Ignite Creation Date:
2025-12-25 @ 4:13 AM
Ignite Modification Date:
2025-12-26 @ 3:12 AM
Study NCT ID:
NCT04163120
Status:
COMPLETED
Last Update Posted:
2019-11-14
First Post:
2019-11-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of a Ketogenic Diet on PCOS Outcomes
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single arm study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-11-13', 'studyFirstSubmitDate': '2019-11-10', 'studyFirstSubmitQcDate': '2019-11-13', 'lastUpdatePostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Body Weight', 'timeFrame': '12 weeks', 'description': 'Body weight will be measured by an electronic scale'}, {'measure': 'Fat body mass', 'timeFrame': '12 weeks', 'description': 'will be analysed by Dual X Ray Absorptiometry (DEXA) Hologic HorizonTM QDR RSeries Bedford, Massachusetts, USA'}, {'measure': 'LH', 'timeFrame': 'after 12 weeks', 'description': 'LH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'FSH', 'timeFrame': '12 weeks', 'description': 'FSH will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'Total testosterone', 'timeFrame': '12 weeks', 'description': 'Total testosterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'Insulin', 'timeFrame': '12 weeks', 'description': 'Insulin will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'DHEAS', 'timeFrame': '12 weeks', 'description': 'DHEAS will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'progesterone', 'timeFrame': '12 weeks', 'description': 'progesterone will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'estradiol', 'timeFrame': '12 weeks', 'description': 'estradiol will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'SHBG', 'timeFrame': '12 weeks', 'description': 'SHBG will be measured by immunochemiluminescent method (Roche Cobas e601, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'HOMA', 'timeFrame': '12 weeks', 'description': 'HOMA-IR will be calculated according to the formula "insulinemia (μU/mL) x glycemia (mmol/L)/22.5'}, {'measure': 'blood glucose', 'timeFrame': '12 weeks', 'description': 'blood glucose will be measured by enzymatic method with esokinase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'Hirsutism .', 'timeFrame': '12 weeks', 'description': 'we will use Ferriman Gallwey Score. A score of 1 to 4 is given for nine areas of the body. A total score less than 8 is considered normal, a score of 8 to 15 indicates mild hirsutism, and a score greater than 15 indicates moderate or severe hirsutism. A score of 0 indicates absence of terminal hair.'}], 'secondaryOutcomes': [{'measure': 'Ketone bodies', 'timeFrame': '12 weeks', 'description': 'Ketone bodies will be measured by Precision Xtra® Blood β-Ketone Test Strips and Precision Xtra® (28) (Abbott Laboratories, Illinois 60064-3500, USA)'}, {'measure': 'total cholesterol', 'timeFrame': '12 weeks', 'description': 'total cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'HDL cholesterol', 'timeFrame': '12 weeks', 'description': 'HDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'LDL cholesterol', 'timeFrame': '12 weeks', 'description': 'LDL cholesterol will be measured by enzymatic colorimetric in homogenous phase (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)'}, {'measure': 'Triglycerides', 'timeFrame': '12 weeks', 'description': 'TGs by an enzymatic colorimetric method (Roche Cobas e702, Roche Diagnostics, Mannheim, Germany)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome']}, 'referencesModule': {'references': [{'pmid': '22327146', 'type': 'BACKGROUND', 'citation': 'Paoli A, Grimaldi K, Toniolo L, Canato M, Bianco A, Fratter A. Nutrition and acne: therapeutic potential of ketogenic diets. Skin Pharmacol Physiol. 2012;25(3):111-7. doi: 10.1159/000336404. Epub 2012 Feb 11.'}, {'pmid': '23801097', 'type': 'BACKGROUND', 'citation': 'Paoli A, Rubini A, Volek JS, Grimaldi KA. Beyond weight loss: a review of the therapeutic uses of very-low-carbohydrate (ketogenic) diets. Eur J Clin Nutr. 2013 Aug;67(8):789-96. doi: 10.1038/ejcn.2013.116. Epub 2013 Jun 26.'}, {'pmid': '31311141', 'type': 'BACKGROUND', 'citation': 'Paoli A, Mancin L, Bianco A, Thomas E, Mota JF, Piccini F. Ketogenic Diet and Microbiota: Friends or Enemies? Genes (Basel). 2019 Jul 15;10(7):534. doi: 10.3390/genes10070534.'}, {'pmid': '16359551', 'type': 'BACKGROUND', 'citation': 'Mavropoulos JC, Yancy WS, Hepburn J, Westman EC. The effects of a low-carbohydrate, ketogenic diet on the polycystic ovary syndrome: a pilot study. Nutr Metab (Lond). 2005 Dec 16;2:35. doi: 10.1186/1743-7075-2-35.'