NCT05448378

Brief Summary

Healthy women will take tablets containing 600 mg D-chiro-inositol twice per day for one month. We will evaluate metabolic and hormonal.parameters, as insulienmia, glycemia, estradiol, testosterone.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

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 4, 2022

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

July 4, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 16, 2022

Completed
Last Updated

September 19, 2022

Status Verified

July 1, 2022

Enrollment Period

3 months

First QC Date

July 4, 2022

Last Update Submit

September 16, 2022

Conditions

InositolTestosteroneInsulinOvulationAsprosin

Outcome Measures

Primary Outcomes (1)

  • Testosterone

    Serum values of testosterone

    30 days

Secondary Outcomes (9)

  • BMI

    30 days

  • Glycemia

    30 days

  • Insulinemia

    30 days

  • HOMA-IR index

    30 days

  • FSH

    30 days

  • +4 more secondary outcomes

Study Arms (1)

D-chiro-inositol

EXPERIMENTAL

Patients will take D-chiro-inositol. We will make two blood sampling, at the baseline and after one-month treatment

Dietary Supplement: D-chiro-inositol

Interventions

D-chiro-inositolDIETARY_SUPPLEMENT

D-chiro-inositol 600 mg twice per day on an empty stomach for one month

D-chiro-inositol

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Good state of health;
  • Regular menstrual cycle.

You may not qualify if:

  • pregnancy;
  • delivery in the previous 6 months;
  • currently breastfeeding;
  • menopause;
  • alcohol or drug abuse;
  • insulin resistance defined as HOMA-IR index greater than or equal to 2.5;
  • other medical morbidities, such as hypertension, PCOS, or diabetes;
  • oligomenorrhea or amenorrhea;
  • current treatment with corticosteroids or hormones (oral contraceptives, estrogensic, progestogensin);
  • use of GnRH analogues, SERMs, or SPRMs within the previous 6 months.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

ASL Civitavecchia

Rome, Lazio, 00053, Italy

Location

ALMA RES

Rome, Lazio, 00198, Italy

Location

MeSH Terms

Conditions

Insulin ResistanceArachnodactyly

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesLimb Deformities, CongenitalMusculoskeletal AbnormalitiesMusculoskeletal DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Model Details: Human healthy women
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 4, 2022

First Posted

July 7, 2022

Study Start

June 4, 2022

Primary Completion

August 30, 2022

Study Completion

September 16, 2022

Last Updated

September 19, 2022

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

IT(2)