Essential HypertensionAROBLENDONCT05912322
Evaluation of Black Chokeberry Bio Juice on Blood Pressure Levels and Endothelial Damage
A study testing Black chokeberry juice in people with Essential Hypertension and Endothelial Dysfunction, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
Trial summary
In Romania, the diseases of the circulatory system account for 59.3% of deaths, representing the main cause of morbidity and mortality. Barriers of current pharmacological treatments materialized in side effects and limited actions on risk factors increase the necessity of finding more effective, multi-target and less… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Essential Hypertension, Endothelial Dysfunction, Inflammation
- What is being tested?
- Black chokeberry juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Jun 2022to 30 Sep 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- informed consent form signed,
- BP values: 130 - 159 / 85 - 99 mmHg (high normal BP and grade 1 HTN) at low-moderate CV risk (a calculated SCORE=1-5%)
- under no concomitant medications
Who cannot join
- refusal to participate,
- BP ≥ 140/90mmHg with high CV risk,
- acute/chronic administration of any pharmacological treatment during the study period,
- other CV or cerebrovascular pathologies,
- congenital disorders,
- liver/renal diseases,
Show all 12Show fewer
- history/presence of peptic ulcer,
- acute/chronic inflammatory conditions,
- hypersensibility to black chokeberry juice,
- diabetes mellitus,
- gout,
- pregnancy/breast feeding mother
Trial locations and contacts
1 site in 1 country.
Romania1 site
ASCAR Cardiology Clinic of Timisoara City Hospital
Timișoara, Timiș County, 300337
About this study
Official title: A Comprehensive in Vivo Evaluation of Aronia Melanocarpa (Michx.) Elliott Bio Juice on Blood Pressure Levels and Endothelial Damage
In Romania, the diseases of the circulatory system account for 59.3% of deaths, representing the main cause of morbidity and mortality.
Barriers of current pharmacological treatments materialized in side effects and limited actions on risk factors increase the necessity of finding more effective, multi-target and less toxic therapeutic strategies. Considering the well-known benefits, natural compounds represent a very important source for drug candidates.
Read more
The latest in vitro and in vivo studies on Aronia melanocarpa (Michx.) Elliott have highlighted its antioxidant, anti-inflammatory, anti-proliferative, anti-atherosclerotic, hypotensive, antiplatelet, lipid and glucose reduction properties, making it an excellent candidate for the prevention and treatment of cardiovascular and metabolic disorders.
The aim of this study is to comprehensive evaluate (in vivo) the Aronia melanocarpa bio juice, obtained from Romania on blood pressure levels and endothelial damage.
Read the detailed description
Patients at risk of developing hypertension (HTN) or suspicion of HTN will be invited for a visit in the Cardiology Clinic of Timisoara City Hospital. After performing the investigations for the suspicion of HTN in the Clinic, the diagnosis of HTN (>140/90mmHg) or pre-HTN (130-139/85-89mmHg) will be made after 24h monitorization, based on the results of Ambulatory Pressure Monitoring Device(ABPM). In function of the results and the patients' risk factors, a treatment strategy (pharmacological or non-pharmacological) will be implemented. Patients who fit the inclusion criteria will be asked to join the study. Study design: Prospective study of 3 months period. The included patients (≈ 100 patients) will be randomized (1:1) in two groups (one receiving 100ml black chokeberry juice (AMJ)/day and one control group, both under lifestyle changes), matched be age, sex and characteristics. The complete list of analysis and investigations will be performed at the inclusion of the study (T0), after 3 months (T3) of non-pharmacological treatment. Periodical phone calls (each 4 weeks) will be made by the clinical pharmacist to assess the health status, adherence, eventual problems of the treatment or difficulty to accomplish the targets. If any of the included patients will develop problems during the proposed treatment (ex: higher blood pressure levels) they will be excluded from the study and classical pharmacological treatment will be applied.
Investigations: familial and personal history of cardiovascular (CV) disease/renal disease and associated risk factors; smoking/drinking/substance abuse/dietary habits, blood pressure measurements, heart rate, weight, height, 12-lead electrocardiography, echocardiography (cardiac, vascular and abdominal), carotid intima-media thickness (IMT), flow mediated vasodilation (FMD), laboratory evaluation of venous blood samples (morning, fasting state >8h harvested on anticoagulant) and urine analysis. The complete blood count, electrolytes, hepatic, renal, lipid, triglycerides and glucose profile of venous blood sample and the urine analysis will be performed by routine laboratory analysis in the Cardiology Clinic. Quantification of several special markers of endothelial injury will be performed, such as: pentraxin-3, soluble endoglin (sEng), endothelin-1; asymmetric dimethylarginine (ADMA). The imagistic investigations will be performed by the same certified cardiologist.
