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

NCT04615767 | Completed

• 1 other identifier: UVittorio1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Serum Testosterone Levels in Man

Keywords

Testosterone; DHEAS; Estradiol; Estrone; HOMA index; D-chiro-inositol

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Dehydroepiandrosterone sulfate

  Thirty days

• Estrone

  Thirty days

• Homeostatic Model Assessment for Insulin Resistance (HOMA) Index

  Thirty days

Study Arms (1)

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

Dietary Supplement: D-chiro-inositol

Interventions

D-chiro-inositol DIETARY_SUPPLEMENT

as described previously

D-chiro-inositol

Eligibility Criteria

• Age: 30 Years - 65 Years
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Men with poor general health were excluded from the study.

Sponsors & Collaborators

• AGUNCO Obstetrics and Gynecology Centre: lead

Study Sites (1)

Clinica Alma Res

Rome, 00198, Italy

Location

Related Publications (1)

• 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.

  PMID: 34078260 DERIVED

Study Officials

• Giovanni Monastra

  Systems Biology Group Lab, Rome, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: October 29, 2020
• First Posted: November 4, 2020
• Study Start: October 28, 2020
• Primary Completion: December 6, 2020
• Study Completion: December 16, 2020
• Last Updated: August 2, 2021

Record last verified: 2021-01

Locations

IT (1)