HyperlipoproteinemiaNCT07405814
Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels
A study testing investigational product containing phytosterol, artichoke extract and thiamin in people with Hyperlipoproteinemia, run by Zentiva, k.s. at 1 site in Poland.
Trial summary
The goal of this clinical trial is to learn if Artisterol works to lower LDL cholesterol and other metabolic and vascular risk factors in adults. The main questions it aims to answer are: Does Artisterol lower low-density lipoprotein cholesterol (LDL-C) levels in participants and by how much? Researchers will compare… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Hyperlipoproteinemia
- What is being tested?
- investigational product containing phytosterol, artichoke extract and thiamin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 1 sitePoland
- Study dates
- 24 Apr 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female or male, 18-70 years old.
- Subjects with mild hypercholesterolemia previously untreated (LDL-C levels between 115 and 160 mg/dL. Note that the upper limit can be extended to 190 mg/dL in case of subject refusing another treatment or intolerant to statins or other lipid lowering therapies. If previously treated, washout of 3 months is required.
- Written informed consent has been obtained during screening visit prior to any study specific procedure.
- Subject must understand the informed consent form and other study documents and are willing and able to comply with scheduled visits and requirements of the study protocol, including study specific Dietary Recommendations .
- Subject must be healthy or stabilized based on medical history and physical examination.
- Females of childbearing potential must have a negative pregnancy test at screening and agree to use a highly effective form of birth control while on study (from Screening through final study visit).
Who cannot join
- Pregnant or lactating females
- Specific feeding regimens if not stabilized between screening and baseline, especially those in conflict with study specific Dietary Recommendation.
- Subjects receiving therapies and medications, that may affect lipid levels. If used in the past, washout of 3 months is required.
- Subjects who have a medical condition or history that limits the subject to adhere to the protocol schedule and requirements:
- Known or suspected allergy to the content of investigational product
- Previous or ongoing severe medical or laboratory abnormality (acute or chronic) which, in the judgement of the investigator, would make the subject inappropriate for entry into the study
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- Subjects under a long-term treatment. Subjects stable for 30 days are allowed in the study
- Subjects with a history of acute myocardial infarction (AMI) or severe cardiac conditions
- Subjects with a history of alcoholism, drug and subjects with severe psychotic disorders (stable anti-depressive treatments are allowed)
- Subjects unable to understand and follow the study procedures
- Subjects who are currently participate in another interventional clinical study. Historical participation in a clinical study is allowed with 3 months of washout period (after last IMP dose).
- Subject with family or hierarchical relationships with the research team members at clinical site.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Poland1 site, 1 recruiting
- Recruiting
Polish Mother's memorial Hospital Research Institute
Lodz, 93338
Maciej Banach, Prof, +48 42 271 15 99, bozena.sosnowska@umed.lodz.pl
About this study
Official title: An International, Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Effect Of Artisterol On Metabolic And Vascular Risk Factors In Individuals With Suboptimal Cholesterol Levels
The goal of this clinical trial is to learn if Artisterol works to lower LDL cholesterol and other metabolic and vascular risk factors in adults. The main questions it aims to answer are:
- Does Artisterol lower low-density lipoprotein cholesterol (LDL-C) levels in participants and by how much? Researchers will compare Artisterol to a placebo (a look-alike substance that contains no drug) to see if Artisterol works to lower LDL cholesterol.
Participants will:
- Take drug Artisterol or a placebo every day for 3 months
- Visit the clinic once every 6 weeks for checkups and tests
- Keep a diary of their Artisterol intake and physical activity
Read the detailed description
This study is designed to test if a new food supplement, called Artisterol, can help lower cholesterol levels in adults. High cholesterol is a common health issue that increases the risk of heart disease by causing fatty buildups in the arteries. This research will provide evidence on the supplement's ability to decrease "bad" cholesterol (LDL-C) and will also check its safety and how well it is tolerated.
