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Completed

NCT Number: NCT05901246

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

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.

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Key information

Conditions

Cardiovascular Diseases Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Dyslipidemias Hypercholesterolemia Hyperlipidemias Lipid Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Vascular Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Clínico Universitario de Valencia

Valencia, 46010, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PS-containing dietary supplement

Dietary Supplement

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

Placebo

Other

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

Primary outcomes

  1. 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)

  2. 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

  1. Changes in cell size ('forward scatter')

    Time frame: 0 and 6 weeks

    Cell size, assessed by flow cytometry with repeated measures (at the beginning and at the end of the intervention)

  2. Changes in reduced glutathione cellular levels (GSH)

    Time frame: 0 and 6 weeks

    GSH, assessed by flow cytometry (Green CMFDA), with repeated measures (at the beginning and at the end of the intervention)

  3. Changes in plasmatic levels of cholesterol oxidation products (COPs)

    Time frame: 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)

  4. Changes in plasmatic glucose

    Time frame: 0 and 6 weeks

    Glucose, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  5. Changes in plasmatic total cholesterol

    Time frame: 0 and 6 weeks

    Total cholesterol, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  6. Changes in plasmatic HDL-c

    Time frame: 0 and 6 weeks

    HDL-c, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  7. Changes in plasmatic LDL-c

    Time frame: 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)

  8. Changes in plasmatic triglycerides

    Time frame: 0 and 6 weeks

    Triglycerides, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  9. Changes in plasmatic Apo A

    Time frame: 0 and 6 weeks

    Apo A, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  10. Changes in plasmatic Apo B

    Time frame: 0 and 6 weeks

    Apo B, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  11. Changes in plasmatic High-sensitivity C-reactive protein (hsCRP)

    Time frame: 0 and 6 weeks

    hs CRP, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  12. Changes in plasmatic insulin

    Time frame: 0 and 6 weeks

    Insulin, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  13. Changes in plasmatic Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)

    Time frame: 0 and 6 weeks

    HOMA-IR, assessed by enzymatic-colorimetric methods, with repeated measures (at the beginning and at the end of the intervention)

  14. Evaluation of the mediterranean diet adherence to measure quality of life

    Time frame: 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.

  15. Evaluation of the physical activity to measure quality of life

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Valencia

Other

Collaborators

  • Hospital Clínico Universitario de Valencia
  • University of Bologna

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Jun 13, 2023
Registry last updated
Dec 16, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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