- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05901246
Anti-eryptotic Effect of a Food Supplement With Plants Sterols in Hypercholesterolemia Treated With Statins
Anti-eryptotic Effect of Regular Intake of a Food Supplement With Plants Sterols in Subjects With Hypercholesterolemia Treated With Statins
Study Overview
Status
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Amparo Asunción Alegría Torán, Professor
- Phone Number: +34 963544907
- Email: amparo.alegria@uv.es
Study Locations
-
-
-
Valencia, Spain, 46010
- Recruiting
- Hospital Clínico Universitario de Valencia
-
Contact:
- Sergio Martínez Hervás
- Phone Number: 961625694
- Email: sergio.martinez@uv.es
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: PS-containing dietary supplement
Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
|
Sachet containing a powdered ingredient source of microencapsulated free plant sterols (2,25 g ingredient/day)
|
Placebo Comparator: Placebo
Sachet containing the excipients of the ingredient (2,25 g placebo/day)
|
Sachet containing the excipients of the ingredient (2,25 g placebo/day)
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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)
|
0 and 6 weeks
|
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.
|
0 weeks
|
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. |
0 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Amparo Asunción Alegría Torán, Professor, University of Valencia
Publications and helpful links
General 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIONUTEST_2023/069
- PID2019-104167RB-I00 (Other Grant/Funding Number: MCIN/AEI/10.13039/501100011033)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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