Cholesterol Lowering, LDL Level
Conditions
Keywords
cholesterol, LDL, HDL, oxidized LDL, triglycerides, phytosterols, bioactive compounds, resveratrol, hydroxytosol
Brief 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.
Interventions
DIETARY_SUPPLEMENTPlant 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
OTHERPlacebo
Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner
Sponsors
Universidad Católica San Antonio de Murcia
Centro de Edafología y Biología Aplicada del Segura
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Clinical trial organizer (Universidad Católica San Antonio de Murcia, UCAM)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
total cholesterol\>=200 mg/dl -
Exclusion criteria
total cholesterol\<200 mg/dl \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total cholesterol | From enrollment to the end of treatment at 56 days | Change from baseline in total cholesterol levels measured at 28 and 56 days |
| Cholesterol LDL | From enrollment to the end of treatment at 56 days | Change from baseline in cholesterol LDL levels measured at 28 and 56 days |
| Cholesterol HDL | From enrollment to the end of treatment at 56 days | Change from baseline in cholesterol HDL levels measured at 28 and 56 days |
| Triglyceride | From enrollment to the end of treatment at 56 days | Change from baseline in triglyceride levels measured at 28 days and 56 days |
| Transaminase | From enrollment to the end of treatment at 56 days | Change from baseline in transaminase levels measured at 28 days and 56 days |
| Oxidized LDL | From enrollment to the end of treatment at 56 days | Change from baseline in oxidized LDL levels measured at 28 and 56 days |
Countries
Spain
Outcome results
None listed