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

Primary Purpose

Polycystic Ovary Syndrome

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
myo-inositol, alpha-lactalbumin, folic acid
Sponsored by
AGUNCO Obstetrics and Gynecology Centre
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Polycystic Ovary Syndrome focused on measuring Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism

Eligibility Criteria

18 Years - 40 Years (Adult)FemaleDoes not accept 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

Sites / Locations

  • AGUNCO Centre
  • Hospital Juarez de México

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

myo-inositol plus alpha-lactalbumin

Arm Description

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)

Outcomes

Primary Outcome Measures

Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
monitoring glucose and insulin levels in blood

Secondary Outcome Measures

Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
dosage of Progesterone, LH, FSH.
Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
dosage of Total Testosterone, Free Testosterone, Androstenedione.

Full Information

First Posted
July 23, 2020
Last Updated
January 12, 2021
Sponsor
AGUNCO Obstetrics and Gynecology Centre
Collaborators
Hospital Juarez de Mexico
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1. Study Identification

Unique Protocol Identification Number
NCT04645745
Brief Title
Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS
Official Title
Effects of Myo-inositol, Alpha-Lactalbumin and Folic Acid Treatment in PCOS Women of Mexico and Italy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
January 31, 2020 (Actual)
Study Completion Date
February 28, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
AGUNCO Obstetrics and Gynecology Centre
Collaborators
Hospital Juarez de Mexico

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Polycystic Ovary Syndrome
Keywords
Myo-inositol, alpha-lactalbumin, HOMA-index, ovulation, hyperandrogenism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myo-inositol plus alpha-lactalbumin
Arm Type
Experimental
Arm Description
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)
Intervention Type
Dietary Supplement
Intervention Name(s)
myo-inositol, alpha-lactalbumin, folic acid
Intervention Description
Evaluating the improvement vs the baseline after three and six months of treatment
Primary Outcome Measure Information:
Title
Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index
Description
monitoring glucose and insulin levels in blood
Time Frame
three and six months
Secondary Outcome Measure Information:
Title
Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation
Description
dosage of Progesterone, LH, FSH.
Time Frame
three and six months
Title
Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism
Description
dosage of Total Testosterone, Free Testosterone, Androstenedione.
Time Frame
three and six months

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
AGUNCO Centre
City
Rome
Country
Italy
Facility Name
Hospital Juarez de México
City
Ciudad de México
Country
Mexico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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