Effect of a nutritional supplement on women with Polycystic Ovary Syndrome
Official title: Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome
Run by Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana · NCT06551285 · Data updated 2026-11-12
This study is testing whether a nutritional supplement can help women with Polycystic Ovary Syndrome feel better and improve their health.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 45 Years |
| Sex | Women only |
| Enrollment | 120 (estimated) |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 31, 2026 |
| Study ends | May 31, 2029 |
| Registry record updated | March 17, 2026 |
| Trial ID | NCT06551285 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are women aged 18 to 45 diagnosed with PCOS according to the AE-PCOS criteria.
✕Probably not a fit
Patients with severe organic diseases, diabetes, or those who have previously received treatment for PCOS may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study investigates the impact of a nutritional supplement on the microbiota, metabolic control, inflammatory profile, and quality of life in women diagnosed with Polycystic Ovary Syndrome (PCOS). It focuses on patients aged 18 to 45 who meet specific diagnostic criteria for PCOS. The study aims to assess how the supplement may improve insulin sensitivity and reduce symptoms associated with PCOS, which can include metabolic syndrome and related health risks. Participants will be monitored for changes in their health and quality of life throughout the intervention.
Why it matters
Potential benefit: If successful, this study could provide a new nutritional approach to managing symptoms and improving the quality of life for women with PCOS.
How similar studies have gone: While there have been studies exploring nutritional interventions in PCOS, this specific approach focusing on microbiota and metabolic control is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
Fisabio
Valencia, Valencia, Spain Recruiting
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.