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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04615767
Recruitment Status : Completed
First Posted : November 4, 2020
Last Update Posted : August 2, 2021
Sponsor:
Information provided by (Responsible Party):
AGUNCO Obstetrics and Gynecology Centre

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.

Condition or disease Intervention/treatment Phase
Low Serum Testosterone Levels in Man Dietary Supplement: D-chiro-inositol Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: N/A
Intervention Model: Single Group Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: D-chiro-inositol, a Putative Aromatase Inhibitor, Increases Androgen and Reduces Estrogen Levels in Serum of Male Volunteers. A Pilot Study.
Actual Study Start Date : October 28, 2020
Actual Primary Completion Date : December 6, 2020
Actual Study Completion Date : December 16, 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Inositol

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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Dehydroepiandrosterone sulfate [ Time Frame: Thirty days ]
    Detecting the serum levels of Dehydroepiandrosterone sulfate

  2. Estrone [ Time Frame: Thirty days ]
    Detecting the serum levels of Estrone

  3. Homeostatic Model Assessment for Insulin Resistance (HOMA) Index [ Time Frame: Thirty days ]
    Detecting glycemia and insulinemia



Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04615767


Locations
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Italy
Clinica Alma Res
Rome, Italy, 00198
Sponsors and Collaborators
AGUNCO Obstetrics and Gynecology Centre
Investigators
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Principal Investigator: Giovanni Monastra Systems Biology Group Lab, Rome, Italy
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: AGUNCO Obstetrics and Gynecology Centre
ClinicalTrials.gov Identifier: NCT04615767    
Other Study ID Numbers: UVittorio1
First Posted: November 4, 2020    Key Record Dates
Last Update Posted: August 2, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by AGUNCO Obstetrics and Gynecology Centre:
Testosterone
DHEAS
Estradiol
Estrone
HOMA index
D-chiro-inositol
Additional relevant MeSH terms:
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Inositol
Vitamin B Complex
Vitamins
Micronutrients
Physiological Effects of Drugs