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
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 .
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.
Known or suspected allergy to the content of investigational product
Parallel
investigational product containing phytosterol, artichoke extract and thiamin
Dietary supplementsubjects will take the investigational product once daily
Placebo
Other interventionmatching placebo administration
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,
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
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
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
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
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