The supplement being tested, Artisterol, contains natural active ingredients including plant sterols, artichoke extract, and vitamin B1. The study will compare its effects to a placebo, which is a substance that looks and tastes identical but has no active ingredients.
This is a "randomized, double-blind, placebo-controlled" study. This means that participants will be randomly assigned, like flipping a coin, to one of two groups: one group will receive Artisterol, and the other will receive the placebo. The study is "double-blind," which means neither the participants nor the study doctors will know who is receiving the active supplement and who is receiving the placebo until the study is complete. This method helps prevent bias and ensures the results are reliable.
Who can participate? The study is looking for at least 106 adults, both men and women, between the ages of 18 and 70. Participants should have mildly high LDL-C ("bad" cholesterol) levels, specifically between 115 and 160 mg/dL, and not be currently taking medication to lower their cholesterol. Participants must be willing to follow the study's procedures and dietary recommendations. Individuals who are pregnant or breastfeeding, have certain severe medical conditions, or are allergic to the supplement's ingredients are not eligible to participate.
What does participation involve? The study involves a treatment period of 12 weeks. Participants will be asked to take one sachet of their assigned supplement (Artisterol or placebo) orally each day.
Participation includes:
- A screening visit (V1) to confirm eligibility, which involves signing an informed consent form, a physical exam, and blood tests.
- A baseline visit (V2) to be officially enrolled and receive the 12-week supply of the study supplement.
- Two follow-up clinic visits at Week 6 (V3) and Week 12 (V4) for physical check-ups and further blood sample collections.
The main goal of the study is to measure the change in participants' LDL-C levels from the beginning of the study to the end at Week 12. Researchers will compare the results between the group taking Artisterol and the group taking the placebo to see if the supplement is effective. The study will also look at changes in other blood fats (like total cholesterol and triglycerides) and markers for liver and metabolic health. Throughout the study, participants' health and safety will be carefully monitored.
- Conditions
- Hyperlipoproteinemia
- Being tested
- investigational product containing phytosterol, artichoke extract and thiamin, Placebo
- Medical subject headings
- Hyperlipoproteinemias
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
investigational product containing phytosterol, artichoke extract and thiaminDietary supplement
subjects will take the investigational product once daily
PlaceboOther
matching placebo administration
| Study group | Role | What they receive |
|---|---|---|
| Artisterol | Experimental | Not described Receives: Dietary Supplement: investigational product containing phytosterol, artichoke extract and thiamin |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute mean change in Low-density-lipoprotein-cholesterol levels / mg/dl
The absolute mean change in fasting Low-Density Lipoprotein Cholesterol (LDL-C) levels from baseline to Week 12.Units: mg/dL,
Measured: from baseline to Week 12
Secondary outcomes (7)
Absolute mean changes in Total Cholesterol, High-Density-Lipoprotein-Cholesterol, Non-High-Density-Lipoprotein-Cholesterol and Triglycerides / mg/dl
Absolute mean change in Total Cholesterol levels from baseline to Week 12. Units: mg/dl
Measured: from baseline to Week 12
Absolute mean change in Apolipoprotein-B level / mg/dl
Absolute mean change in Apolipoprotein B (ApoB) levels from baseline to Week 12. ApoB reflects the total number of atherogenic particles. Units: mg/dl
Measured: from baseline to Week 12
Absolute mean changes in glutamat-oxalacetat-transaminase, glutamate pyruvate transaminase, and gamma-glutamyl transferase levels
Absolute mean change in Aspartate Aminotransferase (also known as Glutamate Oxaloacetate Transaminase or GOT) levels from baseline to Week 12 / U/l Absolute mean change in Alanine Aminotransferase (also known as Glutamate Pyruvate Transaminase or GPT) levels from baseline to Week 12 / U/l Absolute mean change in Gamma-Glutamyl Transferase levels from baseline to Week 12 / U/l
Measured: from baseline to Week 12
Mean change in Fasting plasma glucose levels Unit: mg/dl
Absolute mean change in fasting plasma glucose levels from baseline to Week 12 / mg/dl
Measured: from baseline to Week 12
Number of Participants With Clinically Significant Physical Examination Abnormalities. Unit: participants
The number of participants who have physical examination findings assessed as "Abnormal, Clinically Significant" by the investigator at the end of the study. Assessment includes evaluation of general appearance, cardiovascular, respiratory, and gastrointestinal systems.
