NCT07405814

Clinical Trial On The Effect Of Artisterol On Risk Factors In Individuals With Suboptimal Cholesterol Levels

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 106 (estimated)
• Sponsor: Zentiva, k.s. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Hyperlipoproteinemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	investigational product containing phytosterol, artichoke extract and thiamin	subjects will take the investigational product once daily
OTHER	Placebo	matching placebo administration

Timeline

• Start date: 2026-02-02
• Primary completion: 2026-10-31
• Completion: 2026-10-31
• First posted: 2026-02-12
• Last updated: 2026-02-12