Study of the Effect of a Nutritional Supplement on Microbiota, Metabolic Control, Inflammatory Profile, and Quality of Life in Patients With Polycystic Ovary Syndrome

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Spain
FISABIO
RECRUITING
Valencia
Time Frame
Start Date: 2024-02-01
Estimated Completion Date: 2029-05-31
Participants
Target number of participants: 120
Treatments
Active_comparator: Dietary supplement in PCOS
Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing inositol, vitamin D, zinc, and curcumin for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).
Placebo_comparator: Placebo in PCOS
Subjects will recieve nutritional intervention by a registered dietitian and a supplement containing yellow colorant for 3 months. The dietary intervention consists of healthy dietary recommendations and hipocaloric diet if needed (overweight, obesity).
No_intervention: No intervention in healthy subjects
Healthy subjects will not recieve supplement/placebo nor dietary intervention.
Sponsors
Leads: Celia Bañuls

This content was sourced from clinicaltrials.gov