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Anti-eryptotic Effect of a Food Supplement With Plants Sterols in Hypercholesterolemia Treated With Statins

Cardiovascular Diseases Clinical Trial

Official title:
Anti-eryptotic Effect of Regular Intake of a Food Supplement With Plants Sterols in Subjects With Hypercholesterolemia Treated With Statins

Clinical Trial Summary

Potential anti-eryptotic effect of a regular intake of a plant sterol (PS)-containing food supplement, in moderate hypercholesterolemic patients treated with the PS-containing food supplement or placebo supplement.

Clinical Trial Description

Oxidative damage has been related to the externalization of phosphatidylserine in erythrocytes, an event associated with eryptosis (programmed death of erythrocytes). In addition, an increase in eryptosis has been observed in patients with hypercholesterolaemia. PS-enriched food supplements could be a nutritional strategy to improve risk factors in patients with moderate hypercholesterolemia treated with statins, constituting a synergistic treatment with these drugs. The present study aims to evaluate the eryptotic process (externalization of phosphatidylserine) after regular intake of a food supplement containing PS (2g/day) in patients with moderate hypercholesterolemia treated with statins. This is a case-control study with 32 cases (intake or a PS-containing food supplement) and 16 controls (placebo intake based on the excipient), with an intervention period of 6 weeks. The evaluation of eryptosis is carried out by determining the externalization of phosphatidylserine, the size of the erythrocytes and an ex vivo assay of adhesion of eryptotic erythrocytes to the vascular endothelium. In addition, the redox state (GSH), the in vivo oxidation of cholesterol (COPs), and biochemical and hematological parameters are evaluated. All parameters are evaluated at the beginning (week 0) and at the end of the intervention period (week 6). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05901246
Study type Interventional
Source University of Valencia
Contact
Status Active, not recruiting
Phase N/A
Start date October 19, 2023
Completion date October 2024
View Details
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