HypertensionNCT05988099
Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
A study testing Complex product, Chokeberry extract in liposomal formulation and Chokeberry extract in traditional formulation in people with Hypertension and Hypercholesterolemia, run by AronPharma Sp. z o. o. at 1 site in Poland.
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Hypertension, Hypercholesterolemia
- What is being tested?
- Complex product, Chokeberry extract in liposomal formulation and Chokeberry extract in traditional formulation
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 sitePoland
- Study dates
- 20 Feb 2023to 28 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Hypertension, Hypercholesterolemia
- Being tested
- Complex product, Chokeberry extract in liposomal formulation, Chokeberry extract in traditional formulation, Placebo
- Keywords
- Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract
- Medical subject headings
- Hypertension, Hypercholesterolemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Complex productDietary supplement
400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium
Chokeberry extract in liposomal formulationDietary supplement
400 mg of chokeberry extract in liposomal formulation
Chokeberry extract in traditional formulationDietary supplement
400 mg of chokeberry extract in traditional formulation
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium) | Experimental | Single oral dose - 2 capsules Receives: Dietary Supplement: Complex product |
| Chokeberry extract in liposomal formulation | Active comparator | Single oral dose - 2 capsules Receives: Dietary Supplement: Chokeberry extract in liposomal formulation |
| Chokeberry extract in traditional formulation | Active comparator | Single oral dose - 2 capsules Receives: Dietary Supplement: Chokeberry extract in traditional formulation |
| Placebo | Placebo comparator | Single oral dose - 2 capsules Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline, 6 weeks
Glucose level
Comparison of glucose level
Measured: baseline, 6 weeks
Systolic, diatolic blood pressure
Comparison of blood pressure
Measured: baseline, 6 weeks
Secondary outcomes (3)
Insulin level
Comparison of insulin level
Measured: baseline, 6 weeks
Homocysteine level
Comparison of homocysteine level
Measured: baseline, 6 weeks
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Comparison of ALT and AST
Measured: baseline, 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2023
- Study start20 Feb 2023
- Primary completion28 Jul 2023
- Study completion28 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- AronPharma Sp. z o. o.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05988099
- Sponsor's protocol ID
- 04-AP-MEL
- Status last verified
- Aug 2023
- First submitted
- 4 Aug 2023
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Standardized Chokeberry Extracts With Various Formulations on the Levels of Selected Markers Associated With Cardiovascular Disease
- ClinicalTrials.gov ID
- NCT05988099
- Acronym / sponsor ID
- 04-AP-MEL
- Conditions
- Hypertension, Hypercholesterolemia
- Keywords
- Hypertension, Hypercholesterolemia, Aronia extract, Chokeberry extract
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- AronPharma Sp. z o. o.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2023 (actual)
- Primary completion
- 28 Jul 2023 (actual)
- Study completion
- 28 Jul 2023 (actual)
- First posted
- 14 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium) | Experimental | Dietary Supplement: Complex productSingle oral dose - 2 capsules |
| Chokeberry extract in liposomal formulation | Active comparator | Dietary Supplement: Chokeberry extract in liposomal formulationSingle oral dose - 2 capsules |
| Chokeberry extract in traditional formulation | Active comparator | Dietary Supplement: Chokeberry extract in traditional formulationSingle oral dose - 2 capsules |
| Placebo | Placebo comparator | Other: PlaceboSingle oral dose - 2 capsules |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Complex product400 mg of chokeberry extract in liposomal formulation and L-arginine, vitamin E, vitamin A, folic acid, chromium | Dietary supplement | Complex product (chokeberry extract, L-arginine, vitamin E, vitamin A, folic acid, chromium) |
| Chokeberry extract in liposomal formulation400 mg of chokeberry extract in liposomal formulation | Dietary supplement | Chokeberry extract in liposomal formulation |
| Chokeberry extract in traditional formulation400 mg of chokeberry extract in traditional formulation | Dietary supplement | Chokeberry extract in traditional formulation |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B)
Time frame: baseline, 6 weeks
Comparison of lipid panel markers
Glucose level
Time frame: baseline, 6 weeks
Comparison of glucose level
Systolic, diatolic blood pressure
Time frame: baseline, 6 weeks
Comparison of blood pressure
3 secondary outcomes
Insulin level
Time frame: baseline, 6 weeks
Homocysteine level
Time frame: baseline, 6 weeks
Alanine aminotransferase (ALT), aspartate aminotransferase (AST)
Time frame: baseline, 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Complex product, Chokeberry extract in liposomal formulation and Chokeberry extract in traditional formulation in people with Hypertension and Hypercholesterolemia, run by AronPharma Sp. z o. o. at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Extended lipid panel (total cholesterol (TC), triglycerides (TG), low-density lipoprotein (LDL), HDL and lipoprotein A, apolipoprotein Apo A1 and Apo B) (time frame: baseline, 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.