- Being tested
- Black chokeberry juice
- Keywords
- black chokeberry, cardiovascular effects, essential arterial hypertension, endothelial dysfunction
- Medical subject headings
- Essential Hypertension, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black chokeberry juiceDietary supplement
100ml black chokeberry juice/day
| Study group | Role | What they receive |
|---|---|---|
| Black chokeberry juice | Experimental | 100ml black chokeberry juice/day Receives: Dietary Supplement: Black chokeberry juice |
| Control | No intervention | Lifestyle changes. No juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normalization of blood pressure levels
By inhibition of angiotensin I-converting enzyme (ACE). Measurements performed at the same hour/once a day (expressed in mmHg)
Measured: 3 months
Secondary outcomes (5)
Change in systemic and endothelial inflammation
Modification in the values of the special markers that were assessed: pentraxin-3, soluble endoglin (expressed in ng/mL)
Measured: 3 months
Normalization of metabolic profile
glucose, uric acid (expressed in mg/dL)
Measured: 3 months
Normalization of lipid profile
LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides (expressed in mg/dL)
Measured: 3 months
Modification in BMI
The weight (expressed in kg) and height (expressed in meters) will be combined to report BMI (body mass index expressed in bk/m^2)
Measured: 3 months
Modification of ADMA
The levels of asymmetric dimethylarginine (ADMA) will be assessed and expressed in mcg/L.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start1 Jun 2022
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Essential 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" Timisoara
- Sponsor type
- University, hospital or other
- Collaborators
- ASCAR Cardiology Clinic, Timisoara City Hospital
- Responsible party
- Principal investigator, Minodora Andor, ASCAR Cardiology Clinic, Timisoara City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05912322
- Sponsor's protocol ID
- 5DOC/1425/03.02.2020
- Acronym
- AROBLENDO
- Status last verified
- Jun 2023
- First submitted
- 1 Oct 2022
- Last updated
- 22 Jun 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jurikova T, Mlcek J, Skrovankova S, Sumczynski D, Sochor J, Hlavacova I, Snopek L, Orsavova J. Fruits of Black Chokeberry Aronia melanocarpa in the Prevention of Chronic Diseases. Molecules. 2017 Jun 7;22(6):944. doi: 10.3390/molecules22060944.
PubMed 28590446Buda V, Andor M, Antal D, Ardelean F, Pavel IZ, dehelean C, Soica C, Folescu R, Andrei F, Danciu C. Cardioprotective effects of cultivated black chokeberries (Aronia spp.): traditional uses, phytochemistry and therapeutic effects. Bioactive Compounds in Nutraceutical and Functional Food for Good Human Health. Ed:IntechOpen 2020, DOI: 10.5772/intechopen.92238, ISBN 978-1-83880-888-4
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comprehensive in Vivo Evaluation of Aronia Melanocarpa (Michx.) Elliott Bio Juice on Blood Pressure Levels and Endothelial Damage
- ClinicalTrials.gov ID
- NCT05912322
- Acronym / sponsor ID
- AROBLENDO / 5DOC/1425/03.02.2020
- Keywords
- black chokeberry, cardiovascular effects, essential arterial hypertension, endothelial dysfunction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University of Medicine and Pharmacy "Victor Babes" TimisoaraUniversity, hospital or other
- Collaborators
- ASCAR Cardiology Clinic, Timisoara City Hospital
- Study start
- 1 Jun 2022 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 22 Jun 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.
In Romania, the diseases of the circulatory system account for 59.3% of deaths, representing the main cause of morbidity and mortality.
Barriers of current pharmacological treatments materialized in side effects and limited actions on risk factors increase the necessity of finding more effective, multi-target and less toxic therapeutic strategies. Considering the well-known benefits, natural compounds represent a very important source for drug candidates.
The latest in vitro and in vivo studies on Aronia melanocarpa (Michx.) Elliott have highlighted its antioxidant, anti-inflammatory, anti-proliferative, anti-atherosclerotic, hypotensive, antiplatelet, lipid and glucose reduction properties, making it an excellent candidate for the prevention and treatment of cardiovascular and metabolic disorders.
The aim of this study is to comprehensive evaluate (in vivo) the Aronia melanocarpa bio juice, obtained from Romania on blood pressure levels and endothelial damage.
