Back to resultsComparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
Primary Purpose
Hypertension, Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Poland
Study Type
Interventional
Intervention
Complex product
Chokeberry extract in liposomal formulation
Chokeberry extract in traditional formulation
Placebo
Sponsored by
About this trial
This is an interventional other trial for Hypertension focused on measuring Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract
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.
Sites / Locations
- Centum Zdrowia Eter-Med sp. z o.o.
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)
Chokeberry extract in liposomal formulation
Chokeberry extract in traditional formulation
Placebo
Arm Description
Single oral dose - 2 capsules
Single oral dose - 2 capsules
Single oral dose - 2 capsules
Single oral dose - 2 capsules
Outcomes
Primary Outcome Measures
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
Glucose level
Comparison of glucose level
Systolic, diatolic blood pressure
Comparison of blood pressure
Secondary Outcome Measures
Insulin level
Comparison of insulin level
Homocysteine level
Comparison of homocysteine level
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Comparison of ALT and AST
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05988099
Brief Title
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
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
February 20, 2023 (Actual)
Primary Completion Date
July 28, 2023 (Actual)
Study Completion Date
July 28, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AronPharma Sp. z o. o.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypercholesterolemia
Keywords
Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium)
Arm Type
Experimental
Arm Description
Single oral dose - 2 capsules
Arm Title
Chokeberry extract in liposomal formulation
Arm Type
Active Comparator
Arm Description
Single oral dose - 2 capsules
Arm Title
Chokeberry extract in traditional formulation
Arm Type
Active Comparator
Arm Description
Single oral dose - 2 capsules
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Single oral dose - 2 capsules
Intervention Type
Dietary Supplement
Intervention Name(s)
Complex product
Intervention Description
400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
Intervention Type
Dietary Supplement
Intervention Name(s)
Chokeberry extract in liposomal formulation
Intervention Description
400 mg of chokeberry extract in liposomal formulation
Intervention Type
Dietary Supplement
Intervention Name(s)
Chokeberry extract in traditional formulation
Intervention Description
400 mg of chokeberry extract in traditional formulation
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo
Primary Outcome Measure Information:
Title
Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)
Description
Comparison of lipid panel markers
Time Frame
baseline, 6 weeks
Title
Glucose level
Description
Comparison of glucose level
Time Frame
baseline, 6 weeks
Title
Systolic, diatolic blood pressure
Description
Comparison of blood pressure
Time Frame
baseline, 6 weeks
Secondary Outcome Measure Information:
Title
Insulin level
Description
Comparison of insulin level
Time Frame
baseline, 6 weeks
Title
Homocysteine level
Description
Comparison of homocysteine level
Time Frame
baseline, 6 weeks
Title
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Description
Comparison of ALT and AST
Time Frame
baseline, 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Centum Zdrowia Eter-Med sp. z o.o.
City
Gdańsk
ZIP/Postal Code
80-822
Country
Poland
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
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