Clinical trial NCT04615767: D-chiro-inositol Increases Androgens and Reduces Estrogens in Human Serum
Official title: D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Serum Testosterone Levels in Man
Keywords: Testosterone
DHEAS
Estradiol
Estrone
HOMA index
D-chiro-inositol
Lead sponsor: AGUNCO Obstetrics and Gynecology Centre
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 10
Sex: MALE
Minimum age (years): 30
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Ten male volunteers are treated daily with 1 g D-chiro-inositol for 30 days (2 capsules containing 500 mg each, twice a day). The serum levels of the detected parameters at the end of treatment are compared to the values found in the volunteers at the baseline, used as controls. Parameters under analysis: Testosterone/Estradiol ratio, Testosterone, dehydroepiandrosterone, estradiol, estrone, glycemia and insulinemia with Homeostatic Model Assessment for Insulin Resistance (HOMA) index, follicle stimulating hormone, luteinizing hormone, D-chiro-inositol and myo-inositol.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Improvement of the Testosterone/Estradiol ratio in serum
timeFrame: Thirty days
Secondary outcomes:
measure: Dehydroepiandrosterone sulfate
timeFrame: Thirty days
measure: Estrone
timeFrame: Thirty days
measure: Homeostatic Model Assessment for Insulin Resistance (HOMA) Index
timeFrame: Thirty days
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Clinica Alma Res
Study officials:
affiliation: Systems Biology Group Lab, Rome, Italy
name: Giovanni Monastra
role: PRINCIPAL_INVESTIGATOR
References:
citation: Monastra G, Vazquez-Levin M, Bezerra Espinola MS, Bilotta G, Lagana AS, Unfer V. D-chiro-inositol, an aromatase down-modulator, increases androgens and reduces estrogens in male volunteers: a pilot study. Basic Clin Androl. 2021 Jun 3;31(1):13. doi: 10.1186/s12610-021-00131-x.