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Evaluation of D-chiro-inositol Treatments

Sponsor
Lo.Li.Pharma s.r.l (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05448378
Collaborator
(none)
10
Enrollment
2
Locations
1
Arm
7
Anticipated Duration (Months)
5
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Dietary Supplement: D-chiro-inositol
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Human healthy womenHuman healthy women
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer
Actual Study Start Date :
Jun 4, 2022
Anticipated Primary Completion Date :
Aug 4, 2022
Anticipated Study Completion Date :
Jan 4, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: D-chiro-inositol

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

Outcome Measures

Primary Outcome Measures

  1. Testosterone [30 days]

    Serum values of testosterone

Secondary Outcome Measures

  1. BMI [30 days]

    body-mass index

  2. Glycemia [30 days]

    Serum values of glucose

  3. Insulinemia [30 days]

    Serum values of insulin

  4. HOMA-IR index [30 days]

    Model of assessment for insulin resistance

  5. FSH [30 days]

    Serum values of FSH

  6. LH [30 days]

    Serum values of LH

  7. Estradiol [30 days]

    Serum values of estradiol

  8. DHEAS [30 days]

    Serum values of DHEAS

  9. Asprosin [30 days]

    Serum values of asprosin

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 50 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Good state of health;

  • Regular menstrual cycle.

Exclusion Criteria:

  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 ASL Civitavecchia Roma Lazio Italy 00053
2 ALMA RES Roma Lazio Italy 00198

Sponsors and Collaborators

  • Lo.Li.Pharma s.r.l

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Lo.Li.Pharma s.r.l
ClinicalTrials.gov Identifier:
NCT05448378
Other Study ID Numbers:
  • DCI-Evaluation
First Posted:
Jul 7, 2022
Last Update Posted:
Jul 8, 2022
Last Verified:
Jul 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Inositol

Study Results

No Results Posted as of Jul 8, 2022