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

Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on the Lipid Profile

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 45 (actual)
• Sponsor: Centro de Edafología y Biología Aplicada del Segura · Other Government
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cholesterol Lowering
• LDL Level

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	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
OTHER	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

Timeline

• Start date: 2025-01-14
• Primary completion: 2025-02-24
• Completion: 2025-03-27
• First posted: 2025-05-01
• Last updated: 2025-05-01

Locations

2 sites across 1 country: Spain