Low Serum Testosterone Levels in Man
Conditions
Keywords
Testosterone, DHEAS, Estradiol, Estrone, HOMA index, D-chiro-inositol
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.
Interventions
DIETARY_SUPPLEMENTD-chiro-inositol
as described previously
Sponsors
AGUNCO Obstetrics and Gynecology Centre
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
MALE
Age
30 Years to 65 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Dehydroepiandrosterone sulfate | Thirty days | Detecting the serum levels of Dehydroepiandrosterone sulfate |
| Estrone | Thirty days | Detecting the serum levels of Estrone |
| Homeostatic Model Assessment for Insulin Resistance (HOMA) Index | Thirty days | Detecting glycemia and insulinemia |
Countries
Italy
Outcome results
None listed