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 (Hypolypox)

Centro de Edafología y Biología Aplicada del Segura

Status: Completed

Conditions: Cholesterol Lowering; LDL Level

Treatments: Dietary Supplement: Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT06954649

SNEO-20231059 (Other Grant/Funding Number)

CE102401

Details and patient eligibility

About

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

Full 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.

Enrollment: 45 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Exclusion Criteria: total cholesterol<200 mg/dl

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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45 participants in 2 patient groups, including a placebo group

Treatment group

Experimental group

Description:

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.

Treatment:

Dietary Supplement: Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.

Placebo group

Placebo Comparator group

Description:

Control group. They will take a placebo supplement. They will take two capsules of the placebo, in the evening after dinner.

Treatment:

Other: Placebo