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

Low Serum Testosterone Levels in Man Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04615767
• Other study ID #: UVittorio1
• Status: Completed
• Phase: N/A
• Start date: October 28, 2020
• Est. completion date: December 16, 2020

Study information

• Verified date: January 2021
• Source: AGUNCO Obstetrics and Gynecology Centre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: December 16, 2020
• Est. primary completion date: December 6, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 30 Years to 65 Years

Eligibility

Inclusion Criteria:

• Body mass index (BMI) range is between 22 and 34 kg/m2, in order to include subjects with normal weight, overweight and obese. Subjects with altered glycemia or hormonal status due to age or weight were enrolled in the study.

Exclusion Criteria:

• Men with poor general health were excluded from the study.

Related Conditions & MeSH terms

• Low Serum Testosterone Levels in Man

Intervention

Dietary Supplement:
• D-chiro-inositol
as described previously

Locations

Country	Name	City	State
Italy	Clinica Alma Res	Rome

Sponsors (1)

Lead Sponsor	Collaborator
AGUNCO Obstetrics and Gynecology Centre

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of the Testosterone/Estradiol ratio in serum	Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum	Thirty days
Secondary	Dehydroepiandrosterone sulfate	Detecting the serum levels of Dehydroepiandrosterone sulfate	Thirty days
Secondary	Estrone	Detecting the serum levels of Estrone	Thirty days
Secondary	Homeostatic Model Assessment for Insulin Resistance (HOMA) Index	Detecting glycemia and insulinemia	Thirty days