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NCT05689710 Clinical Trial

The Effects of Inositol on Glucose Metabolism in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

Metabolic Syndrome Clinical Trial

Official title:
The Action of Inositols and Alpha-lactalbumin on Glucose Metabolism, Arterial Stiffness and Vascular Damage in Patients With Metabolic Syndrome at Risk of Cardiac Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05689710
Other study ID # CARDIO_INO22
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 23, 2022
Est. completion date June 2024

Study information
Verified date January 2023
Source Lo.Li.Pharma s.r.l
Contact Davide Grassi, MD
Phone +393332123716
Email davide.grassi@cc.univaq.it
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study aims to evaluate the effects of an oral supplementation based on inositols and alpha-lactalbumin on principals metabolic parameters in patients with metabolic syndrome at risk of cardiac fibrosis

Recruitment information / eligibility
Status Recruiting
Enrollment 30
Est. completion date June 2024
Est. primary completion date December 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility At least 3 of the following inclusion criteria: - triglycerides levels = 150 mg/dL - HDL = 40 mg/dL - Fasting glycemia > 100 mg/dL <126 mg/dl - Systolic Pressure = 130 mmHg or Diastolic pressure = 85 mmHg - Hip circumference > 102 cm in men or 88 cm in women

Study Design

Related Conditions & MeSH terms

Intervention

Dietary Supplement:
• Inositol and alpha-lactalbumin
The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)

Locations
Country Name City State
Italy UOC Medicina Interna e Nefrologia P.O. AQ L'Aquila

Sponsors (1)
Lead Sponsor Collaborator
Lo.Li.Pharma s.r.l

Country where clinical trial is conducted

Italy, 

Outcome
Type Measure Description Time frame Safety issue
Primary Body weight Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days
Secondary Tryglicerides Plasmatic levels of tryglicerides Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days
Secondary Hypertension sphygmomanometer Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days
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