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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Hypercholesterolemia
• Intervention / Treatment: Other: Placebo; Dietary supplement: Complex product; Dietary supplement: Chokeberry extract in liposomal formulation; Dietary supplement: Chokeberry extract in traditional formulation

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.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Gdańsk, Poland, 80-822
    • Centum Zdrowia Eter-Med sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium); Single oral dose - 2 capsules	Dietary supplement: Complex product; 400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
Active Comparator: Chokeberry extract in liposomal formulation; Single oral dose - 2 capsules	Dietary supplement: Chokeberry extract in liposomal formulation; 400 mg of chokeberry extract in liposomal formulation
Active Comparator: Chokeberry extract in traditional formulation; Single oral dose - 2 capsules	Dietary supplement: Chokeberry extract in traditional formulation; 400 mg of chokeberry extract in traditional formulation
Placebo Comparator: Placebo; Single oral dose - 2 capsules	Other: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	baseline, 6 weeks
Glucose level	Comparison of glucose level	baseline, 6 weeks
Systolic, diatolic blood pressure	Comparison of blood pressure	baseline, 6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insulin level	Comparison of insulin level	baseline, 6 weeks
Homocysteine level	Comparison of homocysteine level	baseline, 6 weeks
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)	Comparison of ALT and AST	baseline, 6 weeks

Collaborators and Investigators

• Sponsor: AronPharma Sp. z o. o.

Study record dates

Study Major Dates

• Study Start (Actual): February 20, 2023
• Primary Completion (Actual): July 28, 2023
• Study Completion (Actual): July 28, 2023

Study Registration Dates

• First Submitted: August 4, 2023
• First Submitted That Met QC Criteria: August 4, 2023
• First Posted (Actual): August 14, 2023

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Hypertension; Hypercholesterolemia; Aronia extract; Chokeberry extract
• Additional Relevant MeSH Terms: Vascular Diseases; Metabolic Diseases; Lipid Metabolism Disorders; Hyperlipidemias; Dyslipidemias; Hypertension; Cardiovascular Diseases; Hypercholesterolemia
• Other Study ID Numbers: 04-AP-MEL

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No