Cholesterol, ElevatedNCT06657456
Impact of Phytosterol-Rich Extract on Lipid Profile
A study testing Phytosterol-rich extract in people with Cholesterol, Elevated and Hypercholesterolaemia, run by Desirée Victoria Montesinos at 1 site in Spain.
Trial summary
The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholesterol, Elevated, Hypercholesterolaemia, Lipid Metabolism Disorders
- What is being tested?
- Phytosterol-rich extract
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 42 participants
- Where
- 1 siteSpain
- Study dates
- 8 Jan 2025to 30 May 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults (age > 18 YO)
- Total cholesterol levels at screening ≥ 200 mg/dL
Who cannot join
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Use of prescribed medication which may interfere with study measurements.
- Unwillingness or inability to comply with clinical trial procedures.
- Subjects whose condition makes them ineligible for the study at the investigator's discretion.
- Pregnant or having the wish to become pregnant, or lactating.
- Recent participation in another nutritional or medical trial
Trial locations and contacts
1 site in 1 country.
Spain1 site
UCAM San Antonio Catholic University of Murcia
Murcia, Murcia, 30107
About this study
Official title: Nutritional Intervention Study of the Effect of a Phytosterol-rich Extract on Lipid Profile.
The aim of this randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.
Read the detailed description
The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
- Being tested
- Phytosterol-rich extract, Placebo
- Keywords
- Cholesterol, Cholesterol, Elevated, Hypercholesterolaemia, Lipid Metabolism Disorders, Dyslipidemias
- Medical subject headings
- Hypercholesterolemia, Lipid Metabolism Disorders, Dyslipidemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phytosterol-rich extractDietary supplement
Experimental product: extract rich in phytosterols
PlaceboDietary supplement
Product with identical characteristics to the experimental product.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Consumption of dietary supplement capsules for 56 days. Receives: Dietary Supplement: Phytosterol-rich extract |
| Control Group | Placebo comparator | Identically appearing placebo capsules consumed for 56 days. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood lipid profile
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
Measured: Day 1, at 28 and 56 days
Secondary outcomes (8)
Anthropometric parameters
Body weight (Kg), body mass index (kg/m^2) and waist circumference (cm)
Measured: Day 1, at 28 and 56 days
Body composition measures
Fat-free mass (Kg) and fat mass (Kg)
Measured: Day 1, at 28 and 56 days
Oxidation markers
Measurement of oxidized LDL
Measured: Day 1, at 28 and 56 days
Dietary Intake
Registration and subsequent nutritional evaluation with 3-day food frequency questionnaire (FFQ).
Measured: Day 1, at 28 and 56 days
Adherence to the Mediterranean diet
Measurement of adherence to the Mediterranean diet by the MEDAS questionnaire.
Measured: Day 1, at 28, and 56 days
Blood pressure
Systolic blood pressure and diastolic blood pressure (mmHg).
Measured: Day 1, at 28 and 56 days
Physical Activity
Measured by IPAQ/GPAQ questionnaire.
Measured: Day 1, at 28 and 56 days
Liver safety variables
It is a blood test that measures liver enzymes, such as GPT (ALT) and GOT (AST), to evaluate liver function.
Measured: Day 1, at 28 and 56 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2024
- Study start8 Jan 2025
- Primary completion10 Apr 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cholesterol, ElevatedStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Desirée Victoria Montesinos
- Sponsor type
- University, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Responsible party
- Sponsor-investigator, Desirée Victoria Montesinos, Universidad Católica San Antonio de Murcia
- Investigators
- Desirée Victoria Montesinos, Principal investigator, Universidad Católica San Antonio de MurciaAna Mª García Muñoz, Principal investigator, Universidad Católica San Antonio de Murcia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06657456
- Sponsor's protocol ID
- CE102401
- Status last verified
- Apr 2026
- First submitted
- 19 Oct 2024
- Last updated
- 4 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. 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 Lipid Profile.
- ClinicalTrials.gov ID
- NCT06657456
- Acronym / sponsor ID
- CE102401
- Keywords
- Cholesterol, Cholesterol, Elevated, Hypercholesterolaemia, Lipid Metabolism Disorders, Dyslipidemias
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Desirée Victoria MontesinosUniversity, hospital or other
- Collaborators
- Universidad Católica San Antonio de Murcia
- Study start
- 8 Jan 2025 (actual)
- Primary completion
- 10 Apr 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 24 Oct 2024 (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 randomized, parallel, two-arm, placebo-controlled, triple-blind clinical trial is to evaluate the efficacy of a phytosterol- and phytostanol-rich extract on lipid profile parameters in individuals with hypercholesterolemia, focusing primarily on total cholesterol and LDL cholesterol levels.
Detailed description
The duration of the study will be 56 days during which the investigational product or placebo will be consumed according to the assignment.
Subjects will be randomized to each of the study arms (consumption of the experimental product or control product).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Dietary Supplement: Phytosterol-rich extractConsumption of dietary supplement capsules for 56 days. |
| Control Group | Placebo comparator | Dietary Supplement: PlaceboIdentically appearing placebo capsules consumed for 56 days. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults (age > 18 YO)
- Total cholesterol levels at screening ≥ 200 mg/dL
Key exclusion criteria (6 listed)
- History of allergic hypersensitivity or poor tolerance to any component of the products under study.
- Use of prescribed medication which may interfere with study measurements.
- Unwillingness or inability to comply with clinical trial procedures.
- Subjects whose condition makes them ineligible for the study at the investigator's discretion.
- Pregnant or having the wish to become pregnant, or lactating.
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 |
|---|---|---|
| Phytosterol-rich extractExperimental product: extract rich in phytosterols | Dietary supplement | Experimental |
| PlaceboProduct with identical characteristics to the experimental product. | Dietary supplement | Control Group |
Primary outcome
Blood lipid profile
Time frame: Day 1, at 28 and 56 days
Includes total cholesterol, LDL-cholesterol, HDL-cholesterol and triglycerides
8 secondary outcomes
Anthropometric parameters
Time frame: Day 1, at 28 and 56 days
Body composition measures
Time frame: Day 1, at 28 and 56 days
Oxidation markers
Time frame: Day 1, at 28 and 56 days
Dietary Intake
Time frame: Day 1, at 28 and 56 days
Adherence to the Mediterranean diet
Time frame: Day 1, at 28, and 56 days
Blood pressure
Time frame: Day 1, at 28 and 56 days
Physical Activity
Time frame: Day 1, at 28 and 56 days
Liver safety variables
Time frame: Day 1, 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 4 May 2026.
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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.
Desirée Victoria Montesinos principal investigator
Universidad Católica San Antonio de Murcia
Ana Mª García Muñoz principal investigator
Universidad Católica San Antonio de Murcia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Phytosterol-rich extract in people with Cholesterol, Elevated and Hypercholesterolaemia, run by Desirée Victoria Montesinos at 1 site 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 2 inclusion and 6 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 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Blood lipid profile (time frame: Day 1, at 28 and 56 days). 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 4 May 2026.