabetes.\n\nIn particular, in the context of KD there is an ever increasing interest in VLCKD (Very Low Calorie Ketogenic Diet) diets with very low calorie content as well as carbohydrates, which have been shown to be effective and safe in the management of metabolic diseases.\n\nEvidence on the efficacy of this diet in PCOS women is still rather scarce. An uncontrolled pilot study, in which VLCKD was followed by 11 overweight/obese women with PCOS for a period of 24 weeks, demonstrated a significant reduction in body weight, free testosterone, LH to FSH ratio and, especially, fasting insulin, suggesting favorable effects in PCOS patients.\n\nIt has been widely demonstrated that the supplementation of inositols, polyols with insulin-sensitizing action, can normalize the metabolic/endocrine picture of PCOS patients, who are overweight/obese and insulin resistant, avoiding the typical gastrointestinal side effects of classic insulin sensitizers.\n\nA recent study on overweight/obese women with PCOS has shown that the association of (low-calorie) diet with inositol supplementation accelerates weight loss, contributing to the restoration of the menstrual cycle.\n\nTherefore, considering the results of this study and bearing in mind the literature that reports that D-chiro-inositol improves glucose tolerance and increases insulin sensitivity in hyperinsulinemic women with polycystic ovary syndrome, we want to investigate whether supplementation with D-chiro-inositol in association with VLCKD can improve the metabolic/endocrine profile of overweight/obese insulin resistant PCOS women in a shorter time than with VLCKD alone.\n\nThis would reduce the period in which patients undergo the VLCKD diet, allowing them to follow a less restrictive and subsequently maintenance diet in the shortest possible time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '25 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women with age between 25 and 40 years\n* Diagnosis of Polycystic Ovary Syndrome (PCOS)\n* Diagnosis of insulin-resistance (HOMA ≥2.5)\n* 26 ≤ BMI ≤32\n\nExclusion Criteria:\n\n* Subjects with no indication for treatment\n* Pregnancy, breastfeeding\n* Treatment with drugs or supplements that interfere with the mechanism of action of insulin'}, 'identificationModule': {'nctId': 'NCT05348967', 'briefTitle': 'Combination of D-chiro-inositol With Ketogenic Diet', 'organization': {'class': 'INDUSTRY', 'fullName': 'Lo.Li.Pharma s.r.l'}, 'officialTitle': 'Association of D-chiro-inositol and the Ketogenic Diet in the Treatment of Overweight/Obese Patients With Insulin Resistance and Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'DCI_KETO22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Ketogenic diet'}, {'type': 'EXPERIMENTAL', 'label': 'TECADRIOL', 'description': 'Ketogenic diet plus a food supplement containing an association of D-chiro-inositol and alpha-lactalbumin', 'interventionNames': ['Dietary Supplement: TECADRIOL']}], 'interventions': [{'name': 'TECADRIOL', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Food supplement with D-chiro-inositol and alpha-lactalbumin', 'armGroupLabels': ['TECADRIOL']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Rome', 'country': 'Italy', 'facility': 'Sapienza University of Rome', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Lo.Li.Pharma s.r.l', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}