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

Condition(s) studied

Investigational drug(s) / intervention(s)

Ovapro (Lifepro): Dietary supplement that contains inositol, vitamin D, zinc, and curcumin.

Study 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

Primary outcome measure(s)

• Verify that nutritional intervention and inositol supplementation improve the symptoms of PCOS. — 5 years
  To assess if there is an improvement in PCOS symptoms, both PCOSQ and Ferriman-Gallwey test and regularity of menstrual cycle will be evaluated. PCOSQ result must be assessed as 7-point scales in which 7 represents optimal function and 1 represents the poorest function. Ferriman-Gallway test gives a total score, which can range from 0 to 36. A score of ≥8 si considered a sign of androgen excess in caucausian women; a score of 8-15 indicates mild hirsutism, and \>15 indicates moderate or severe hirsutism. The classification of patients between PCOS or healthy will be carried out using Rotterdam criteria.
• Evaluate the differences in the diversity of the intestinal microbiota depending on whether patients present PCOS or not. — 5 years
  To asses the differences in alpha-diversity of the intestinal microbiota in both groups, it will be evaluated whether there are significant differences between the Shannon indices of the two groups.

Trial sites (1)

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