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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-28

Study Completion Date

2020-12-16

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Low Serum Testosterone Levels in Man

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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 Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

D-chiro-inositol

Intervention Type DIETARY_SUPPLEMENT

as described previously

Interventions

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D-chiro-inositol

as described previously

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.