Status:
RECRUITING
Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome.
Lead Sponsor:
Celia Bañuls
Conditions:
Polycystic Ovary Syndrome
Metabolic Syndrome
Eligibility:
FEMALE
18-45 years
Phase:
NA
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 un...
Detailed Description
Polycystic Ovary Syndrome (PCOS) is an endocrine-metabolic disorder that affects many women of reproductive age. PCOS is not just a reproductive disorder but a systemic condition, as cases of PCOS hav...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2029
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06551285
Start Date
February 1 2024
End Date
May 31 2029
Last Update
December 5 2025
Active Locations (1)
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1
FISABIO
Valencia, Valencia, Spain, 46020