Polycystic Ovary Syndrome
Conditions
Keywords
Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism
Brief summary
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.
Detailed description
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.
Interventions
DIETARY_SUPPLEMENTmyo-inositol, alpha-lactalbumin, folic acid
Evaluating the improvement vs the baseline after three and six months of treatment
Sponsors
Hospital Juarez de Mexico
AGUNCO Obstetrics and Gynecology Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 40 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index | three and six months | monitoring glucose and insulin levels in blood |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation | three and six months | dosage of Progesterone, LH, FSH. |
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism | three and six months | dosage of Total Testosterone, Free Testosterone, Androstenedione. |
Countries
Italy, Mexico
Outcome results
None listed