Evaluation of the Functionality of an Extract Rich in Phytosterols and Phytostanols on Parameters Related to the Lipid Profile of Individuals With Hypercholesterolemia, Mainly in the Levels of Total Cholesterol, LDL Cholesterol and Oxidized LDL
NCT ID: NCT06954649
Last Updated: 2025-05-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
45 participants
INTERVENTIONAL
2025-01-14
2025-03-27
Brief Summary
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Detailed Description
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First, participants will attend to an informative session to learn in more detail about the objectives of the study and the procedures to be followed. In this session participants will sign the informed consent.
They will be divided into two groups:
* One group (n=23) that will take an extract rich in phytosterols and phytostanols (mainly β-sitosterol, β-sitostanol, campesterol and stigmasterol), resveratrol and hydroxytyrosol. The extract will be taken in capsule format.
* A control group (n=22) that will take a placebo supplement.
At the beginning of the study, anthropometric measurements of the participants will be taken. The participants' blood pressure will also be measured. An interview-questionnaire will be conducted to learn about and evaluate participants´s diet, physical activity and sleep quality. A blood sample will also be taken from the participants for biochemical analysis (total cholesterol, HDL, LDL, oxidized LDL, triglycerides and transaminases). From this day on, all participants will take two capsules daily of the phytosterol-rich extract or the placebo capsule, as appropriate, for 56 days. Capsules will be taken at night after dinner. Sampling and biochemical analysis will be repeated on days 28 and 56.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Treatment group
Experimental group. They will take an extract rich in phytosterols and phytostanols, resveratrol and hydroxytyrosol. They will take two capsules of the extract in the evening after dinner.
Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.
Individuals will take two capsules daily of the phytosterol-rich extract for 56 days. Two capsules will be taken daily in the evening, after dinner
Placebo group
Control group. They will take a placebo supplement. They will take two capsules of the placebo, in the evening after dinner.
Placebo
Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner
Interventions
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Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.
Individuals will take two capsules daily of the phytosterol-rich extract for 56 days. Two capsules will be taken daily in the evening, after dinner
Placebo
Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner
Eligibility Criteria
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Exclusion Criteria
ALL
No
Sponsors
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Universidad Católica San Antonio de Murcia
OTHER
Centro de Edafología y Biología Aplicada del Segura
OTHER_GOV
Responsible Party
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Francisco A. Tomás-Barberán
Research Professor
Locations
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Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)
Murcia, , Spain
Universidad Católica San Antonio de Murcia (UCAM)
Murcia, , Spain
Countries
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Other Identifiers
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SNEO-20231059
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
CE102401
Identifier Type: -
Identifier Source: org_study_id
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