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

NCT ID: NCT05988099

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-02-20

Study Completion Date

2023-07-28

Brief Summary

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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

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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.

Conditions

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Hypertension Hypercholesterolemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)

Single oral dose - 2 capsules

Group Type EXPERIMENTAL

Complex product

Intervention Type 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

Single oral dose - 2 capsules

Group Type ACTIVE_COMPARATOR

Chokeberry extract in liposomal formulation

Intervention Type DIETARY_SUPPLEMENT

400 mg of chokeberry extract in liposomal formulation

Chokeberry extract in traditional formulation

Single oral dose - 2 capsules

Group Type ACTIVE_COMPARATOR

Chokeberry extract in traditional formulation

Intervention Type DIETARY_SUPPLEMENT

400 mg of chokeberry extract in traditional formulation

Placebo

Single oral dose - 2 capsules

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo

Interventions

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Complex product

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

Intervention Type DIETARY_SUPPLEMENT

Chokeberry extract in liposomal formulation

400 mg of chokeberry extract in liposomal formulation

Intervention Type DIETARY_SUPPLEMENT

Chokeberry extract in traditional formulation

400 mg of chokeberry extract in traditional formulation

Intervention Type DIETARY_SUPPLEMENT

Placebo

Placebo

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AronPharma Sp. z o. o.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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

Gdansk, , Poland

Site Status

Countries

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Poland

Other Identifiers

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04-AP-MEL

Identifier Type: -

Identifier Source: org_study_id

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