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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy

Conditions
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Polycystic Ovary Syndrome

Intervention / Treatment
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* Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myo-inositol plus alpha-lactalbumin<br>Patients were treated with 2 g myo-inositol, 50 mg alpha-LA and 200 mcg of Folic Acid twice a day for 6 months. Controls were the same patients at baseline (t0) | Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid<br>* Evaluating the improvement vs the baseline after three and six months of treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index | monitoring glucose and insulin levels in blood | three and six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation | dosage of Progesterone, LH, FSH. | three and six months | 
| Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism | dosage of Total Testosterone, Free Testosterone, Androstenedione. | three and six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism