Anti-eryptotic Effect of Regular Intake of a Food Supplement with Plants Sterols in Subjects with Hypercholesterolemia Treated with Statins
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Valencia
- Enrollment
- 26
- Locations
- 1
- Primary Endpoint
- Changes in the externalization of phosphatidylserine
Study Overview
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.
Detailed 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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Basic Science
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- •Participants consuming foods enriched with PS or food supplements that contain PS
Arms & Interventions
PS-containing dietary supplement
Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
Intervention: PS-containing dietary supplement (Dietary Supplement)
Placebo
Sachet containing the excipients of the ingredient (2,25 g placebo/day)
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Changes in the externalization of phosphatidylserine
Time Frame: 0 and 6 weeks
The externalization of phosphatidylserine, assessed by flow cytometry (Kit Annexin V) with repeated measures (at the beginning and at the end of the intervention)
Changes in the adhesion to the endothelium by eryptotic erythrocytes
Time Frame: 0 and 6 weeks
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)
Secondary Outcomes
- Changes in cell size ('forward scatter')(0 and 6 weeks)
- Changes in plasmatic High-sensitivity C-reactive protein (hsCRP)(0 and 6 weeks)
- Changes in plasmatic levels of cholesterol oxidation products (COPs)(0 and 6 weeks)
- Changes in plasmatic HDL-c(0 and 6 weeks)
- Evaluation of the mediterranean diet adherence to measure quality of life(0 weeks)
- Changes in reduced glutathione cellular levels (GSH)(0 and 6 weeks)
- Changes in plasmatic LDL-c(0 and 6 weeks)
- Changes in plasmatic Apo A(0 and 6 weeks)
- Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)(0 and 6 weeks)
- Changes in plasmatic glucose(0 and 6 weeks)
- Changes in plasmatic Apo B(0 and 6 weeks)
- Changes in plasmatic total cholesterol(0 and 6 weeks)
- Changes in plasmatic triglycerides(0 and 6 weeks)
- Changes in plasmatic insulin(0 and 6 weeks)
- Evaluation of the physical activity to measure quality of life(0 weeks)
Investigators
Amparo Alegria
Principal investigator
University of Valencia