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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium) | Experimental | Single oral dose - 2 capsules |
|
| Chokeberry extract in liposomal formulation | Active Comparator | Single oral dose - 2 capsules |
|
| Chokeberry extract in traditional formulation | Active Comparator | Single oral dose - 2 capsules |
|
| Placebo | Placebo Comparator | Single oral dose - 2 capsules |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Complex product | Dietary Supplement | 400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium |
|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin level | Comparison of insulin level | baseline, 6 weeks |
| Homocysteine level | Comparison of homocysteine level | baseline, 6 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centum Zdrowia Eter-Med sp. z o.o. | Gdansk | 80-822 | Poland |
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| Chokeberry extract in liposomal formulation | Dietary Supplement | 400 mg of chokeberry extract in liposomal formulation |
|
| Chokeberry extract in traditional formulation | Dietary Supplement | 400 mg of chokeberry extract in traditional formulation |
|
| Placebo | Other | Placebo |
|
| Alanine aminotransferase (ALT), aspartate aminotransferase (AST) | Comparison of ALT and AST | baseline, 6 weeks |
| ID | Term |
|---|---|
| D006973 | Hypertension |
| D006937 | Hypercholesterolemia |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006949 | Hyperlipidemias |
| D050171 | Dyslipidemias |
| D052439 | Lipid Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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