}, {'pmid': '17509728', 'type': 'BACKGROUND', 'citation': 'Galletly C, Moran L, Noakes M, Clifton P, Tomlinson L, Norman R. Psychological benefits of a high-protein, low-carbohydrate diet in obese women with polycystic ovary syndrome--a pilot study. Appetite. 2007 Nov;49(3):590-3. doi: 10.1016/j.appet.2007.03.222. Epub 2007 Apr 4.'}, {'pmid': '40168063', 'type': 'DERIVED', 'citation': 'Moro T, Monaco L, Naro F, Reggiani C, Paoli A. Exercise Intensity and Rest Intervals Effects on Intracellular Signals and Anabolic Response of Skeletal Muscle to Resistance Training. J Strength Cond Res. 2024 Oct 1;38(10):1695-1703. doi: 10.1519/JSC.0000000000004209. Epub 2022 Jan 5.'}, {'pmid': '32103756', 'type': 'DERIVED', 'citation': 'Paoli A, Mancin L, Giacona MC, Bianco A, Caprio M. Effects of a ketogenic diet in overweight women with polycystic ovary syndrome. J Transl Med. 2020 Feb 27;18(1):104. doi: 10.1186/s12967-020-02277-0.'}]}, 'descriptionModule': {'briefSummary': 'The aim of the study is to investigate the effects of a low calorie Mediterranean ketogenic diet on Polycystic Ovary Syndrome (PCOS) related outcomes.', 'detailedDescription': 'Fourteen overweight women with diagnosis of Polycystic Ovary Syndrome (PCOS) will undergo to a low calorie ketogenic Mediterranean diet with phyoextracts (KEMEPHY) for 12 week. Changes in body weight, body mass index (BMI), fat body mass (FBM), lean body mass (LBM), visceral adipose tissue (VAT), insulin, glucose, HOMA-IR, total cholesterol, low density lipoprotein (LDL), high density lipoprotein (HDL(, triglycerides (TGs), total and free testosterone, luteinizing hormone (LH), follicle stimulating hormone (FSH); dehydroepiandrosterone sulfate (DHEAs), estradiol, progesterone, sex hormone binding globulin (SHBG) and Ferriman Gallwey score will be evaluated.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\ndiagnosis of PCOS according Rotterdam Criteria (at least 2 of 3 between\n\n* oligo/anovulation\n* hyperandrogenism\n* clinical (hirsutism or less commonly male pattern alopecia) or biochemical (raised FAI or free testosterone) polycystic ovaries on ultrasound Other inclusion criteria\n* fertile age (18-45 years);\n* BMI\\> 25 kg/m2,\n* desire to lose weight;\n* acceptance not to use contraceptives during the experimental period\n\nExclusion Criteria:\n\n* pregnancy and lactation,\n* hormonal therapy and/or insulin-sensitizers in the last 2 months,\n* hepatic, renal and heart diseases'}, 'identificationModule': {'nctId': 'NCT04163120', 'briefTitle': 'Effects of a Ketogenic Diet on PCOS Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'University of Padova'}, 'officialTitle': 'Effects of a Low Calorie Mediterranean Ketogenic Diet in Women With Polycystic Ovary Syndrome', 'orgStudyIdInfo': {'id': 'KDPCOS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'In this single arm study subjects follow a low calorie mediterranean ketogenci diet', 'interventionNames': ['Other: Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)']}], 'interventions': [{'name': 'Low calorie Mediterranean ketogenic diet with phytoextracts (KEMEPHY)', 'type': 'OTHER', 'description': 'The KEMEPHY diet (24-29) is a Mediterranean low calories ketogenic protocol (about 1000/1100 Kcal/day) with the use of some phytoextracts. During this protocol subjects are allowed to eat with no limits green leafy vegetables, cruciferous, zucchini, cucumbers and eggplants. The quantity of meat, eggs and fish was limited to once a day (120g of meat or 200g of fish or 1 egg) Table 1. Moreover, subjects daily consumed four food supplements and liquid herbal extracts. Food supplements are high proteins (19g/portion) and very low carbohydrate (3.5g/portion) formulas simulating the aspect and taste of common carbohydrate rich foods added with dry phytoextracts (30). Liquid herbal extracts were used for their draining /toning activity, useful to reduce some commonly reported light side effects of ketogenic diets as constipation, headache and halitosis.', 'armGroupLabels': ['Intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35131', 'city': 'Padua', 'country': 'Italy', 'facility': 'Nutrition and Exercise Lab, DSB, University of Padova', 'geoPoint': {'lat': 45.40797, 'lon': 11.88586}}], 'overallOfficials': [{'name': 'Antonio Paoli, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Padova'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Padova', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Palermo', 'class': 'OTHER'}, {'name': 'Universita di Verona', 'class': 'OTHER'}, {'name': 'Vita-Salute San Raffaele University', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Antonio Paoli', 'investigatorAffiliation': 'University of Padova'}}}}