Hypercholesterolemia, Hypertension
Conditions
Keywords
Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTComplex product
400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
DIETARY_SUPPLEMENTChokeberry extract in liposomal formulation
400 mg of chokeberry extract in liposomal formulation
DIETARY_SUPPLEMENTChokeberry extract in traditional formulation
400 mg of chokeberry extract in traditional formulation
OTHERPlacebo
Placebo
Sponsors
AronPharma Sp. z o. o.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B) | baseline, 6 weeks | Comparison of lipid panel markers |
| Glucose level | baseline, 6 weeks | Comparison of glucose level |
| Systolic, diatolic blood pressure | baseline, 6 weeks | Comparison of blood pressure |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin level | baseline, 6 weeks | Comparison of insulin level |
| Homocysteine level | baseline, 6 weeks | Comparison of homocysteine level |
| Alanine aminotransferase (ALT), aspartate aminotransferase (AST) | baseline, 6 weeks | Comparison of ALT and AST |
Countries
Poland
Outcome results
None listed