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

AronPharma

Status: Completed

Conditions: Hypertension; Hypercholesterolemia

Treatments: Dietary Supplement: Chokeberry extract in traditional formulation; Other: Placebo; Dietary Supplement: Chokeberry extract in liposomal formulation; Dietary Supplement: Complex product

Study type: Interventional

Funder types: Industry

Identifiers

NCT05988099

04-AP-MEL

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 4 patient groups, including a placebo group

Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)

Experimental group

Description:

Single oral dose - 2 capsules

Treatment:

Dietary Supplement: Complex product

Chokeberry extract in liposomal formulation

Active Comparator group

Description:

Single oral dose - 2 capsules

Treatment:

Dietary Supplement: Chokeberry extract in liposomal formulation

Chokeberry extract in traditional formulation

Active Comparator group

Description:

Single oral dose - 2 capsules

Treatment:

Dietary Supplement: Chokeberry extract in traditional formulation

Placebo

Placebo Comparator group

Description:

Single oral dose - 2 capsules

Treatment:

Other: Placebo