The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk
NCT ID: NCT02800967
Last Updated: 2016-10-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
84 participants
INTERVENTIONAL
2014-01-31
2017-06-30
Brief Summary
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Detailed Description
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Recruited participants will be randomly assigned to one of three interventions (pure Aronia juice, Aronia beverage or placebo beverage) in the first phase and followed by cross-over in second and third phase. Two-week run-in period with low intake of polyphenols will precede the start of the intervention, ie. the first intervention phase. During each of three intervention periods (phases) subjects will consume 100 ml of each intervention product daily for 28 days, with 28 days of wash out period between different phases.
Blood and urine samples will be taken at baseline, before and after 28 days after each intervention period. Platelet analyses by flow cytometry, biochemical analyses of plasma samples, full blood count, blood pressure and anthropometric measurements will be performed at each study visit.
During the first study visit, regardless the allocation, blood samples will be taken before and 2h after the consumption of first 100 ml of intervention product (performed at the experimental site) and the analysis of markers of platelet function, biochemical parameters (glucose, triglycerides, and uric acid) and blood pressure will be assessed.
Subjects will be instructed to avoid rich-sources of anthocyanins and procyanidins during the whole study. Dietary habits will be assessed by food frequency questionnaire (FFQ) performed 2 times at the beginning and at the end of the study and 24h-recall performed at the beginning and after each wash out period.
Conditions
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Keywords
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Study Design
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RANDOMIZED
CROSSOVER
PREVENTION
QUADRUPLE
Study Groups
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Pure Aronia juice
Participants will consume 100 ml of pure Aronia juice per day for 28 days
Pure Aronia juice
Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml
Aronia juice-based beverage
Participants will consume 100 ml of Aronia juice-based beverage per day for 28 days.
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.
Placebo beverage
Participants will consume 100 ml of Placebo beverage per day for 28 days
Placebo beverage
A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions
Interventions
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Pure Aronia juice
Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml
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.
Placebo beverage
A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions
Eligibility Criteria
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Inclusion Criteria
* Central obesity ie. WC≥80 cm (women) and ≥94 cm (man) or
* Normal (systolic blood pressure (SBP): 120-129; diastolic blood pressure(DBP): 80-84) or high normal (SBP:130-139; DBP:85-89) blood pressure
Exclusion Criteria
* Diagnosed with CVD, history of stroke or CVD
* Diagnosis of type 2 diabetes mellitus on insulin therapy
* Very low or high blood pressure (\<90/50)
* Pregnant or have been pregnant in the last 12 months or on oral contraceptives
* Gastrointestinal diseases
* Diagnosed with a long-term illness requiring active treatment, e.g. cancer, thyroid, adrenal, pituitary diseases
* On regularly prescribed medication known to have a profound effect on CVD risk factors (including statins)
* Non-steroidal anti-inflammatory drugs including creams
* Sufferers of asthma and/or hay-fever
* Known allergy to any of investigated polyphenol-rich food
* Regularly using antacids and laxatives (at least once a week)
* Unwillingness to discontinue specific dietary (other than vitamins and minerals) or herbal supplements less than one month prior to the start of the study and for the duration of the study
* Unwillingness to restrict oily fish consumption to 2 portions or less per week less than one month prior to the start of the study and for the duration of the study
* Taking paracetamol for more than one day during the intervention period and unwillingness to continue with the study intervention for an additional 48 hours if paracetamol is taken
* Blood donation within 16 weeks of the first study sample and who intend to donate blood less than 16 weeks after the last study sample
* Those who receive or plan to receive any type of immunization during the study period and those who have received an immunization within 4 weeks of the start of the study
* Parallel participation in another research project which involves dietary intervention (e.g. taking vitamin supplements) or sampling of blood that may increase the total volume taken above 470 mL in a 4 month period
30 Years
50 Years
ALL
Yes
Sponsors
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Clinical Hospital Center Zemun
OTHER
University of Belgrade
OTHER
Responsible Party
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Maria Glibetic
Professor, PhD
Principal Investigators
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Maria Glibetic
Role: PRINCIPAL_INVESTIGATOR
University of Belgrade
Locations
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Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, , Serbia
Countries
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References
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Stojkovic L, Zec M, Zivkovic M, Bundalo M, Boskovic M, Glibetic M, Stankovic A. Polyphenol-Rich Aronia melanocarpa Juice Consumption Affects LINE-1 DNA Methylation in Peripheral Blood Leukocytes in Dyslipidemic Women. Front Nutr. 2021 Jun 17;8:689055. doi: 10.3389/fnut.2021.689055. eCollection 2021.
Other Identifiers
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Bacchus_AMARCord_2013
Identifier Type: -
Identifier Source: org_study_id