NCT05912322

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jun 2022

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

October 1, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

June 22, 2023

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

June 22, 2023

Status Verified

June 1, 2023

Enrollment Period

1.1 years

First QC Date

October 1, 2022

Last Update Submit

June 12, 2023

Conditions

Essential HypertensionEndothelial DysfunctionInflammation

Keywords

black chokeberrycardiovascular effectsessential arterial hypertensionendothelial dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Change in systemic and endothelial inflammation

    3 months

  • Normalization of metabolic profile

    3 months

  • Normalization of lipid profile

    3 months

  • Modification in BMI

    3 months

  • Modification of ADMA

    3 months

Study Arms (2)

Black chokeberry juice

EXPERIMENTAL

100ml black chokeberry juice/day

Dietary Supplement: Black chokeberry juice

Control

NO INTERVENTION

Lifestyle changes. No juice

Interventions

Black chokeberry juiceDIETARY_SUPPLEMENT

100ml black chokeberry juice/day

Black chokeberry juice

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

ASCAR Cardiology Clinic of Timisoara City Hospital

Timișoara, Timiș County, 300337, Romania

Location

Related Publications (2)

  • 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.

    PMID: 28590446BACKGROUND

  • 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

    BACKGROUND

Related Links

MeSH Terms

Conditions

Essential HypertensionInflammation

Condition Hierarchy (Ancestors)

HypertensionVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Associate Professor

Study Record Dates

First Submitted

October 1, 2022

First Posted

June 22, 2023

Study Start

June 1, 2022

Primary Completion

June 30, 2023

Study Completion

September 30, 2023

Last Updated

June 22, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

RO(1)