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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04645745
• Other study ID #: UVittorio
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: February 28, 2020

Study information

• Verified date: January 2021
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: February 28, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Polycystic Ovary Syndrome

Intervention

Dietary Supplement:
• myo-inositol, alpha-lactalbumin, folic acid
Evaluating the improvement vs the baseline after three and six months of treatment

Locations

Country	Name	City	State
Italy	AGUNCO Centre	Rome
Mexico	Hospital Juarez de México	Ciudad de México

Sponsors (2)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre	Hospital Juarez de Mexico

Countries where clinical trial is conducted

Italy,  Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index	monitoring glucose and insulin levels in blood	three and six months
Secondary	Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation	dosage of Progesterone, LH, FSH.	three and six months
Secondary	Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism	dosage of Total Testosterone, Free Testosterone, Androstenedione.	three and six months