Comparison of the effects of standardized Aronia extract on the levels of selected markers associated with cardiovascular disease. (Commercial product Melarginol®)
- Bioethics Committee Approval Number:
(12)17/2023/24.01.2023 - NCT Number:
clinicaltrials.govStatus:
study completed
The aim of the study was to compare, under clinical conditions, the effect of standardized chokeberry extract in different formulations and a comprehensive product (MELARGINOL®), which, in addition to chokeberry, contains other active ingredients, on the levels of selected markers associated with cardiovascular diseases in individuals predisposed to developing these conditions.
Chokeberry extract, rich in polyphenols, positively influences the cardiovascular system by delaying the progression of atherosclerosis through the regulation of signaling and transcriptional pathways, antioxidant activity, preventing leukocyte migration and subsequent infiltration into atherosclerotic plaque. Additionally, it reduces blood pressure by increasing NO production, improves lipid metabolism, and exhibits hypoglycemic effects. [1] L-arginine helps maintain appropriate NO levels, thereby normalizing blood pressure. [2] Vitamin E and chromium prevent the accumulation of atherosclerotic plaques in blood vessels. [3] Folic acid improves blood vessel function, reduces blood homocysteine levels, which is considered a factor influencing the development of cardiovascular diseases. [4]
The study includes the following groups:
- receiving a placebo,
- receiving chokeberry extract in traditional form,
- receiving chokeberry extract in liposomal form,
- receiving the comprehensive product MELARGINOL®.
The study group consists of adults diagnosed with: hypertension and/or dyslipidemia, who are overweight or obese.
As part of the study, biochemical parameters related to lipid metabolism and liver and kidney function will be measured. Additionally, anthropometric parameters will be measured, and blood pressure analysis will be conducted.
[1] Jurikova T, Mlcek J, Skrovankova S, Sumczynski D, Sochor J, Hlavacova I, Snopek L, Orsavova J. Fruits of Black Chokeberry Aronia melanocarpa in the Prevention of Chronic Diseases. Molecules. 2017 Jun 7;22(6):944.
[2] Li H, Liu Q, Zou Z, Chen Q, Wang W, Baccarelli AA, Deng F, Guo X, Wu S. L-arginine supplementation to mitigate cardiovascular effects of walking outside in the context of traffic-related air pollution in participants with elevated blood pressure: A randomized, double-blind, placebo-controlled trial. Environ Int. 2021 Nov;156:106631.
[3] Shah S, Shiekh Y, Lawrence JA, Ezekwueme F, Alam M, Kunwar S, Gordon DK. A Systematic Review of Effects of Vitamin E on the Cardiovascular System. Cureus. 2021 Jun 12;13(6):e15616.
[4] Jenkins DJA, Spence JD, Giovannucci EL, Kim YI, Josse R, Vieth R, Blanco Mejia S, Viguiliouk E, Nishi S, Sahye-Pudaruth S, Paquette M, Patel D, Mitchell S, Kavanagh M, Tsirakis T, Bachiri L, Maran A, Umatheva N, McKay T, Trinidad G, Bernstein D, Chowdhury A, Correa-Betanzo J, Del Principe G, Hajizadeh A, Jayaraman R, Jenkins A, Jenkins W, Kalaichandran R, Kirupaharan G, Manisekaran P, Qutta T, Shahid R, Silver A, Villegas C, White J, Kendall CWC, Pichika SC, Sievenpiper JL. Supplemental Vitamins and Minerals for CVD Prevention and Treatment. J Am Coll Cardiol. 2018 Jun 5;71(22):2570-2584.