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

NCT ID: NCT04645745

Last Updated: 2021-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2020-02-28

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.

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

Polycystic Ovary Syndrome

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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)

Group Type: EXPERIMENTAL

myo-inositol, alpha-lactalbumin, folic acid

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

myo-inositol, alpha-lactalbumin, folic acid

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Hospital Juarez de Mexico

OTHER_GOV

Sponsor Role: collaborator

AGUNCO Obstetrics and Gynecology Centre

OTHER

Sponsor Role: lead

Responsible Party

Unfer Vittorio

Director

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

AGUNCO Centre

Rome, , Italy

Hospital Juarez de México

Mexico City, , Mexico

Countries

Italy; Mexico

Other Identifiers

UVittorio

Identifier Type: -

Identifier Source: org_study_id