Clinical trial NCT05988099: Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
Official title: Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Hypercholesterolemia
Keywords: Hypertension
Hypercholesterolemia
Aronia extract
Chokeberry extract
Lead sponsor: AronPharma Sp. z o. o.
Sponsor class: INDUSTRY
First posted: 2023-08-14
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)
timeFrame: baseline, 6 weeks
measure: Glucose level
timeFrame: baseline, 6 weeks
measure: Systolic, diatolic blood pressure
timeFrame: baseline, 6 weeks
Secondary outcomes:
measure: Insulin level
timeFrame: baseline, 6 weeks
measure: Homocysteine level
timeFrame: baseline, 6 weeks
measure: Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
timeFrame: baseline, 6 weeks
Other outcomes:
Locations:
city: Gdańsk
country: Poland
facility: Centum Zdrowia Eter-Med sp. z o.o.
Study officials:
References: