Evaluation of D-chiro-inositol Treatments

Not Applicable

Completed

• Conditions: Inositol; Ovulation; Asprosin; Testosterone; Insulin
• Interventions: Dietary Supplement: D-chiro-inositol

• Registration Number: NCT05448378
• Lead Sponsor: Lo.Li.Pharma s.r.l

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-04
• Status Verified: 2022-07
• Study First Submitted: 2022-07-04
• Study First Submitted QC: 2022-07-04
• Study First Posted: 2022-07-07
• Primary Completion: 2022-08-30
• Study Completion: 2022-09-16
• Last Update Submitted: 2022-09-16
• Last Update Posted: 2022-09-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 10

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Testosterone	30 days	Serum values of testosterone

Secondary Outcome Measures

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

Trial Locations

Locations (2)

ASL Civitavecchia; 🇮🇹 Roma, Lazio, Italy

ALMA RES; 🇮🇹 Roma, Lazio, Italy