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.
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.
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).
Parallel
Ovapro (Lifepro)
Dietary supplementDietary supplement that contains inositol, vitamin D, zinc, and curcumin.
Verify that nutritional intervention and inositol supplementation improve the symptoms of PCOS.
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.
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.
Evaluate significant changes in body fat mass percentage after the dietetic intervention and dietetic supplement.
Percentage of body fat mass will be measured by bioelectrical impedance. It is considered to be high when ≥30% in women. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.
Assess significant changes in high-sensitivity C-reactive protein (hs-CRP) as an inflammatory parameter after the dietary intervention and dietetic supplement.
Participants will be considered to have achieved an improvement in high-sensitivity C-reactive protein levels if they normalize its value (normality values defined between 0 and 1.69mg/dl).
Evaluate significant changes in C3 protein as an inflammatory parameter after the dietetic intervention and dietetic supplement.
Participants will be considered to have achieved an improvement in C3 protein if they normalize its value (normality values defined between 81 and 157mg/dl).
Evaluate significant changes in interleukin 1-beta (IL-1B) levels as a pro-inflammatory molecule after the dietetic intervention and dietetic supplement.
IL-1B levels will be measured using the Luminex® 200 analyzer system. A significant improvement will be considered when notable differences are observed in the mean values between groups measured through p-value (\<0.05) with a 95% confidence interval.
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Celia Bañuls
Lead sponsor
Fundación para el Fomento de la Investigación Sanitaria y Biomédica de la Comunitat Valenciana
Sponsor institution
