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

Not Applicable

Completed

• Conditions: Low Serum Testosterone Levels in Man
• Interventions: Dietary Supplement: D-chiro-inositol

• Registration Number: NCT04615767
• Lead Sponsor: AGUNCO Obstetrics and Gynecology Centre

Brief 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.

Study Timeline

• Study Start: 2020-10-28
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-11-03
• Study First Posted: 2020-11-04
• Primary Completion: 2020-12-06
• Study Completion: 2020-12-16
• Status Verified: 2021-01
• Last Update Submitted: 2021-07-30
• Last Update Posted: 2021-08-02

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
D-chiro-inositol	D-chiro-inositol	Volunteers are orally administered with 1 g D-chiro-inositol per day (two doses in capsules of 500 mg each, one in the morning and the other one in the evening) for thirty days

Primary Outcome Measures

Name	Time	Method
Improvement of the Testosterone/Estradiol ratio in serum	Thirty days	Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum

Secondary Outcome Measures

Name	Time	Method
Homeostatic Model Assessment for Insulin Resistance (HOMA) Index	Thirty days	Detecting glycemia and insulinemia
Estrone	Thirty days	Detecting the serum levels of Estrone
Dehydroepiandrosterone sulfate	Thirty days	Detecting the serum levels of Dehydroepiandrosterone sulfate

Trial Locations

Locations (1)

Clinica Alma Res; 🇮🇹 Rome, Italy