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

Not Applicable

Completed

• Conditions: Polycystic Ovary Syndrome
• Interventions: Dietary Supplement: myo-inositol, alpha-lactalbumin, folic acid

• Registration Number: NCT04645745
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

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.

Study Timeline

• Study Start: 2019-06-15
• Primary Completion: 2020-01-31
• Study Completion: 2020-02-28
• Study First Submitted: 2020-07-23
• Study First Submitted QC: 2020-11-22
• Study First Posted: 2020-11-27
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-12
• Last Update Posted: 2021-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 36

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
myo-inositol plus alpha-lactalbumin	myo-inositol, alpha-lactalbumin, folic acid	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)

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

AGUNCO Centre; 🇮🇹 Rome, Italy

Hospital Juarez de México; 🇲🇽 Ciudad de México, Mexico