An interventional study of Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol. and Placebo in Cholesterol Lowering and LDL Level, sponsored by Centro de Edafología y Biología Aplicada del Segura. Completed at 2 sites in Spain. Per ClinicalTrials.gov, last updated 2025-05-01.
Sponsored by Centro de Edafología y Biología Aplicada del Segura · Not applicable, Interventional, and Treatment
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
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:
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.
Centro de Edafología y Biología Aplicada del Segura is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria: total cholesterol>=200 mg/dl -
Exclusion Criteria: total cholesterol\<200 mg/dl
-
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.
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 phytosterol-rich extract for 56 days. Two capsules will be taken daily in the evening, after dinner
Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner
Total cholesterol
Change from baseline in total cholesterol levels measured at 28 and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Cholesterol LDL
Change from baseline in cholesterol LDL levels measured at 28 and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Cholesterol HDL
Change from baseline in cholesterol HDL levels measured at 28 and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Triglyceride
Change from baseline in triglyceride levels measured at 28 days and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Transaminase
Change from baseline in transaminase levels measured at 28 days and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Oxidized LDL
Change from baseline in oxidized LDL levels measured at 28 and 56 days
Time frame: From enrollment to the end of treatment at 56 days
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Centro de Edafología y Biología Aplicada del Segura