[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100558451":3},{"organization":4,"armGroups":7,"interventions":24,"overallOfficials":23,"centralContacts":23,"locations":30,"responsibleParty":58,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":23,"studyType":76,"phases":77,"briefSummary":79,"conditions":80,"keywords":83,"overallStatus":33,"whyStopped":23,"lastUpdateSubmitDate":88,"lastUpdatePostDateStruct":89,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},{"fullName":5,"class":6},"Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana","OTHER",[8,14,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Dietary supplement in PCOS","ACTIVE_COMPARATOR","Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing inositol, vitamin D, zinc, and curcumin for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).",[13],"Dietary Supplement: Ovapro (Lifepro)",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo in PCOS","PLACEBO_COMPARATOR","Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing yellow colorant for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).",[13],{"label":20,"type":21,"description":22,"interventionNames":23},"No intervention in healthy subjects","NO_INTERVENTION","Healthy subjects will not recieve supplement\u002Fplacebo nor dietary intervention.",null,[25],{"type":26,"name":27,"description":28,"armGroupLabels":29,"otherNames":23},"DIETARY_SUPPLEMENT","Ovapro (Lifepro)","Dietary supplement that contains inositol, vitamin D, zinc, and curcumin.",[9,15],[31],{"facility":32,"status":33,"city":34,"state":34,"zip":35,"country":36,"countryCode":37,"cosmosGeoPoint":38,"geoPoint":43,"contacts":44},"FISABIO","RECRUITING","Valencia","46020","Spain","ES",{"type":39,"coordinates":40},"Point",[41,42],-0.37966,39.47391,{"lat":42,"lon":41},[45,50,53,56],{"name":46,"role":47,"phone":48,"phoneExt":23,"email":49},"Celia Bañuls, PhD","CONTACT","963188882","c.banuls@fisabio.es",{"name":51,"role":52,"phone":23,"phoneExt":23,"email":23},"María Jesús Sanz Llorens, Msc","SUB_INVESTIGATOR",{"name":54,"role":55,"phone":23,"phoneExt":23,"email":23},"Susana Rovira Llopis, PhD","PRINCIPAL_INVESTIGATOR",{"name":57,"role":55,"phone":23,"phoneExt":23,"email":23},"Celia Bañuls Morant, PhD",{"type":59,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"SPONSOR_INVESTIGATOR","Celia Bañuls","Principal Investigator","100558451","study-of-the-effect-of-a-nutritional-supplement-on-microbiota-metabolic-control-inflammatory-profile-and-quality-of-life-in-patients-with-polycystic-ovary-syndrome-100558451",false,"NCT06551285","Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.","Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome","Inclusion Criteria:\n\n* Patients aged between 18 and 45 years.\n* Patients diagnosed with PCOS using the AE-PCOS diagnostic criteria (2009).\n* Patients who agree to participate in the study and sign the informed consent form after reading it.\n\nExclusion Criteria:\n\n* Having been treated with medication or supplementation aimed at improving PCOS prior to the study (e.g., metformin, hormonal therapy, inositol, etc.).\n* Suffering from an infectious, hematological, inflammatory, or autoimmune disease.\n* Having a severe organic disease.\n* Suffering from cardiovascular disease (heart attack, ischemia, thromboembolism).\n* Diabetes Mellitus.\n* Severe arterial hypertension.\n* Alcoholism.\n* Active smoking.",true,"FEMALE","18 Years","45 Years",{"count":74,"type":75},120,"ESTIMATED","INTERVENTIONAL",[78],"NA","Polycystic Ovary Syndrome (PCOS) is a complex endocrine-metabolic disorder characterized by elevated androgen levels due to ovarian overproduction. Although the pathophysiology of PCOS is not fully understood, it is estimated that insulin resistance (IR) occurs in 70-80% of PCOS cases, which may contribute to hyperandrogenism in affected women.\n\nWomen with PCOS and IR are more likely to develop metabolic syndrome, increasing the risk of diabetes, cardiovascular diseases, lipid profile deterioration, elevated inflammation levels, and greater oxidative stress.\n\nThe symptoms of PCOS are varied and differ among patients. Common symptoms include androgenic alopecia, hirsutism, acne, abdominal fat accumulation, and fertility issues. These physical manifestations and related problems have been associated with reduced quality of life and self-esteem in these women. The symptoms of PCOS can be improved through lifestyle changes aimed at enhancing insulin sensitivity, such as proper nutrition and regular physical exercise.\n\nSome supplements, such as a combination of Myo-inositol and D-chiro-inositol in a 40:1 ratio, are being used to support the management of PCOS because they appear to improve insulin sensitivity, as well as reduce underlying inflammation and oxidative stress.\n\nTo determine whether nutritional intervention combined with inositol supplementation improves PCOS symptoms, various variables will be analyzed to assess improvements in oxidative stress markers, inflammation, lipid profile, hormonal profile, and microbiota. Additionally, if the metabolic profile improves, it is hypothesized that this could also enhance quality of life and self-esteem.",[81,82],"Polycystic Ovary Syndrome","Metabolic Syndrome",[84,85,86,87],"Insulin resistance","Inflammation","Oxidative Stress","Intestinal microbiota","2026-03-15",{"date":90,"type":91},"2026-03-17","ACTUAL",{"date":93,"type":91},"2024-02-01",{"date":95,"type":75},"2029-05-31",{"name":60,"class":6},1]