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)

April 24, 2025 updated by: Francisco A. Tomás-Barberán, Centro de Edafología y Biología Aplicada del Segura

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

45

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Murcia, Spain, 30100
        • Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)
      • Murcia, Spain, 30107
        • Universidad Católica San Antonio de Murcia (UCAM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Exclusion Criteria: total cholesterol<200 mg/dl

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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
Placebo Comparator: Placebo group
Control group. They will take a placebo supplement. They will take two capsules of the placebo, 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Total cholesterol
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in total cholesterol levels measured at 28 and 56 days
From enrollment to the end of treatment at 56 days
Cholesterol LDL
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in cholesterol LDL levels measured at 28 and 56 days
From enrollment to the end of treatment at 56 days
Cholesterol HDL
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in cholesterol HDL levels measured at 28 and 56 days
From enrollment to the end of treatment at 56 days
Triglyceride
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in triglyceride levels measured at 28 days and 56 days
From enrollment to the end of treatment at 56 days
Transaminase
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in transaminase levels measured at 28 days and 56 days
From enrollment to the end of treatment at 56 days
Oxidized LDL
Time Frame: From enrollment to the end of treatment at 56 days
Change from baseline in oxidized LDL levels measured at 28 and 56 days
From enrollment to the end of treatment at 56 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Centro de Edafología y Biología Aplicada del Segura

Collaborators

Universidad Católica San Antonio de Murcia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 14, 2025

Primary Completion (Actual)

February 24, 2025

Study Completion (Actual)

March 27, 2025

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 1, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 24, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CE102401
  • SNEO-20231059 (Other Grant/Funding Number: Ministry of Science, Innovation and Universities. Government of Spain)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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