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.
| NCT ID | NCT06551285 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Celia Bañuls |
| Condition | Polycystic Ovary Syndrome |
| Study Type | INTERVENTIONAL |
| Enrollment | 120 participants |
| Start Date | 2024-02-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 120 participants in total. It began in 2024-02-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 improved through lifestyle changes aimed at enhancing insulin sensitivity, such as proper nutrition and regular physical exercise. Some 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. To 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.
Eligibility Criteria
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.
Frequently Asked Questions
Who can join the NCT06551285 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Polycystic Ovary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06551285 currently recruiting?
Yes, NCT06551285 is actively recruiting participants. Visit ClinicalTrials.gov or contact Celia Bañuls to inquire about joining.
Where is the NCT06551285 trial being conducted?
This trial is being conducted at Valencia, Spain.
Who is sponsoring the NCT06551285 clinical trial?
NCT06551285 is sponsored by Celia Bañuls. The trial plans to enroll 120 participants.