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

University of Valencia

Status: Completed

Conditions: Hypercholesterolemia; Cardiovascular Diseases; Atherosclerosis

Treatments: Other: Placebo; Dietary Supplement: PS-containing dietary supplement

Study type: Interventional

Funder types: Other

Identifiers

NCT05901246

PID2019-104167RB-I00 (Other Grant/Funding Number)

BIONUTEST_2023/069

Details and patient eligibility

About

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.

Full 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).

Enrollment: 26 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants with hypercholesterolemia (LDL cholesterol ≥ 160mg/dl at the time of diagnosis), receiving treatment with moderate intensity statins (atorvastatin 10-20 mg or simvastatin 20-40 mg or rosuvastatin 5-10 mg)
• No previous episodes of cardiovascular disease
• Absence of other analytical abnormalities or previous illnesses

Exclusion criteria

• Diabetes mellitus
• Participants in secondary prevention
• Treatment with lipid-lowering drugs other than atorvastatin, simvastatin or rosuvastatin
• Liver disease
• Renal failure
• Uncontrolled hypothyroidism
• Smokers
• Participants consuming foods enriched with PS or food supplements that contain PS

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 2 patient groups, including a placebo group

PS-containing dietary supplement

Experimental group

Description:

Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)

Treatment:

Dietary Supplement: PS-containing dietary supplement

Placebo

Placebo Comparator group

Description:

Sachet containing the excipients of the ingredient (2,25 g placebo/day)

Treatment:

Other: Placebo