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| ID | Type | Description | Link |
|---|---|---|---|
| SNEO-20231059 | Other Grant/Funding Number | Ministry of Science, Innovation and Universities. Government of Spain |
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| Name | Class |
|---|---|
| Universidad Católica San Antonio de Murcia | OTHER |
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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 EdafologÃa y BiologÃa 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment group | Experimental | 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. |
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| Placebo group | Placebo Comparator | Control group. They will take a placebo supplement. They will take two capsules of the placebo, in the evening after dinner. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol. | Dietary Supplement | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Total cholesterol | 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 | 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 | Change from baseline in cholesterol HDL levels measured at 28 and 56 days | From enrollment to the end of treatment at 56 days |
| Triglyceride | Change from baseline in triglyceride levels measured at 28 days and 56 days | From enrollment to the end of treatment at 56 days |
| Transaminase | 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 | Change from baseline in oxidized LDL levels measured at 28 and 56 days | From enrollment to the end of treatment at 56 days |
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Inclusion Criteria: total cholesterol>=200 mg/dl -
Exclusion Criteria: total cholesterol<200 mg/dl
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de EdafologÃa y BiologÃa Aplicada del Segura (CEBAS-CSIC) | Murcia | 30100 | Spain | |||
| Universidad Católica San Antonio de Murcia (UCAM) |
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Clinical trial organizer (Universidad Católica San Antonio de Murcia, UCAM)
| Placebo | Other | Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner |
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| Murcia |
| 30107 |
| Spain |
| ID | Term |
|---|---|
| D010840 | Phytosterols |
| C005975 | 3,4-dihydroxyphenylethanol |
| ID | Term |
|---|---|
| D013261 | Sterols |
| D002776 | Cholestanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D064209 | Phytochemicals |
| D001685 | Biological Factors |
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