NCT Number: NCT06954649
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
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Interventional
Not applicable
Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC), Murcia, Spain
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
total cholesterol>=200 mg/dl -
Exclusion criteria
total cholesterol<200 mg/dl
-
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
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
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
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
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
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
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
Centro de Edafología y Biología Aplicada del Segura
Other Gov
Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on the Lipid Profile
Acronym: Hypolypox
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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