Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS

AGUNCO Obstetrics and Gynecology Centre36 enrolled

Overview

The main aim of this study is to evaluate the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of women, belonging to the Mexican and Italian population, both affected by Polycystic Ovary Syndrome.

This is an open-label clinical trial aimed at evaluating and comparing the effect of myo-inositol and alpha-lactalbumin treatment on HOMA-index improvement in two different groups of PCOS patients from the Mexican and Italian population. The addition of alpha-lactalbumin helps to increase the intestinal absorption of myo-inositol and consequently improve its effect. The scientific evidence so far available shows that these two groups of PCOS women have a different genetic, nutritional, and behavioural profile. Important factors are body mass index and insulin resistance, both increased in the Mexican women, although among them PCOS prevalence is not higher compared to many other populations. Therefore, the focus of this study is to check the effects of the combined administration of myo-inositol and alpha-lactalbumin for six months (with a control at three months) e to compare these effects between the two groups of patients, monitoring several hormonal parameters connected to the menstrual cycle regularization.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polycystic Ovary Syndrome

Interventions

myo-inositol, alpha-lactalbumin, folic acidDIETARY_SUPPLEMENT

Evaluating the improvement vs the baseline after three and six months of treatment

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

Inclusion Criteria: * PCOS diagnosis based on the Rotterdam ESHRE-ASRM consensus workshop group1. * Presence of Insulin resistance diagnosed by HOMA-Index * Patients belonging to the Mexican population * Patients belonging to the Italian population Exclusion Criteria: * BMI ≥ 30 * Other conditions causing ovulatory disorders and/or androgens hyper production such as: hyperprolactinemia, hypothyroidism, adrenal hyperplasia and Cushing syndrome * Hormonal and/or pharmacological treatments in the previous 3 months that could interfere with ovulation * Drastic changes in diet and physical activity * Treatment with products containing inositols in the previous 3 months

Locations (2)

AGUNCO Centre

Rome, Italy

Hospital Juarez de México

Mexico City, Mexico

Outcomes

Primary Outcomes

Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index

monitoring glucose and insulin levels in blood

Time frame: three and six months

Secondary Outcomes

Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation

dosage of Progesterone, LH, FSH.

Time frame: three and six months

Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism

dosage of Total Testosterone, Free Testosterone, Androstenedione.

Time frame: three and six months

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.