Anti-eryptotic Effect of a Food Supplement with Plants Sterols in Hypercholesterolemia Treated with Statins
- Conditions
- AtherosclerosisCardiovascular DiseasesHypercholesterolemia
- Interventions
- Dietary Supplement: PS-containing dietary supplementOther: Placebo
- Registration Number
- NCT05901246
- Lead Sponsor
- University of Valencia
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 26
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PS-containing dietary supplement PS-containing dietary supplement Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day) Placebo Placebo Sachet containing the excipients of the ingredient (2,25 g placebo/day)
- Primary Outcome Measures
Name Time Method Changes in the externalization of phosphatidylserine 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 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 Outcome Measures
Name Time Method Changes in cell size ('forward scatter') 0 and 6 weeks Cell size, assessed by flow cytometry with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic High-sensitivity C-reactive protein (hsCRP) 0 and 6 weeks hs CRP, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic levels of cholesterol oxidation products (COPs) 0 and 6 weeks COPs levels, assessed by gas chromatography-mass spectometry, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic HDL-c 0 and 6 weeks HDL-c, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Evaluation of the mediterranean diet adherence to measure quality of life 0 weeks Mediterranean diet adherence screener (MEDAS) is used, consisting in 14 questions (each one 0 or 1 point, final score between 0 and 14). Results are ranged between 0-7 points (low adherence), 7-10 (moderate adherence), and 10-14 (high adherence). This is only evaluated at the beginning of the intervention.
Changes in reduced glutathione cellular levels (GSH) 0 and 6 weeks GSH, assessed by flow cytometry (Green CMFDA), with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic LDL-c 0 and 6 weeks LDL-c, calculated by the Friedewald's formula, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic Apo A 0 and 6 weeks Apo A, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR) 0 and 6 weeks HOMA-IR, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic glucose 0 and 6 weeks Glucose, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic Apo B 0 and 6 weeks Apo B, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic total cholesterol 0 and 6 weeks Total cholesterol, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic triglycerides 0 and 6 weeks Triglycerides, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Changes in plasmatic insulin 0 and 6 weeks Insulin, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Evaluation of the physical activity to measure quality of life 0 weeks International physical activity questionaire-short form (IPAC-SF) is used, consisting in 7 questions. Intensity, frequency and duration of the exercise are evaluated through metabolic equivalent of task (METs). This allows to differentiate 3 levels of physical activity:
Low: Not enough activity to achieve the next level
Moderate: 3 or more days of vigorous physical activity for at least 20 minutes per day, 5 or more days of moderate physical activity and/or walking at least 30 minutes per day, or 5 or more days of any combination of walking, moderate or vigorous physical activity achieving at least a total of 600 METs
High: Vigorous physical activity at least 3 days per week achieving a total of at least 1500 METs, or 7 days of any combination of walking, with moderate and/or vigorous physical activity, achieving a total of at least 3000 METs
This is only evaluated at the beginning of the intervention.
Trial Locations
- Locations (1)
Hospital Clínico Universitario de Valencia
🇪🇸Valencia, Spain