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
• Status: Recruiting
• Phase: N/A
• Start date: December 23, 2022
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Lo.Li.Pharma s.r.l
• Contact: Davide Grassi, MD
• Phone: +393332123716
• Email: davide.grassi[@]cc.univaq.it
• Is FDA regulated: No
• 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: January 2025
• Est. primary completion date: October 2024
• 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

Related Conditions & MeSH terms

• Cardiac Fibrosis
• Fibrosis
• Metabolic Syndrome
• Syndrome

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