Trials / Completed
CompletedNCT04645745
Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 36 (actual)
- Sponsor
- AGUNCO Obstetrics and Gynecology Centre · Academic / Other
- Sex
- Female
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DIETARY_SUPPLEMENT | myo-inositol, alpha-lactalbumin, folic acid | Evaluating the improvement vs the baseline after three and six months of treatment |
Timeline
- Start date
- 2019-06-15
- Primary completion
- 2020-01-31
- Completion
- 2020-02-28
- First posted
- 2020-11-27
- Last updated
- 2021-01-14
Locations
2 sites across 2 countries: Italy, Mexico
Source: ClinicalTrials.gov record NCT04645745. Inclusion in this directory is not an endorsement.