Measured: Week 12
Incidence of Concomitant Medication Use. Unit: participants
The number of participants experiencing at least one Adverse Event (AE) during the treatment period. An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
Measured: Baseline through Week 12
Incidence of Adverse Events (TEAEs) Unit: participants
The number of participants experiencing at least one Adverse Event (AE) during the treatment period. An AE is defined as any untoward medical occurrence in a participant which does not necessarily have a causal relationship with the treatment.
Measured: Baseline through Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2026
- Study start24 Apr 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperlipoproteinemiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zentiva, k.s.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07405814
- Sponsor's protocol ID
- CINARL1118125
- Status last verified
- May 2026
- First submitted
- 29 Sep 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An International, Randomized, Double-Blind, Placebo-Controlled Clinical Trial On The Effect Of Artisterol On Metabolic And Vascular Risk Factors In Individuals With Suboptimal Cholesterol Levels
- ClinicalTrials.gov ID
- NCT07405814
- Acronym / sponsor ID
- CINARL1118125
- Conditions
- Hyperlipoproteinemia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 106 participants (estimated)
- Lead sponsor
- Zentiva, k.s.Industry (pharma, biotech, devices)
- Study start
- 24 Apr 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 12 Feb 2026 (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 goal of this clinical trial is to learn if Artisterol works to lower LDL cholesterol and other metabolic and vascular risk factors in adults. The main questions it aims to answer are:
- Does Artisterol lower low-density lipoprotein cholesterol (LDL-C) levels in participants and by how much? Researchers will compare Artisterol to a placebo (a look-alike substance that contains no drug) to see if Artisterol works to lower LDL cholesterol.
Participants will:
- Take drug Artisterol or a placebo every day for 3 months
- Visit the clinic once every 6 weeks for checkups and tests
- Keep a diary of their Artisterol intake and physical activity
Detailed description
This study is designed to test if a new food supplement, called Artisterol, can help lower cholesterol levels in adults. High cholesterol is a common health issue that increases the risk of heart disease by causing fatty buildups in the arteries. This research will provide evidence on the supplement's ability to decrease "bad" cholesterol (LDL-C) and will also check its safety and how well it is tolerated.
The supplement being tested, Artisterol, contains natural active ingredients including plant sterols, artichoke extract, and vitamin B1. The study will compare its effects to a placebo, which is a substance that looks and tastes identical but has no active ingredients.
This is a "randomized, double-blind, placebo-controlled" study. This means that participants will be randomly assigned, like flipping a coin, to one of two groups: one group will receive Artisterol, and the other will receive the placebo. The study is "double-blind," which means neither the participants nor the study doctors will know who is receiving the active supplement and who is receiving the placebo until the study is complete. This method helps prevent bias and ensures the results are reliable.
Who can participate? The study is looking for at least 106 adults, both men and women, between the ages of 18 and 70. Participants should have mildly high LDL-C ("bad" cholesterol) levels, specifically between 115 and 160 mg/dL, and not be currently taking medication to lower their cholesterol. Participants must be willing to follow the study's procedures and dietary recommendations. Individuals who are pregnant or breastfeeding, have certain severe medical conditions, or are allergic to the supplement's ingredients are not eligible to participate.
What does participation involve? The study involves a treatment period of 12 weeks. Participants will be asked to take one sachet of their assigned supplement (Artisterol or placebo) orally each day.
Participation includes:
- A screening visit (V1) to confirm eligibility, which involves signing an informed consent form, a physical exam, and blood tests.
