Tests a nutritional supplement in women with polycystic ovary syndrome
Tests a nutritional supplement in women with polycystic ovary syndrome and metabolic syndrome.
Plain-language title generated from the registry record
Registry 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.
Key facts
- Where
- Valencia, SpainSee the site
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for women aged 18 to 45 with polycystic ovary syndrome (PCOS) who have not yet been treated for it. It tests a nutritional supplement.
- Age
- 18 to 45 years
- Sex
- Women only
- Disease stage
- PCOS diagnosed with the AE-PCOS criteria (2009)
- Earlier treatment
- Cannot have had medicine or supplements to improve PCOS before the study, for example metformin, hormonal therapy or inositol
Main reasons for not taking part
- Earlier treatment for PCOS with medicine or supplements
- Infectious, blood, inflammatory or autoimmune disease
- Severe organic disease
- Cardiovascular disease (heart attack, ischemia, thromboembolism)
- Diabetes mellitus, severe high blood pressure, alcoholism or active smoking
Read by machine on 12 November 2026.
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 45 years old?
Source: NCT06551285, who can take part
Where in Spain
- FISABIOValencia, SpainContact: Celia Bañuls, PhDTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Celia Bañuls
- Trial code
- NCT06551285
- Record updated
- 17 March 2026
- Original description
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.Read full original descriptionShow less
Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome
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.
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.