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

AronPharma Sp. z o. o.40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

Conditions

Hypertension Hypercholesterolemia

Interventions

Complex productDIETARY_SUPPLEMENT

400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium

Chokeberry extract in liposomal formulationDIETARY_SUPPLEMENT

400 mg of chokeberry extract in liposomal formulation

Chokeberry extract in traditional formulationDIETARY_SUPPLEMENT

400 mg of chokeberry extract in traditional formulation

Eligibility

Sex: ALLMin age: 18 YearsMax age: 55 Years

Medical Language ↔ Plain English

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.

Locations (1)

Centum Zdrowia Eter-Med sp. z o.o.

Gdansk, Poland

Outcomes

Primary Outcomes

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

Time frame: baseline, 6 weeks

Glucose level

Comparison of glucose level

Time frame: baseline, 6 weeks

Systolic, diatolic blood pressure

Comparison of blood pressure

Time frame: baseline, 6 weeks

Secondary Outcomes

Insulin level

Comparison of insulin level

Time frame: baseline, 6 weeks

Homocysteine level

Comparison of homocysteine level

Time frame: baseline, 6 weeks

Alanine aminotransferase (ALT), aspartate aminotransferase (AST)

Comparison of ALT and AST

Time frame: baseline, 6 weeks

Data from ClinicalTrials.gov

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