Effect of a nutritional supplement on women 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
This study is testing whether a nutritional supplement can help women with Polycystic Ovary Syndrome feel better and improve their health.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana Academic / other |
| Locations | 1 site (Valencia, Valencia) |
| Trial ID | NCT06551285 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are women aged 18 to 45 diagnosed with PCOS according to the AE-PCOS criteria.
Not a fit: Patients with severe organic diseases, diabetes, or those who have previously received treatment for PCOS may not benefit from this study.
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 performed: While there have been studies exploring nutritional interventions in PCOS, this specific approach focusing on microbiota and metabolic control is relatively novel.
Eligibility criteria
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 this trial is running
Valencia, Valencia
- Fisabio — Valencia, Valencia, Spain (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.