An interventional study of PS-containing dietary supplement and Placebo in Cardiovascular Diseases, Hypercholesterolemia and Atherosclerosis, sponsored by University of Valencia. Completed at 1 site in Spain. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2024-12-16.
Sponsored by University of Valencia · Not applicable, Interventional, and Basic science
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.
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).
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This study's enrollment of 26 is below the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
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Exclusion Criteria:
Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
Dietary Supplement: PS-containing dietary supplement
Sachet containing the excipients of the ingredient (2,25 g placebo/day)
Other: Placebo
Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
Sachet containing the excipients of the ingredient (2,25 g placebo/day)
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)
Time frame: 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)
Time frame: 0 and 6 weeks
Changes in cell size ('forward scatter')
Cell size, assessed by flow cytometry with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in reduced glutathione cellular levels (GSH)
GSH, assessed by flow cytometry (Green CMFDA), with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic levels of cholesterol oxidation products (COPs)
COPs levels, assessed by gas chromatography-mass spectometry, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic glucose
Glucose, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic total cholesterol
Total cholesterol, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic HDL-c
HDL-c, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic LDL-c
LDL-c, calculated by the Friedewald's formula, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic triglycerides
Triglycerides, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic Apo A
Apo A, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic Apo B
Apo B, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic High-sensitivity C-reactive protein (hsCRP)
hs CRP, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic insulin
Insulin, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
HOMA-IR, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)
Time frame: 0 and 6 weeks
Evaluation of the mediterranean diet adherence to measure quality of life
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.
Time frame: 0 weeks
Evaluation of the physical activity to measure quality of life
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.
Time frame: 0 weeks
Plan to share: No
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University of Valencia