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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artisterol | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| investigational product containing phytosterol, artichoke extract and thiamin | Dietary Supplement | subjects will take the investigational product once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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, | from baseline to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from baseline to Week 12 |
| Absolute mean change in Apolipoprotein-B level / mg/dl |
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Inclusion Criteria:
Exclusion Criteria:
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).
Subject with family or hierarchical relationships with the research team members at clinical site.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Marek Ferkl, MD | Contact | +420 267 241 111 | marek.ferkl@zentiva.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Polish Mother's memorial Hospital Research Institute | Recruiting | Lodz | 93338 | Poland |
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| ID | Term |
|---|---|
| D006951 | Hyperlipoproteinemias |
| ID | Term |
|---|---|
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| D013831 | Thiamine |
| ID | Term |
|---|---|
| D013844 | Thiazoles |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D001393 | Azoles |
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| Placebo | Other | matching placebo administration |
|
Absolute mean change in Apolipoprotein B (ApoB) levels from baseline to Week 12. ApoB reflects the total number of atherogenic particles. Units: mg/dl |
| 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 | 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 | 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. | 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. | 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. | Baseline through Week 12 |
| D009750 |
| Nutritional and Metabolic Diseases |
| D006573 |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |