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

January 12, 2021 updated by: Unfer Vittorio, AGUNCO Obstetrics and Gynecology Centre

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy
        • AGUNCO Centre
  • Mexico
      • Ciudad de México, Mexico
        • Hospital Juarez de Mexico

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
Time Frame: three and six months
monitoring glucose and insulin levels in blood
three and six months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
Time Frame: three and six months
dosage of Progesterone, LH, FSH.
three and six months
Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
Time Frame: three and six months
dosage of Total Testosterone, Free Testosterone, Androstenedione.
three and six months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Collaborators

Hospital Juarez de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2019

Primary Completion (Actual)

January 31, 2020

Study Completion (Actual)

February 28, 2020

Study Registration Dates

First Submitted

July 23, 2020

First Submitted That Met QC Criteria

November 22, 2020

First Posted (Actual)

November 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVittorio

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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