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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
as described previously
Clinica Alma Res
Rome, Italy
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
Time frame: Thirty days
Dehydroepiandrosterone sulfate
Detecting the serum levels of Dehydroepiandrosterone sulfate
Time frame: Thirty days
Estrone
Detecting the serum levels of Estrone
Time frame: Thirty days
Homeostatic Model Assessment for Insulin Resistance (HOMA) Index
Detecting glycemia and insulinemia
Time frame: Thirty days
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