Evaluation of Black Chokeberry Bio Juice on Blood Pressure Levels and Endothelial Damage (AROBLENDO)

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.

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Inflammation; Essential Hypertension; Endothelial Dysfunction
• Intervention / Treatment: Dietary supplement: Black chokeberry juice

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 Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Romania
  • Timis
    • Timisoara, Timis, Romania, 300337
      • ASCAR Cardiology Clinic of Timisoara City Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Black chokeberry juice; 100ml black chokeberry juice/day	Dietary supplement: Black chokeberry juice; 100ml black chokeberry juice/day
No Intervention: Control; Lifestyle changes. No juice

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	3 months
Normalization of metabolic profile	glucose, uric acid (expressed in mg/dL)	3 months
Normalization of lipid profile	LDL-cholesterol, HDL-cholesterol, total cholesterol, triglycerides (expressed in mg/dL)	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)	3 months
Modification of ADMA	The levels of asymmetric dimethylarginine (ADMA) will be assessed and expressed in mcg/L.	3 months

Collaborators and Investigators

• Sponsor: University of Medicine and Pharmacy "Victor Babes" Timisoara
• Collaborators: ASCAR Cardiology Clinic, Timisoara City Hospital

Publications and helpful links

General 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.
• 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

Helpful Links

• European Commission Statistics (2018). Cardiovascular diseases statistics.

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2022
• Primary Completion (Estimated): June 30, 2023
• Study Completion (Estimated): September 30, 2023

Study Registration Dates

• First Submitted: October 1, 2022
• First Submitted That Met QC Criteria: June 12, 2023
• First Posted (Actual): June 22, 2023

Study Record Updates

• Last Update Posted (Actual): June 22, 2023
• Last Update Submitted That Met QC Criteria: June 12, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: endothelial dysfunction; cardiovascular effects; essential arterial hypertension; black chokeberry
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Hypertension; Inflammation; Essential Hypertension
• Other Study ID Numbers: 5DOC/1425/03.02.2020

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No