Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease

Study Overview
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Brief Summary
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The aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other active ingredients in on the levels of selected markers associated with cardiovascular diseases in people with a predisposition to the development of these diseases.

Detailed Description
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Randomized, double-blind, parallel study conducted under medical supervision on a group of 40 patients with known hypertension and/or hypercholesterolemia. Patients receive one of the investigational products or placebo for 6 weeks. Before and after the study, the following parameters are analyzed: extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B), levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine aminotransferase (ALT), aspartate aminotransferase (AST), lactate dehydrogenase (LDH), blood urea nitrogen (BUN), uric acid). Effects on blood pressure and anthropometric parameters are also being evaluated.

Official Title
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Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease

Conditions
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Hypertension, Hypercholesterolemia

Intervention / Treatment
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* Dietary Supplement: Complex product
* Dietary Supplement: Chokeberry extract in liposomal formulation
* Dietary Supplement: Chokeberry extract in traditional formulation
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women and men, 18-55 years old Patients with known: hypertension or hypercholesterolemia, Patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment Signed informed consent Exclusion Criteria: Intake of supplements containing plant extracts, polyphenols or anthocyanins, Intake of supplements with antioxidant properties, Participation in another clinical trial, Women who are pregnant, planning to become pregnant during the study, or breastfeeding, Oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, AIDS, rheumatoid arthritis, organ transplant, Patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease. Patients with signs of inflammation such as increased body temperature, redness, swelling, pain. Patients who have not given written consent to participate in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)<br>Single oral dose - 2 capsules | Dietary Supplement: Complex product<br>* 400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium<br>|
| Active Comparator: Chokeberry extract in liposomal formulation<br>Single oral dose - 2 capsules | Dietary Supplement: Chokeberry extract in liposomal formulation<br>* 400 mg of chokeberry extract in liposomal formulation<br>|
| Active Comparator: Chokeberry extract in traditional formulation<br>Single oral dose - 2 capsules | Dietary Supplement: Chokeberry extract in traditional formulation<br>* 400 mg of chokeberry extract in traditional formulation<br>|
| Placebo Comparator: Placebo<br>Single oral dose - 2 capsules | Other: Placebo<br>* Placebo<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B) | Comparison of lipid panel markers | baseline, 6 weeks | 
| Glucose level | Comparison of glucose level | baseline, 6 weeks | 
| Systolic, diatolic blood pressure | Comparison of blood pressure | baseline, 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin level | Comparison of insulin level | baseline, 6 weeks | 
| Homocysteine level | Comparison of homocysteine level | baseline, 6 weeks | 
| Alanine aminotransferase (ALT), aspartate aminotransferase (AST) | Comparison of ALT and AST | baseline, 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract