Effect of Artisterol on LDL cholesterol and vascular risk factors in adults with mildly high cholesterol

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

This test will see if the daily supplement Artisterol lowers LDL ('bad') cholesterol and other metabolic or vascular risk factors in adults with mildly high LDL who are not taking cholesterol-lowering medications.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 106 (estimated)
• Ages: 18 Years to 70 Years
• Sex: All
• Sponsor: Zentiva, k.s. (Industry-sponsored)
• Locations: 1 site (Lodz)
• Trial ID: NCT07405814 on ClinicalTrials.gov

What this trial studies

This randomized, double-blind, placebo-controlled study will assign about 106 adults aged 18–70 with LDL‑C between 115 and 160 mg/dL (with possible extension to 190 mg/dL in specific statin‑intolerant or refusing cases) to take Artisterol or a matching placebo daily for three months. The investigational product contains plant sterols, artichoke extract, and vitamin B1 and will be compared to placebo to measure changes in LDL‑C and other metabolic and vascular risk markers. Participants will attend clinic visits every six weeks for testing and safety assessments and will keep a diary of supplement intake and physical activity. Safety, tolerability, and any adverse events will be recorded throughout the study.

Who should consider this trial

Good fit: Adults 18–70 with untreated mild hypercholesterolemia (typical LDL‑C 115–160 mg/dL, or up to 190 mg/dL for certain statin‑intolerant/refusing individuals) who can comply with clinic visits, study dietary recommendations, and contraception requirements are ideal candidates.

Not a fit: Individuals who require prescription lipid-lowering therapy, those currently on such medications without a 3-month washout, pregnant or breastfeeding women, and people with unstable medical conditions are unlikely to receive benefit from this supplement.

Why it matters

Potential benefit: If successful, Artisterol may lower LDL cholesterol and modestly reduce cardiovascular risk for people with mild hypercholesterolemia.

How similar studies have performed: Previous studies of products containing plant sterols and artichoke extract have reported modest LDL‑lowering effects, so this trial builds on existing, preliminary evidence.

Eligibility criteria

Inclusion Criteria:

1. Female or male, 18-70 years old.
2. 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.
3. Written informed consent has been obtained during screening visit prior to any study specific procedure.
4. 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 .
5. Subject must be healthy or stabilized based on medical history and physical examination.
6. 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).

Exclusion Criteria:

1. Pregnant or lactating females
2. Specific feeding regimens if not stabilized between screening and baseline, especially those in conflict with study specific Dietary Recommendation.
3. Subjects receiving therapies and medications, that may affect lipid levels. If used in the past, washout of 3 months is required.
4. Subjects who have a medical condition or history that limits the subject to adhere to the protocol schedule and requirements:

   1. Known or suspected allergy to the content of investigational product
   2. 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
   3. Subjects under a long-term treatment. Subjects stable for 30 days are allowed in the study
   4. Subjects with a history of acute myocardial infarction (AMI) or severe cardiac conditions
   5. Subjects with a history of alcoholism, drug and subjects with severe psychotic disorders (stable anti-depressive treatments are allowed)
   6. Subjects unable to understand and follow the study procedures
5. 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).
6. Subject with family or hierarchical relationships with the research team members at clinical site.

Where this trial is running

Lodz

• Polish Mother's memorial Hospital Research Institute — Lodz, Poland (Recruiting)

Study contacts

• Study coordinator: Marek Ferkl, MD

Conditions Hyperlipoproteinemia