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| Name | Class |
|---|---|
| Hospital Juarez de Mexico | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myo-inositol plus alpha-lactalbumin | Experimental | 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) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myo-inositol, alpha-lactalbumin, folic acid | Dietary Supplement | Evaluating the improvement vs the baseline after three and six months of treatment |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AGUNCO Centre | Rome | Italy | ||||
| Hospital Juarez de México |
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| ID | Term |
|---|---|
| D011085 | Polycystic Ovary Syndrome |
| D017588 | Hyperandrogenism |
| ID | Term |
|---|---|
| D010048 | Ovarian Cysts |
| D003560 | Cysts |
| D009369 | Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 |
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| ID | Term |
|---|---|
| D007294 | Inositol |
| D007768 | Lactalbumin |
| D005492 | Folic Acid |
| ID | Term |
|---|---|
| D013402 | Sugar Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D002241 | Carbohydrates |
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dosage of Total Testosterone, Free Testosterone, Androstenedione.
| three and six months |
| Mexico City |
| Mexico |
| Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D006058 | Gonadal Disorders |
| D004700 | Endocrine System Diseases |
| D058489 | 46, XX Disorders of Sex Development |
| D012734 | Disorders of Sex Development |
| D014564 | Urogenital Abnormalities |
| D047808 | Adrenogenital Syndrome |
| D052801 | Male Urogenital Diseases |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D000418 |
| Albumins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000067816 | Whey Proteins |
| D008894 | Milk Proteins |
| D000080224 | Animal Proteins, Dietary |
| D004044 | Dietary Proteins |
| D011622 | Pterins |
| D011621 | Pteridines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |