Evaluation of D-chiro-inositol Treatments

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

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.

Study Overview

• Status: Completed
• Conditions: Insulin; Ovulation; Testosterone; Inositol; Asprosin
• Intervention / Treatment: Dietary supplement: D-chiro-inositol

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Lazio
    • Roma, Lazio, Italy, 00053
      • ASL Civitavecchia
    • Roma, Lazio, Italy, 00198
      • ALMA RES

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Testosterone	Serum values of testosterone	30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
BMI	body-mass index	30 days
Glycemia	Serum values of glucose	30 days
Insulinemia	Serum values of insulin	30 days
HOMA-IR index	Model of assessment for insulin resistance	30 days
FSH	Serum values of FSH	30 days
LH	Serum values of LH	30 days
Estradiol	Serum values of estradiol	30 days
DHEAS	Serum values of DHEAS	30 days
Asprosin	Serum values of asprosin	30 days

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): September 16, 2022

Study Registration Dates

• First Submitted: July 4, 2022
• First Submitted That Met QC Criteria: July 4, 2022
• First Posted (Actual): July 7, 2022

Study Record Updates

• Last Update Posted (Actual): September 19, 2022
• Last Update Submitted That Met QC Criteria: September 16, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Inositol
• Other Study ID Numbers: DCI-Evaluation

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No