[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Celia Bañuls\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":78},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":24,"briefSummary":26,"conditions":27,"keywords":30,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"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":21,"type":22},120,"ESTIMATED","INTERVENTIONAL",[25],"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.",[28,29],"Polycystic Ovary Syndrome","Metabolic Syndrome",[31,32,33,34],"Insulin resistance","Inflammation","Oxidative Stress","Intestinal microbiota","RECRUITING","2026-03-15",{"date":38,"type":39},"2026-03-17","ACTUAL",{"date":41,"type":39},"2024-02-01",{"date":43,"type":22},"2029-05-31",{"name":45,"class":46},"Celia Bañuls","OTHER",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":11,"sex":55,"minAge":18,"maxAge":56,"enrollmentInfo":57,"targetDuration":4,"studyType":23,"phases":58,"briefSummary":59,"conditions":60,"keywords":64,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":47},"100585390","therapeutic-potential-of-a-synbiotic-to-improve-mental-health-in-subjects-with-obesity-100585390","NCT06901739","Therapeutic Potential of a Synbiotic to Improve Mental Health in Subjects With Obesity.","New Dietary Intervention Strategies on the Intestinal Microbiota to Improve Mental Health Subjects With Obesity: Therapeutic Potential of a Synbiotic.","Inclusion Criteria:\n\n* Patients with BMI 30-40kg\u002Fm2, with at least 5 years of diagnosed obesity evolution.\n* Patients have had stable body weight (\\\u003C5% of body weight changes) during the 3 months prior to the study.\n* Participants between 18 and 65 years of age.\n\nExclusion Criteria:\n\n* All patients with acute or chronic inflammatory diseases, neoplasic disease, secondary causes of obesity (uncontrolled hypothyroidism, Cushing's syndrome), or established liver and kidney failure (according to transaminase levels ±2 SD of the mean and estimated glomerular filtration rate using the CKD-EPI formula \\>60), previous bariatric surgery, and women during pregancy or lactation, will be excluded.\n* Participants who have been treated with antibiotics 3 months prior to inclusion.\n* Patients with different psychiatric disorders apart from anxiety and\u002For depression, and also those who are already on antidepressants before the inclusion.","ALL","65 Years",{"count":21,"type":22},[25],"Obese individuals are a particularly vulnerable population for mental health problems, especially depression and anxiety. The aim of this study is to evaluate whether the intake of a synbiotic, composed of prebiotics and beneficial intestinal bacterial strains, is capable of producing changes in the gut microbiota and its functionality, improving metabolic and inflammatory parameters, intestinal function and appetite control in patients with obesity and psychological disorders. In addition, the production of neurotransmitters at the level of the gut-brain axis will be studied, as well as mood and quality of life. For this purpose, a prospective, randomized, doubleblind, placebo-controlled intervention study will be carried out in patients with obesity (BMI=30-40 kg\u002Fm2) and symptoms of anxiety and\u002For depression, or patients with obesity but without these psychological disorders (n=120). The groups will be randomly divided into two groups (n=60) according to the intake of a synbiotic (1 capsule\u002Fday composed of bifidobacterium, Lactobacillus and tannin-based phytocomplexes) or its corresponding placebo for 12 weeks. Individualized psychological and nutritional follow-up will be carried out, demographic, lifestyle and mental health variables will be collected, and biological samples will be collected before and after the intervention. In addition, all patients will undergo an assessment of body composition and nutritional status, together with cardiovascular risk factors and comorbidities (hypertension, dyslipidemia, DM2, insulin resistance). Inflammatory parameters (IL6, TNF , IL1b, adiponectin, PAI-1, IL10, resistin, adipsin), antioxidant capacity, intestinal function (zonulin, LPS, occludin, LBP, FABP2\u002FI-FABP, -glucan, Reg3A), satiety, appetite control (Leptin, GLP1, GIP, Ghrelin, PP) and neurotransmitter production (cortisol, dopamine, serotonin, oxytocin) in plasma\u002Fserum, urine or saliva using ELISA Kits and Luminex XMAP technology will be analyzed. In addiition, the investigators will perform analysis of genetic markers of inflammatory and metabolic pathways (Nanostring technology), metabolomic profiling (NMR spectroscopy and PLS-DA) in plasma, and both content and diversity of the intestinal microbiota (16S rRNA amplicons, and direct metagenomic sequencing, with Illumina MiSeq technology) in faeces will be evaluated.\n\nFinally, the investigators will study in vitro the mechanism of action of colonic digest on complex cellular models that simulate the gut-brain axis (organ-on-chip model, OoC).",[61,62,63],"Obese Patients (BMI ≥ 30 kg\u002Fm²)","Anxiety","Depressive Disorder",[65,32,66,67,68,69],"Microbiota","Symbiotic","Tannins","Mental disorders","Obesity","2025-08-04",{"date":72,"type":39},"2025-08-05",{"date":74,"type":39},"2025-04-15",{"date":76,"type":22},"2027-12-31",{"name":45,"class":46},""]