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Search / Trial 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.

Launched by CELIA BAÑULS · Aug 9, 2024

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Insulin Resistance Inflammation Oxidative Stress Intestinal Microbiota

ClinConnect Summary

This clinical trial is looking at how a nutritional supplement might help women with Polycystic Ovary Syndrome (PCOS), especially those who also have insulin resistance. PCOS is a condition that can cause symptoms like weight gain, acne, excess hair growth, and fertility issues, which can affect a woman’s quality of life. The researchers hope to see if a specific combination of supplements can improve these symptoms by enhancing insulin sensitivity, which is how well the body uses insulin to manage blood sugar levels, and by reducing inflammation and stress in the body.

To participate in this study, women aged 18 to 45 who have been diagnosed with PCOS according to specific criteria can sign up. However, those who have been treated with certain medications or have other serious health conditions, like diabetes or heart disease, cannot join. Participants can expect to take the supplement and undergo various tests to measure improvements in their overall health, including their hormonal and metabolic profiles. The goal is to see if these changes can lead to a better quality of life and boost self-esteem for those living with PCOS.

Gender

FEMALE

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.

About Celia Bañuls

Celia Bañuls is a dedicated clinical trial sponsor focused on advancing medical research and innovative therapies. With a commitment to enhancing patient outcomes, the organization specializes in the development and management of clinical trials across various therapeutic areas. Driven by a rigorous adherence to ethical standards and regulatory compliance, Celia Bañuls collaborates with leading research institutions and healthcare professionals to ensure the successful execution of trials. Their mission is to contribute to the body of scientific knowledge while prioritizing patient safety and well-being throughout the research process.

Locations

Valencia, Comunidad Valenciana, Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported