Cholesterol LoweringHypolypoxNCT06954649
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
A study testing Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol. in people with Cholesterol Lowering and LDL Level, run by Centro de Edafología y Biología Aplicada del Segura at 2 sites in Spain.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cholesterol Lowering, LDL Level
- What is being tested?
- Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- 2 sitesSpain
- Study dates
- 14 Jan 2025to 27 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- -
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Centro de Edafología y Biología Aplicada del Segura (CEBAS-CSIC)
Murcia, 30100
Universidad Católica San Antonio de Murcia (UCAM)
Murcia, 30107
About this study
Official title: 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
Read the 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.
- Conditions
- Cholesterol Lowering, LDL Level
- Being tested
- Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol., Placebo
- Keywords
- cholesterol, LDL, HDL, oxidized LDL, triglycerides, phytosterols, bioactive compounds, resveratrol, hydroxytosol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
PlaceboOther
Individuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol. |
| 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. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total cholesterol
Change from baseline in total cholesterol levels measured at 28 and 56 days
Measured: 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
Measured: 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
Measured: From enrollment to the end of treatment at 56 days
Triglyceride
Change from baseline in triglyceride levels measured at 28 days and 56 days
Measured: From enrollment to the end of treatment at 56 days
Transaminase
Change from baseline in transaminase levels measured at 28 days and 56 days
Measured: 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
Measured: From enrollment to the end of treatment at 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2025
- Study start14 Jan 2025
- Primary completion24 Feb 2025
- Study completion27 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol LoweringStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centro de Edafología y Biología Aplicada del Segura
- Sponsor type
- Other government
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Principal investigator, Francisco A. Tomás-Barberán, Centro de Edafología y Biología Aplicada del Segura
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06954649
- Sponsor's protocol ID
- CE102401
- Other IDs
- SNEO-20231059
- Acronym
- Hypolypox
- Status last verified
- Apr 2025
- First submitted
- 24 Apr 2025
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on the Lipid Profile
- ClinicalTrials.gov ID
- NCT06954649
- Acronym / sponsor ID
- Hypolypox / CE102401
- Conditions
- Cholesterol Lowering, LDL Level
- Keywords
- cholesterol, LDL, HDL, oxidized LDL, triglycerides, phytosterols, bioactive compounds, resveratrol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Centro de Edafología y Biología Aplicada del SeguraOther government
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- 14 Jan 2025 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 27 Mar 2025 (actual)
- First posted
- 1 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Dietary Supplement: Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol.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. |
| Placebo group | Placebo comparator | Other: PlaceboControl group. They will take a placebo supplement. They will take two capsules of the placebo, in the evening after dinner. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Dietary supplement | Treatment group |
| PlaceboIndividuals will take two capsules daily of the placebo capsule for 56 days. Two capsules will be taken daily in the evening, after dinner | Other | Placebo group |
Primary outcome
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2025.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Plant based extract rich in phytosterols and phytostanols resveratrol and hydroxytyrosol. in people with Cholesterol Lowering and LDL Level, run by Centro de Edafología y Biología Aplicada del Segura at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total cholesterol (time frame: From enrollment to the end of treatment at 56 days). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2025; AzTrials last refreshed its copy on 7 Nov 2026.