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

Sponsor

AGUNCO Obstetrics and Gynecology Centre (Other)

Overall Status

Completed

CT.gov ID

NCT04645745

Collaborator

Hospital Juarez de Mexico (Other)

Enrollment

Locations

Arm

8.5

Actual Duration (Months)

Patients Per Site

2.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Polycystic Ovary Syndrome	Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

36 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jun 15, 2019

Actual Primary Completion Date :

Jan 31, 2020

Actual Study Completion Date :

Feb 28, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: myo-inositol plus alpha-lactalbumin 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 Evaluating the improvement vs the baseline after three and six months of treatment

Arm

Intervention/Treatment

Experimental: myo-inositol plus alpha-lactalbumin

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

Evaluating the improvement vs the baseline after three and six months of treatment

Outcome Measures

Primary Outcome Measures

Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index [three and six months]
monitoring glucose and insulin levels in blood

Secondary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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