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

Study Overview
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Brief Summary
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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
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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.

Official Title
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A Comprehensive in Vivo Evaluation of Aronia Melanocarpa (Michx.) Elliott Bio Juice on Blood Pressure Levels and Endothelial Damage

Conditions
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Essential Hypertension, Endothelial Dysfunction, Inflammation

Intervention / Treatment
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* Dietary Supplement: Black chokeberry juice


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Black chokeberry juice<br>100ml black chokeberry juice/day | Dietary Supplement: Black chokeberry juice<br>* 100ml black chokeberry juice/day<br>|
| No Intervention: Control<br>Lifestyle changes. No juice | |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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black chokeberry, cardiovascular effects, essential arterial hypertension, endothelial dysfunction