NCT04645745

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2019

Shorter than P25 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2020

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2020

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

July 23, 2020

Completed
4 months until next milestone

First Posted

Study publicly available on registry

November 27, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

8 months

First QC Date

July 23, 2020

Last Update Submit

January 12, 2021

Conditions

Polycystic Ovary Syndrome

Keywords

Myo-inositolalpha-lactalbuminHOMA-indexovulationhyperandrogenism

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Myo-inositol and alpha-lactalbumin treatment on HOMA-index

    monitoring glucose and insulin levels in blood

    three and six months

Secondary Outcomes (2)

  • Evaluation of Myo-inositol and alpha-lactalbumin treatment on ovulation

    three and six months

  • Evaluation of Myo-inositol and alpha-lactalbumin treatment on hyperandrogenism

    three and six months

Study Arms (1)

myo-inositol plus alpha-lactalbumin

EXPERIMENTAL

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

Interventions

myo-inositol, alpha-lactalbumin, folic acidDIETARY_SUPPLEMENT

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

myo-inositol plus alpha-lactalbumin

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

AGUNCO Centre

Rome, Italy

Location

Hospital Juarez de México

Mexico City, Mexico

Location

MeSH Terms

Conditions

Polycystic Ovary SyndromeHyperandrogenism

Interventions

InositolLactalbuminFolic Acid

Condition Hierarchy (Ancestors)

Ovarian CystsCystsNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases46, XX Disorders of Sex DevelopmentDisorders of Sex DevelopmentUrogenital AbnormalitiesAdrenogenital SyndromeMale Urogenital DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Sugar AlcoholsAlcoholsOrganic ChemicalsCarbohydratesAlbuminsProteinsAmino Acids, Peptides, and ProteinsWhey ProteinsMilk ProteinsAnimal Proteins, DietaryDietary ProteinsPterinsPteridinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director

Study Record Dates

First Submitted

July 23, 2020

First Posted

November 27, 2020

Study Start

June 15, 2019

Primary Completion

January 31, 2020

Study Completion

February 28, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)ME(1)