NCT05988099

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: AronPharma Sp. z o. o. · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hypertension
• Hypercholesterolemia

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Complex product	400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
DIETARY_SUPPLEMENT	Chokeberry extract in liposomal formulation	400 mg of chokeberry extract in liposomal formulation
DIETARY_SUPPLEMENT	Chokeberry extract in traditional formulation	400 mg of chokeberry extract in traditional formulation
OTHER	Placebo	Placebo

Timeline

• Start date: 2023-02-20
• Primary completion: 2023-07-28
• Completion: 2023-07-28
• First posted: 2023-08-14
• Last updated: 2023-08-23

Locations

1 site across 1 country: Poland