- A baseline visit (V2) to be officially enrolled and receive the 12-week supply of the study supplement.
- Two follow-up clinic visits at Week 6 (V3) and Week 12 (V4) for physical check-ups and further blood sample collections.
The main goal of the study is to measure the change in participants' LDL-C levels from the beginning of the study to the end at Week 12. Researchers will compare the results between the group taking Artisterol and the group taking the placebo to see if the supplement is effective. The study will also look at changes in other blood fats (like total cholesterol and triglycerides) and markers for liver and metabolic health. Throughout the study, participants' health and safety will be carefully monitored.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Artisterol | Experimental | Dietary Supplement: investigational product containing phytosterol, artichoke extract and thiamin |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female or male, 18-70 years old.
- Subjects with mild hypercholesterolemia previously untreated (LDL-C levels between 115 and 160 mg/dL. Note that the upper limit can be extended to 190 mg/dL in case of subject refusing another treatment or intolerant to statins or other lipid lowering therapies. If previously treated, washout of 3 months is required.
- Written informed consent has been obtained during screening visit prior to any study specific procedure.
- Subject must understand the informed consent form and other study documents and are willing and able to comply with scheduled visits and requirements of the study protocol, including study specific Dietary Recommendations .
- Subject must be healthy or stabilized based on medical history and physical examination.
Key exclusion criteria (12 listed)
- Pregnant or lactating females
- Specific feeding regimens if not stabilized between screening and baseline, especially those in conflict with study specific Dietary Recommendation.
- Subjects receiving therapies and medications, that may affect lipid levels. If used in the past, washout of 3 months is required.
- Subjects who have a medical condition or history that limits the subject to adhere to the protocol schedule and requirements:
- Subjects who are currently participate in another interventional clinical study. Historical participation in a clinical study is allowed with 3 months of washout period (after last IMP dose).
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 |
|---|---|---|
| investigational product containing phytosterol, artichoke extract and thiaminsubjects will take the investigational product once daily | Dietary supplement | Artisterol |
| Placebomatching placebo administration | Other | Placebo |
Primary outcome
Absolute mean change in Low-density-lipoprotein-cholesterol levels / mg/dl
Time frame: from baseline to Week 12
The absolute mean change in fasting Low-Density Lipoprotein Cholesterol (LDL-C) levels from baseline to Week 12.Units: mg/dL,
7 secondary outcomes
Absolute mean changes in Total Cholesterol, High-Density-Lipoprotein-Cholesterol, Non-High-Density-Lipoprotein-Cholesterol and Triglycerides / mg/dl
Time frame: from baseline to Week 12
Absolute mean change in Apolipoprotein-B level / mg/dl
Time frame: from baseline to Week 12
Absolute mean changes in glutamat-oxalacetat-transaminase, glutamate pyruvate transaminase, and gamma-glutamyl transferase levels
Time frame: from baseline to Week 12
Mean change in Fasting plasma glucose levels Unit: mg/dl
Time frame: from baseline to Week 12
Number of Participants With Clinically Significant Physical Examination Abnormalities. Unit: participants
Time frame: Week 12
Incidence of Concomitant Medication Use. Unit: participants
Time frame: Baseline through Week 12
Incidence of Adverse Events (TEAEs) Unit: participants
Time frame: Baseline through Week 12
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
Related trials for Hyperlipoproteinemia
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Early Detection of Familial Hypercholesterolaemia in Pre-school Children ( CzeCH-IT)
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing investigational product containing phytosterol, artichoke extract and thiamin in people with Hyperlipoproteinemia, run by Zentiva, k.s. at 1 site in Poland.
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 6 inclusion and 12 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: looking for participants now, as of the sponsor's last update on 12 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 Poland. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marek Ferkl, MD (+420 267 241 111, marek.ferkl@zentiva.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Absolute mean change in Low-density-lipoprotein-cholesterol levels / mg/dl (time frame: from baseline to Week 12). 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 12 May 2026.