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The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk

NCT02800967 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2016-10-25

No results posted yet for this study

Summary

The existing scientific evidence from both in vitro and clinical trials supports the notion that polyphenols can modulate platelet function. Beyond being central players in haemostasis and thrombosis, platelets have crucial roles in the development of atherosclerosis, mediated through their interactions with monocytes and endothelial cells. Disturbed platelet function correlates with other risk factors, including hypertension and obesity, and the progression of cardiovascular diseases (CVD), postulating platelets as rational targets in CVD prevention. Thus, the effects of polyphenols on disturbed platelet function would contribute to their pleiotropic beneficial effects of on cardiovascular health. Aronia juice is a rich source of polyphenols including anthocyanins, procyanidins, phenolic acids and flavonols. However, there is no clinical evidence on the effects of aronia juice consumption on platelet function and related CVD factors. The purpose of this study is to investigate the effects of Aronia juice polyphenols on platelet function and other CVD risk factors in subjects with moderate CVD risk.

Conditions

Interventions

DIETARY_SUPPLEMENT

Pure Aronia juice

Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml

DIETARY_SUPPLEMENT

Aronia juice-based beverage

Aronia juice-based beverage with appx. polyphenols content of 250 mg gallic acid equivalents/100ml, obtained as a blend of ¼ vol. of pure Aronia juice and ¾ vol. of placebo beverage.

DIETARY_SUPPLEMENT

Placebo beverage

A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions

Sponsors & Collaborators

  • Clinical Hospital Center Zemun

    collaborator OTHER

  • University of Belgrade

    lead OTHER

Principal Investigators

  • Maria Glibetic · University of Belgrade

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
30 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-09-30
Completion
2017-06-30

Countries

  • Serbia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02800967 on ClinicalTrials.gov