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Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.

RecruitingNAAges 18 Years - 45 YearsFemaleCelia Bañuls
NCT06551285 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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. Women 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. The 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 im

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📋 Eligibility rules (as published)
Inclusion Criteria: * Patients aged between 18 and 45 years. * Patients diagnosed with PCOS using the AE-PCOS diagnostic criteria (2009). * Patients who agree to participate in the study and sign the informed consent form after reading it. Exclusion Criteria: * Having been treated with medication or supplementation aimed at improving PCOS prior to the study (e.g., metformin, hormonal therapy, inositol, etc.). * Suffering from an infectious, hematological, inflammatory, or autoimmune disease. * Having a severe organic disease. * Suffering from cardiovascular disease (heart attack, ischemia, thromboembolism). * Diabetes Mellitus. * Severe arterial hypertension. * Alcoholism. * Active smoking.
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What it tests

  • Ovapro (Lifepro)
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Where

1 site
FISABIO
Valencia, Spain
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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