Detailed description
Patients at risk of developing hypertension (HTN) or suspicion of HTN will be invited for a visit in the Cardiology Clinic of Timisoara City Hospital. After performing the investigations for the suspicion of HTN in the Clinic, the diagnosis of HTN (>140/90mmHg) or pre-HTN (130-139/85-89mmHg) will be made after 24h monitorization, based on the results of Ambulatory Pressure Monitoring Device(ABPM). In function of the results and the patients' risk factors, a treatment strategy (pharmacological or non-pharmacological) will be implemented. Patients who fit the inclusion criteria will be asked to join the study. Study design: Prospective study of 3 months period. The included patients (≈ 100 patients) will be randomized (1:1) in two groups (one receiving 100ml black chokeberry juice (AMJ)/day and one control group, both under lifestyle changes), matched be age, sex and characteristics. The complete list of analysis and investigations will be performed at the inclusion of the study (T0), after 3 months (T3) of non-pharmacological treatment. Periodical phone calls (each 4 weeks) will be made by the clinical pharmacist to assess the health status, adherence, eventual problems of the treatment or difficulty to accomplish the targets. If any of the included patients will develop problems during the proposed treatment (ex: higher blood pressure levels) they will be excluded from the study and classical pharmacological treatment will be applied.
Investigations: familial and personal history of cardiovascular (CV) disease/renal disease and associated risk factors; smoking/drinking/substance abuse/dietary habits, blood pressure measurements, heart rate, weight, height, 12-lead electrocardiography, echocardiography (cardiac, vascular and abdominal), carotid intima-media thickness (IMT), flow mediated vasodilation (FMD), laboratory evaluation of venous blood samples (morning, fasting state >8h harvested on anticoagulant) and urine analysis. The complete blood count, electrolytes, hepatic, renal, lipid, triglycerides and glucose profile of venous blood sample and the urine analysis will be performed by routine laboratory analysis in the Cardiology Clinic. Quantification of several special markers of endothelial injury will be performed, such as: pentraxin-3, soluble endoglin (sEng), endothelin-1; asymmetric dimethylarginine (ADMA). The imagistic investigations will be performed by the same certified cardiologist.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Black chokeberry juice | Experimental | Dietary Supplement: Black chokeberry juice100ml black chokeberry juice/day |
| Control | No intervention | –Lifestyle changes. No juice |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- informed consent form signed,
- BP values: 130 - 159 / 85 - 99 mmHg (high normal BP and grade 1 HTN) at low-moderate CV risk (a calculated SCORE=1-5%)
- under no concomitant medications
Key exclusion criteria (12 listed)
- refusal to participate,
- BP ≥ 140/90mmHg with high CV risk,
- acute/chronic administration of any pharmacological treatment during the study period,
- other CV or cerebrovascular pathologies,
- congenital disorders,
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 |
|---|---|---|
| Black chokeberry juice100ml black chokeberry juice/day | Dietary supplement | Black chokeberry juice |
Primary outcome
Normalization of blood pressure levels
Time frame: 3 months
By inhibition of angiotensin I-converting enzyme (ACE). Measurements performed at the same hour/once a day (expressed in mmHg)
5 secondary outcomes
Change in systemic and endothelial inflammation
Time frame: 3 months
Normalization of metabolic profile
Time frame: 3 months
Normalization of lipid profile
Time frame: 3 months
Modification in BMI
Time frame: 3 months
Modification of ADMA
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Background: PubMed 28590446Jurikova T, Mlcek J, Skrovankova S, Sumczynski D, Sochor J, Hlavacova I, Snopek L, Orsavova J. Fruits of Black Chokeberry Aronia melanocarpa in the Prevention of Chronic Diseases. Molecules. 2017 Jun 7;22(6):944. doi: 10.3390/molecules22060944.
- BackgroundBuda V, Andor M, Antal D, Ardelean F, Pavel IZ, dehelean C, Soica C, Folescu R, Andrei F, Danciu C. Cardioprotective effects of cultivated black chokeberries (Aronia spp.): traditional uses, phytochemistry and therapeutic effects. Bioactive Compounds in Nutraceutical and Functional Food for Good Human Health. Ed:IntechOpen 2020, DOI: 10.5772/intechopen.92238, ISBN 978-1-83880-888-4
- European Commission Statistics (2018). Cardiovascular diseases statistics.Link provided by the sponsor.
- Individual participant dataSharing planned: No
Related trials for Essential Hypertension
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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 Black chokeberry juice in people with Essential Hypertension and Endothelial Dysfunction, run by University of Medicine and Pharmacy "Victor Babes" Timisoara at 1 site in Romania.
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 3 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 22 Jun 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 Romania. 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. 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?
Results are not available in the source record.
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?
Normalization of blood pressure levels (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05912322, which also lists 2 linked publications.
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 22 Jun 2023.