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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05988099
• Other study ID #: 04-AP-MEL
• Status: Completed
• Phase: N/A
• Start date: February 20, 2023
• Est. completion date: July 28, 2023

Study information

• Verified date: August 2023
• Source: AronPharma Sp. z o. o.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: July 28, 2023
• Est. primary completion date: July 28, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypercholesterolemia
• Hypertension

Intervention

Dietary Supplement:
• Complex product
400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
• Chokeberry extract in liposomal formulation
400 mg of chokeberry extract in liposomal formulation
• Chokeberry extract in traditional formulation
400 mg of chokeberry extract in traditional formulation

Other:
• Placebo
Placebo

Locations

Country	Name	City	State
Poland	Centum Zdrowia Eter-Med sp. z o.o.	Gdansk

Sponsors (1)

Lead Sponsor	Collaborator
AronPharma Sp. z o. o.

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Glucose level	Comparison of glucose level	baseline, 6 weeks
Primary	Systolic, diatolic blood pressure	Comparison of blood pressure	baseline, 6 weeks
Secondary	Insulin level	Comparison of insulin level	baseline, 6 weeks
Secondary	Homocysteine level	Comparison of homocysteine level	baseline, 6 weeks
Secondary	Alanine aminotransferase (ALT), aspartate aminotransferase (AST)	Comparison of ALT and AST	baseline, 6 weeks