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

July 30, 2021 updated by: AGUNCO Obstetrics and Gynecology Centre

D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Rome, Italy, 00198
        • Clinica Alma Res

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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
Dietary supplement: D-chiro-inositol
as described previously

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Improvement of the Testosterone/Estradiol ratio in serum
Time Frame: Thirty days
Assessment of the D-Chiro-Inositol treatment to increase the Testosterone/Estradiol ratio by detecting these physiological parameters in serum
Thirty days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dehydroepiandrosterone sulfate
Time Frame: Thirty days
Detecting the serum levels of Dehydroepiandrosterone sulfate
Thirty days
Estrone
Time Frame: Thirty days
Detecting the serum levels of Estrone
Thirty days
Homeostatic Model Assessment for Insulin Resistance (HOMA) Index
Time Frame: Thirty days
Detecting glycemia and insulinemia
Thirty days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AGUNCO Obstetrics and Gynecology Centre

Investigators

  • Principal Investigator: Giovanni Monastra, Systems Biology Group Lab, Rome, Italy

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2020

Primary Completion (Actual)

December 6, 2020

Study Completion (Actual)

December 16, 2020

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

November 3, 2020

First Posted (Actual)

November 4, 2020

Study Record Updates

Last Update Posted (Actual)

August 2, 2021

Last Update Submitted That Met QC Criteria

July 30, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UVittorio1

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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