MedDataX Logo

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

NCT ID: NCT05901246

Last Updated: 2024-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-19

Study Completion Date

2024-11-29

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiovascular Diseases Hypercholesterolemia Atherosclerosis

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

Cholesterol Plant Sterols Eryptosis Cholesterol oxidation products

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

PS-containing dietary supplement

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

Group Type EXPERIMENTAL

PS-containing dietary supplement

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PS-containing dietary supplement

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Clínico Universitario de Valencia

OTHER

Sponsor Role collaborator

University of Bologna

OTHER

Sponsor Role collaborator

University of Valencia

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Amparo Alegria

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Amparo Asunción Alegría Torán, Professor

Role: PRINCIPAL_INVESTIGATOR

University of Valencia

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Hospital Clínico Universitario de Valencia

Valencia, Valencia, Spain

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Spain

References

Explore related publications, articles, or registry entries linked to this study.

Cilla A, Lopez-Garcia G, Collado-Diaz V, Amparo Blanch-Ruiz M, Garcia-Llatas G, Barbera R, Martinez-Cuesta MA, Real JT, Alvarez A, Martinez-Hervas S. Hypercholesterolemic patients have higher eryptosis and erythrocyte adhesion to human endothelium independently of statin therapy. Int J Clin Pract. 2021 Nov;75(11):e14771. doi: 10.1111/ijcp.14771. Epub 2021 Sep 7.

Reference Type BACKGROUND
PMID: 34473881 (View on PubMed)

Restivo I, Attanzio A, Tesoriere L, Allegra M, Garcia-Llatas G, Cilla A. Anti-Eryptotic Activity of Food-Derived Phytochemicals and Natural Compounds. Int J Mol Sci. 2022 Mar 11;23(6):3019. doi: 10.3390/ijms23063019.

Reference Type BACKGROUND
PMID: 35328440 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PID2019-104167RB-I00

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

BIONUTEST_2023/069

Identifier Type: -

Identifier Source: org_study_id