Skip to main content
OpenTrials
Completed

NCT Number: NCT05988099

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Gdansk, 80-822, Poland

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Complex product

Dietary Supplement

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

Chokeberry extract in liposomal formulation

Dietary Supplement

400 mg of chokeberry extract in liposomal formulation

Chokeberry extract in traditional formulation

Dietary Supplement

400 mg of chokeberry extract in traditional formulation

Placebo

Other

Placebo

Primary outcomes

  1. Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)

    Time frame: baseline, 6 weeks

    Comparison of lipid panel markers

  2. Glucose level

    Time frame: baseline, 6 weeks

    Comparison of glucose level

  3. Systolic, diatolic blood pressure

    Time frame: baseline, 6 weeks

    Comparison of blood pressure

Secondary outcomes

  1. Insulin level

    Time frame: baseline, 6 weeks

    Comparison of insulin level

  2. Homocysteine level

    Time frame: baseline, 6 weeks

    Comparison of homocysteine level

  3. Alanine aminotransferase (ALT), aspartate aminotransferase (AST)

    Time frame: baseline, 6 weeks

    Comparison of ALT and AST

Sponsors and collaborators

Lead sponsor

AronPharma Sp. z o. o.

Industry

Registry information

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Aug 14, 2023
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.