RecruitingNot ApplicableNCT06551285

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

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


Sponsor

Celia Bañuls

Enrollment

120 participants

Start Date

Feb 1, 2024

Study Type

INTERVENTIONAL

Conditions

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

Sex: FEMALEMin Age: 18 YearsMax Age: 45 Years

Inclusion Criteria3

  • 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 Criteria8

  • 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.

Interventions

DIETARY_SUPPLEMENTOvapro (Lifepro)

Dietary supplement that contains inositol, vitamin D, zinc, and curcumin.


Locations(1)

FISABIO

Valencia, Valencia, Spain

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NCT06551285


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