Clinical trial NCT05912322: Evaluation of Black Chokeberry Bio Juice on Blood Pressure Levels and Endothelial Damage
Official title: A Comprehensive in Vivo Evaluation of Aronia Melanocarpa (Michx.) Elliott Bio Juice on Blood Pressure Levels and Endothelial Damage
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Essential Hypertension
Endothelial Dysfunction
Inflammation
Keywords: black chokeberry
cardiovascular effects
essential arterial hypertension
endothelial dysfunction
Lead sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
Sponsor class: OTHER
Collaborators: name: ASCAR Cardiology Clinic, Timisoara City Hospital
First posted: 2023-06-22
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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 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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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,
* history/presence of peptic ulcer,
* acute/chronic inflammatory conditions,
* hypersensibility to black chokeberry juice,
* diabetes mellitus,
* gout,
* pregnancy/breast feeding mother

Primary outcomes:
measure: Normalization of blood pressure levels
timeFrame: 3 months
Secondary outcomes:
measure: Change in systemic and endothelial inflammation
timeFrame: 3 months
measure: Normalization of metabolic profile
timeFrame: 3 months
measure: Normalization of lipid profile
timeFrame: 3 months
measure: Modification in BMI
timeFrame: 3 months
measure: Modification of ADMA
timeFrame: 3 months
Other outcomes:
Locations:
city: Timisoara
country: Romania
facility: ASCAR Cardiology Clinic of Timisoara City Hospital
state: Timis
Study officials:
References:
citation: 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.
citation: Buda 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