Evaluation of D-chiro-inositol Treatments

Insulin Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448378
• Other study ID #: DCI-Evaluation
• Status: Completed
• Phase: N/A
• Start date: June 4, 2022
• Est. completion date: September 16, 2022

Study information

• Verified date: July 2022
• Source: Lo.Li.Pharma s.r.l
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 16, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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.

Related Conditions & MeSH terms

• Inositol
• Insulin
• Ovulation
• Testosterone

Intervention

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

Locations

Country	Name	City	State
Italy	ALMA RES	Roma	Lazio
Italy	ASL Civitavecchia	Roma	Lazio

Sponsors (1)

Lead Sponsor	Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Testosterone	Serum values of testosterone	30 days
Secondary	BMI	body-mass index	30 days
Secondary	Glycemia	Serum values of glucose	30 days
Secondary	Insulinemia	Serum values of insulin	30 days
Secondary	HOMA-IR index	Model of assessment for insulin resistance	30 days
Secondary	FSH	Serum values of FSH	30 days
Secondary	LH	Serum values of LH	30 days
Secondary	Estradiol	Serum values of estradiol	30 days
Secondary	DHEAS	Serum values of DHEAS	30 days
Secondary	Asprosin	Serum values of asprosin	30 days