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OpenTrials
Completed

NCT Number: NCT05448378

Evaluation of D-chiro-inositol Treatments

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.

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Key information

Conditions

Inositol Arachnodactyly Asprosin Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Glucose Metabolism Disorders Hyperinsulinism Insulin Insulin Resistance Limb Deformities, Congenital Metabolic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Nutritional and Metabolic Diseases Ovulation Testosterone

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

ALMA RES, Rome, Lazio, Italy

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

D-chiro-inositol

Dietary Supplement

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

Primary outcomes

  1. Testosterone

    Time frame: 30 days

    Serum values of testosterone

Secondary outcomes

  1. BMI

    Time frame: 30 days

    body-mass index

  2. Glycemia

    Time frame: 30 days

    Serum values of glucose

  3. Insulinemia

    Time frame: 30 days

    Serum values of insulin

  4. HOMA-IR index

    Time frame: 30 days

    Model of assessment for insulin resistance

  5. FSH

    Time frame: 30 days

    Serum values of FSH

  6. LH

    Time frame: 30 days

    Serum values of LH

  7. Estradiol

    Time frame: 30 days

    Serum values of estradiol

  8. DHEAS

    Time frame: 30 days

    Serum values of DHEAS

  9. Asprosin

    Time frame: 30 days

    Serum values of asprosin

Sponsors and collaborators

Lead sponsor

Lo.Li.Pharma s.r.l

Industry

Registry information

Official study title

Evaluation of the Effects of D-chiro-inositol in Female Healthy Volunteer

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Jul 7, 2022
Registry last updated
Sep 19, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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