NCT04615767

D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum

D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: AGUNCO Obstetrics and Gynecology Centre · Academic / Other
• Sex: Male
• Age: 30 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The aim of this pilot study is to test the effect of a 30 day-D-chiro-inositol oral treatment on a set of clinical parameters (mainly sex hormones) in a group of male volunteers selected by their age and BMI to investigate if D-chiro-inositol acts as an aromatase inhibitor.

Detailed description

This is an open label clinical trial with a dietary supplement carried out in male volunteers selected by their age and BMI. The aim is to test the effect of oral daily treatment with 1 g D-chiro-inositol for 30 days on some clinical parameters, to see if D-chiro-inositol acts as an aromatase inhibitor. Testosterone, estradiol, Testosterone/Estradiol ratio, Dehydroepiandrosterone sulfate, Estrone, glycemia and insulinemia (with calculation of HOMA index), follicle-stimulating hormone, Luteinizing hormone, D-chiro-inositol and Myo-inositol serum concentrations have to be determined before and after D-chiro-inositol administration. We wish to evaluate if this treatment for one month is able to change the sexual hormone levels, increasing androgens and decreasing estrogens. Furthermore, we wish to control the safety profile of D-chiro-inositol, a well-known molecule, different from the classic aromatase inhibitors. We think that our pilot study can open up new perspectives of research and therapeutic applications for this many-sided molecule.

Conditions

• Low Serum Testosterone Levels in Man

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	D-chiro-inositol	as described previously

Timeline

• Start date: 2020-10-28
• Primary completion: 2020-12-06
• Completion: 2020-12-16
• First posted: 2020-11-04
• Last updated: 2021-08-02

Locations

1 site across 1 country: Italy