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

NCT05901246 | Completed

• 2 other identifiers: BIONUTEST_2023/069PID2019-104167RB-I00
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis

Keywords

Cholesterol; Plant Sterols; Eryptosis; Cholesterol oxidation products

Outcome Measures

Primary Outcomes (2)

• Changes in the externalization of phosphatidylserine

  The externalization of phosphatidylserine, assessed by flow cytometry (Kit Annexin V) with repeated measures (at the beginning and at the end of the intervention)

  0 and 6 weeks

• Changes in the adhesion to the endothelium by eryptotic erythrocytes

  The adhesion to the endothelium by eryptotic erythrocytes, assessed with parallel-plate flow chamber technique in human umbilical vein endothelial cells (HUVECs) with repeated measures (at the beginning and at the end of the intervention)

  0 and 6 weeks

Secondary Outcomes (15)

• Changes in cell size ('forward scatter')

  0 and 6 weeks

• Changes in reduced glutathione cellular levels (GSH)

  0 and 6 weeks

• Changes in plasmatic levels of cholesterol oxidation products (COPs)

  0 and 6 weeks

• Changes in plasmatic glucose

  0 and 6 weeks

• Changes in plasmatic total cholesterol

  0 and 6 weeks

Study Arms (2)

PS-containing dietary supplement

EXPERIMENTAL

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

Dietary Supplement: PS-containing dietary supplement

Placebo

PLACEBO COMPARATOR

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

Other: Placebo

Interventions

PS-containing dietary supplement DIETARY_SUPPLEMENT

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

PS-containing dietary supplement

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Valencia: lead
• Hospital Clínico Universitario de Valencia: collaborator
• University of Bologna: collaborator

Study Sites (1)

Hospital Clínico Universitario de Valencia

Valencia, Valencia, 46010, Spain

Location

Related Publications (2)

• 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.

  PMID: 34473881 BACKGROUND

• 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.

  PMID: 35328440 BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypercholesterolemia; Atherosclerosis

Condition Hierarchy (Ancestors)

Hyperlipidemias; Dyslipidemias; Lipid Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Amparo Asunción Alegría Torán, Professor

  University of Valencia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: June 13, 2023
• Study Start: October 19, 2023
• Primary Completion: November 29, 2024
• Study Completion: November 29, 2024
• Last Updated: December 16, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)