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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| D-chiro-inositol | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| D-chiro-inositol | Dietary Supplement | as described previously |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Dehydroepiandrosterone sulfate | Detecting the serum levels of Dehydroepiandrosterone sulfate | Thirty days |
| Estrone | Detecting the serum levels of Estrone |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanni Monastra | Systems Biology Group Lab, Rome, Italy | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinica Alma Res | Rome | 00198 | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34078260 | Derived | 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. |
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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.
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| Thirty days |
| Homeostatic Model Assessment for Insulin Resistance (HOMA) Index | Detecting glycemia and insulinemia | Thirty days |