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

Not Applicable

Completed

• Conditions: Hypertension; Hypercholesterolemia
• Interventions: Other: Placebo; Dietary Supplement: Complex product; Dietary Supplement: Chokeberry extract in traditional formulation; Dietary Supplement: Chokeberry extract in liposomal formulation

• Registration Number: NCT05988099
• Lead Sponsor: AronPharma Sp. z o. o.

Brief 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.

Study Timeline

• Study Start: 2023-02-20
• Primary Completion: 2023-07-28
• Study Completion: 2023-07-28
• Status Verified: 2023-08
• Study First Submitted: 2023-08-04
• Study First Submitted QC: 2023-08-04
• Study First Posted: 2023-08-14
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Single oral dose - 2 capsules
Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)	Complex product	Single oral dose - 2 capsules
Chokeberry extract in traditional formulation	Chokeberry extract in traditional formulation	Single oral dose - 2 capsules
Chokeberry extract in liposomal formulation	Chokeberry extract in liposomal formulation	Single oral dose - 2 capsules

Primary Outcome Measures

Name	Time	Method
Glucose level	baseline, 6 weeks	Comparison of glucose level
Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)	baseline, 6 weeks	Comparison of lipid panel markers
Systolic, diatolic blood pressure	baseline, 6 weeks	Comparison of blood pressure

Secondary Outcome Measures

Name	Time	Method
Homocysteine level	baseline, 6 weeks	Comparison of homocysteine level
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)	baseline, 6 weeks	Comparison of ALT and AST
Insulin level	baseline, 6 weeks	Comparison of insulin level

Trial Locations

Locations (1)

Centum Zdrowia Eter-Med sp. z o.o.; 🇵🇱 Gdańsk, Poland