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

Sponsor

Lo.Li.Pharma s.r.l (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05689710

Collaborator

(none)

Enrollment

Location

Arms

8.3

Anticipated Duration (Months)

3.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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

Condition or Disease	Intervention/Treatment	Phase
Metabolic Syndrome Cardiac Fibrosis	Dietary Supplement: Inositol and alpha-lactalbumin	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Supportive Care

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

Actual Study Start Date :

Dec 23, 2022

Anticipated Primary Completion Date :

Jul 1, 2023

Anticipated Study Completion Date :

Sep 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: No intervention
Experimental: Experimental Dietary Supplement with inositols and alpha-lactalbumin	Dietary Supplement: Inositol and alpha-lactalbumin The administration of an oral formulation based on inositol and alpha-lactalbumin (two sachets/day for 180 days)

Arm

Intervention/Treatment

No Intervention: No intervention

Experimental: Experimental

Dietary Supplement with inositols and alpha-lactalbumin

Dietary Supplement: Inositol and alpha-lactalbumin

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

Outcome Measures

Primary Outcome Measures

Body weight [Four time points: changes in body weight (kg) from the baseline to 30, 90, 180 days]

Secondary Outcome Measures

Tryglicerides [Four time points: changes in blood levels of tryglycerides from the baseline to 30, 90, 180 days]
Plasmatic levels of tryglicerides
Hypertension [Four time points: changes in values of systolic and diastolic blood pressure from the baseline to 30, 90, 180 days]
sphygmomanometer

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UOC Medicina Interna e Nefrologia P.O. AQ	L'Aquila		Italy

Sponsors and Collaborators

Lo.Li.Pharma s.r.l

Investigators

Principal Investigator: Davide Grassi, MD, UOC Medicina Interna e Nefrologia P.O. AQ
Principal Investigator: Claudio Ferri, MD, UOC Medicina Interna e Nefrologia P.O. AQ

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Lo.Li.Pharma s.r.l

ClinicalTrials.gov Identifier:

NCT05689710

Other Study ID Numbers:

CARDIO_INO22

First Posted:

Jan 19, 2023

Last Update Posted:

Jan 20, 2023

Last Verified:

Jan 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 20, 2023