Clinical trial NCT06954649: 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
Official title: Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on the Lipid Profile
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cholesterol Lowering
LDL Level
Keywords: cholesterol
LDL
HDL
oxidized LDL
triglycerides
phytosterols
bioactive compounds
resveratrol
hydroxytosol
Lead sponsor: Centro de Edafología y Biología Aplicada del Segura
Sponsor class: OTHER_GOV
Collaborators: name: Universidad Católica San Antonio de Murcia
First posted: 2025-05-01
Enrollment: 45
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The aim of this clinical trial is to evaluate the functionality of an extract rich in phytosterols and phytostanols on parameters related to the lipid profile of individuals with hypercholesterolemia, mainly on total cholesterol and LDL cholesterol levels

Detailed description: A total of 45 participants with hypercholesterolemia (total cholesterol\>200 mg/dL) will be recruited. Participants must not be taking any medication or nutritional supplement aimed at lowering cholesterol levels. Social networks and advertisements at the Universidad Católica San Antonio de Murcia (UCAM) and the Centro de Edafología y Biología Aplicada del Segura (CEBAS) will be used to recruit the individuals.

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.

Eligibility criteria: Inclusion Criteria: total cholesterol\>=200 mg/dl -

Exclusion Criteria: total cholesterol\<200 mg/dl

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Primary outcomes:
measure: Total cholesterol
timeFrame: From enrollment to the end of treatment at 56 days
measure: Cholesterol LDL
timeFrame: From enrollment to the end of treatment at 56 days
measure: Cholesterol HDL
timeFrame: From enrollment to the end of treatment at 56 days
measure: Triglyceride
timeFrame: From enrollment to the end of treatment at 56 days
measure: Transaminase
timeFrame: From enrollment to the end of treatment at 56 days
measure: Oxidized LDL
timeFrame: From enrollment to the end of treatment at 56 days
Secondary outcomes:
Other outcomes:
Locations:
city: Murcia
country: Spain
facility: Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)
city: Murcia
country: Spain
facility: Universidad Católica San Antonio de Murcia (UCAM)
Study officials:
References: