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Cardiovascular DiseasesNCT05901246

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

A study testing PS-containing dietary supplement in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Valencia at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
PS-containing dietary supplement
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
26 participants
Where
1 siteSpain
Study dates
19 Oct 2023to 29 Nov 2024
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Spain1 site

  • Hospital Clínico Universitario de Valencia

    Valencia, Valencia, 46010

Other trials in Spain

About this study

Official title: Anti-eryptotic Effect of Regular Intake of a Food Supplement with Plants Sterols in Subjects with 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.

Read the 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).

Being tested
PS-containing dietary supplement, Placebo
Keywords
Cholesterol, Plant Sterols, Eryptosis, Cholesterol oxidation products
Medical subject headings
Cardiovascular Diseases, Hypercholesterolemia, Atherosclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PS-containing dietary supplementDietary supplement

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

  • PlaceboOther

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

Study groups in NCT05901246
Study groupRoleWhat they receive
PS-containing dietary supplementExperimentalSachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
Receives: Dietary Supplement: PS-containing dietary supplement
PlaceboPlacebo comparatorSachet containing the excipients of the ingredient (2,25 g placebo/day)
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 0 and 6 weeks

  2. 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)

    Measured: 0 and 6 weeks

Secondary outcomes (15)

  1. 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)

    Measured: 0 and 6 weeks

  2. 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)

    Measured: 0 and 6 weeks

  3. 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)

    Measured: 0 and 6 weeks

  4. Changes in plasmatic glucose

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

    Measured: 0 and 6 weeks

  5. 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)

    Measured: 0 and 6 weeks

  6. 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)

    Measured: 0 and 6 weeks

  7. 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)

    Measured: 0 and 6 weeks

  8. Changes in plasmatic triglycerides

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

    Measured: 0 and 6 weeks

  9. 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)

    Measured: 0 and 6 weeks

  10. 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)

    Measured: 0 and 6 weeks

  11. 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)

    Measured: 0 and 6 weeks

  12. Changes in plasmatic insulin

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

    Measured: 0 and 6 weeks

  13. 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)

    Measured: 0 and 6 weeks

  14. 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.

    Measured: 0 weeks

  15. 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.

    Measured: 0 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Jun 2023
  2. Study start19 Oct 2023
  3. Primary completion29 Nov 2024
  4. Study completion29 Nov 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
26 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05901246
Sponsor's protocol ID
BIONUTEST_2023/069
Other IDs
PID2019-104167RB-I00
Status last verified
Jun 2024
First submitted
8 May 2023
Last updated
16 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 34473881

  • 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.

    PubMed 35328440

  • Miedes D, Mercatante D, Broseta S, Cilla A, Rodriguez-Estrada MT, Alegria A. Effect of Plant Sterols on Cholesterol Oxidation Products in Statin-Treated Hypercholesterolemic Individuals: A Pilot Study. J Diet Suppl. 2026 Jun 29:1-16. doi: 10.1080/19390211.2026.2695120. Online ahead of print.

    PubMed 42374719

Questions about this trial

What is this clinical trial studying?

A study testing PS-containing dietary supplement in people with Cardiovascular Diseases and Hypercholesterolemia, run by University of Valencia at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the externalization of phosphatidylserine (time frame: 0 and 6 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05901246, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2024.

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