D-chiroinositol Administration in Hypogonadal Males

D-chiroinositol Administration for Testosterone Level Improvement in Hypogonadal Males

D-chiroinositol (DCI), is known as second messenger of insulin pathway, but recently several works have reported the influence of DCI on steroidogenesis. In particular, the DCI capabilities to regulate aromatase expression and testosterone biosynthesis are arising. In this regard, DCI administration in case of reduced levels of testosterone, could be a good therapeutic opportunity. For this reason, the treatment of Late-Onset Male Hypogonadism (LOH) in undoubtedly an interesting target. LOH is a reduction of testosterone level due to advancing age, currently treated with Testosterone Replacement Therapy (TRT). Unfortunately, there is a lack of information about TRT safety, especially in older men. For these reasons, the aim of this study is to evaluate the effect of DCI treatment on testosterone accumulation in LOH patient.

Study Overview

• Status: Completed
• Conditions: Sexual Dysfunction; Male Hypogonadism
• Intervention / Treatment: Dietary supplement: D-chiroinositol

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years to 75 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Men, with a diagnosis of Late-Onset Male Hypogonadism
• Insulin resistance (HOMA Index > 2,5)
• BMI between 25 and 30

Exclusion Criteria:

• Alcohol intake and/or drug abuse
• Recent hormonal treatment
• Smoking
• Obesity
• Systemic or endocrine diseases
• Male accessory gland infection
• Clinical history of cryptorchidism or varicocele and micro-orchidism

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: D-chiroinositol treatment	Dietary supplement: D-chiroinositol; Supplementation with 600 mg of D-chiroinositol, two-times daily on an empty stomach, for 30 days.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Serum Testosterone at 1 month	Level of testosterone detected in the blood in ng/dL	At baseline and after 30 days of treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline Weight at 1 month	Body weight of patients reported in kg	At baseline and after 30 days of treatment
Change from Baseline Waist circumference at 1 month	Waist circumference of patients reported in cm	At baseline and after 30 days of treatment
Change from Baseline BMI at 1 month	Body Mass Index of patients calculated as kg/m2, where kg is the weight measured for eah patient while m2 is his height squared	At baseline and after 30 days of treatment
Change from Baseline Insulin at 1 month	Level of fasting insulin detected in the blood and reported in microU/L	At baseline and after 30 days of treatment
Change from Baseline Glycaemia at 1 month	Level of fasting glycaemia detected in the blood and reported in mg/dL	At baseline and after 30 days of treatment
Change from Baseline HOMA index at 1 month	HOMA index known as Homeostatic Model Assessment for Insulin Resistance is: (fasting glycaemia x fasting insulin)/405	At baseline and after 30 days of treatment
Change from Baseline Androstenedione at 1 month	Level of androstenedione detected in the blood and reported in ng/mL	At baseline and after 30 days of treatment
Change from Baseline Luteinizing Hormone at 1 month	Level of luteinizing hormone detected in the blood and reported in mUI/ml	At baseline and after 30 days of treatment
Change from Baseline Oestradiol at 1 month	Level of oestradiol detected in the blood and reported in pg/mL	At baseline and after 30 days of treatment
Change from Baseline Oestrone at 1 month	Level of oestrone detected in the blood and reported in pg/mL	At baseline and after 30 days of treatment
Change from Baseline Testosterone/Oestradiol ratio at 1 month	Ratio between the levels of oestradiol and testosterone detected in the blood	At baseline and after 30 days of treatment
Change from Baseline Strength Test at 1 month	Measurement of strength performed with the dominant hand using a hand-held dynamometer (Good Strength, IGS01, Metitur Oy, Jyväskylä, Finland) with the participant in the seated position with elbow flexed at 110°. The participant will be instructed to squeeze the handle as hard as possible for 3-5 seconds and the stregth will be recorded in kg	At baseline and after 30 days of treatment

Collaborators and Investigators

• Sponsor: Lo.Li.Pharma s.r.l

Publications and helpful links

General Publications

• Nordio M, Kumanov P, Chiefari A, Puliani G. D-Chiro-Inositol improves testosterone levels in older hypogonadal men with low-normal testosterone: a pilot study. Basic Clin Androl. 2021 Nov 12;31(1):28. doi: 10.1186/s12610-021-00146-4.

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2021
• Primary Completion (Actual): February 24, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 12, 2021
• First Posted (Actual): January 13, 2021

Study Record Updates

• Last Update Posted (Actual): March 2, 2021
• Last Update Submitted That Met QC Criteria: March 1, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Aromatase; Testosterone; Sexual dysfunction; Male Hypogonadism; D-chiroinositol
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Hypogonadism; Physiological Effects of Drugs; Micronutrients; Vitamins; Vitamin B Complex; Inositol
• Other Study ID Numbers: DCI_HYPOGONADAL_MALES

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No