HypertensionAMARCordNCT02800967
The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk
A study testing Pure Aronia juice and Aronia juice-based beverage in people with Hypertension and Overweight, run by University of Belgrade at 1 site in Serbia.
Trial 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… Read more about this study
- Who is it for?
- Ages 30 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Overweight
- What is being tested?
- Pure Aronia juice and Aronia juice-based beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteSerbia
- Study dates
- Jan 2014to Jun 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI: 25-30 or
- 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
Who cannot join
- Smokers
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Serbia1 site
Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade
Belgrade, 11000
About this study
Official title: Investigation of Beneficial Effects of Aronia Juice (Aronia Melanocarpa) and Dietary Polyphenols on the Activity of Thrombocytes as Well as Other Risk Factors Causing Cardio-vascular Diseases
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.
Read the detailed description
To investigate the effect of Aronia (Aronia melanocarpa L.) juice polyphenols on platelet function and other CVD risk factors a three-arm, crossover design, randomized, double-blind placebo-controlled clinical trial will be performed in apparently healthy subjects at moderate CVD risk.
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
- Hypertension, Overweight
- Being tested
- Pure Aronia juice, Aronia juice-based beverage, Placebo beverage
- Keywords
- platelet activation, platelet aggregation, Aronia, flow cytometry, polyphenols, cardiovascular disease risk
- Medical subject headings
- Hypertension, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pure Aronia juiceDietary supplement
Pure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml
Aronia juice-based beverageDietary supplement
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 beverageDietary supplement
A polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions
| Study group | Role | What they receive |
|---|---|---|
| Pure Aronia juice | Active comparator | Participants will consume 100 ml of pure Aronia juice per day for 28 days Receives: Dietary Supplement: Pure Aronia juice |
| Aronia juice-based beverage | Active comparator | Participants will consume 100 ml of Aronia juice-based beverage per day for 28 days. Receives: Dietary Supplement: Aronia juice-based beverage |
| Placebo beverage | Placebo comparator | Participants will consume 100 ml of Placebo beverage per day for 28 days Receives: Dietary Supplement: Placebo beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the percentage of P-selectin and glycoprotein IIbIIIa (GPIIbIIIa) positive platelets, percentage of platelet-monocyte and platelet-neutrophil aggregates, between baseline and endpoint within the intervention group vs. control group.
Percentage of P-selectin and GPIIbIIIa positive platelets evaluated in total number of 20000 platelets, percentage of platelet-monocyte aggregates in 1000 monocytes and percentage of platelet-neutrophil aggregates in total 20000 neutrophils, all by flow cytometry, in non-treated blood samples and after ex vivo treatment of the whole blood with adenosine-diphosphate (0.5 μM and 20 μM)
Measured: Baseline, 2 hours and 4 weeks
Secondary outcomes (10)
Changes in serum glucose levels between baseline and endpoint within the intervention group vs. control group.
In 12h-fasting and 2h postprandial serum samples analysed by biochemical analyser.
Measured: Baseline, 2 hours and 4 weeks
Changes in serum cholesterol levels between baseline and endpoint within the intervention group vs. control group.
Total cholesterol, LDL-cholesterol and HDL-cholesterol levels in 12h-fasting serum samples analysed by biochemical analyser
Measured: Baseline and 4 weeks
Changes in serum triglycerides levels between baseline and endpoint within the intervention group vs. control group.
In 12h-fasting and 2h postprandial serum samples analysed by biochemical analyser
Measured: Baseline, 2 hours and 4 weeks
Changes in systolic and diastolic blood pressures between baseline and endpoint within the intervention group vs. control group.
Mean of 3 x 2 consecutive office measurements performed within 30 min at each time point with professional OMRON device
Measured: Baseline, 2 hours and 4 weeks
Changes in body weight between baseline and 4 weeks within the intervention group vs. control group.
Body weight will be measured by bio-impedance scale
Measured: Baseline and 4 weeks
Changes in waist circumference between baseline and 4 weeks within the intervention group vs. control group.
Waist circumference will be measured by professional tape, according to the guidelines
Measured: Baseline and 4 weeks
Changes in body mass index between baseline and 4 weeks within the intervention group vs. control group.
Body mass index will be calculated based on values obtained as body weight in kilograms divided by height in meters squared.
Measured: Baseline and 4 weeks
Changes in the percentage of body fat between baseline and 4 weeks within the intervention group vs. control group
Body fat as percentage of total weight measured by bio-impedance instrument
Measured: Baseline and 4 weeks
Changes in the percentage of body water between baseline and 4 weeks within the intervention group vs. control group
Body water as percentage of total weight measured by bio-impedance instrument
Measured: Baseline and 4 weeks
Changes in total body muscle mass between baseline and 4 weeks within the intervention group vs. control group
Percentages of total body muscle mass in kilograms will be measured by bio-impedance instrument
Measured: Baseline and 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionSep 2016
- Study completionJun 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Belgrade
- Sponsor type
- University, hospital or other
- Collaborators
- Clinical Hospital Center Zemun
- Responsible party
- Principal investigator, Maria Glibetic, University of Belgrade
- Investigators
- Maria Glibetic, Principal investigator, University of Belgrade
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02800967
- Sponsor's protocol ID
- Bacchus_AMARCord_2013
- Acronym
- AMARCord
- Status last verified
- Oct 2016
- First submitted
- 3 Jun 2016
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 34222308
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Beneficial Effects of Aronia Juice (Aronia Melanocarpa) and Dietary Polyphenols on the Activity of Thrombocytes as Well as Other Risk Factors Causing Cardio-vascular Diseases
- ClinicalTrials.gov ID
- NCT02800967
- Acronym / sponsor ID
- AMARCord / Bacchus_AMARCord_2013
- Conditions
- Hypertension, Overweight
- Keywords
- platelet activation, platelet aggregation, Aronia, flow cytometry, polyphenols, cardiovascular disease risk
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University of BelgradeUniversity, hospital or other
- Collaborators
- Clinical Hospital Center Zemun
- Study start
- Jan 2014
- Primary completion
- Sep 2016 (actual)
- Study completion
- Jun 2017 (estimated)
- First posted
- 15 Jun 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To investigate the effect of Aronia (Aronia melanocarpa L.) juice polyphenols on platelet function and other CVD risk factors a three-arm, crossover design, randomized, double-blind placebo-controlled clinical trial will be performed in apparently healthy subjects at moderate CVD risk.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Pure Aronia juice | Active comparator | Dietary Supplement: Pure Aronia juiceParticipants will consume 100 ml of pure Aronia juice per day for 28 days |
| Aronia juice-based beverage | Active comparator | Dietary Supplement: Aronia juice-based beverageParticipants will consume 100 ml of Aronia juice-based beverage per day for 28 days. |
| Placebo beverage | Placebo comparator | Dietary Supplement: Placebo beverageParticipants will consume 100 ml of Placebo beverage per day for 28 days |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- BMI: 25-30 or
- 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
Key exclusion criteria (18 listed)
- Smokers
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pure Aronia juicePure Aronia juice with appx. polyphenols content of 1000 mg gallic acid equivalents/100ml | Dietary supplement | Pure Aronia juice |
| Aronia juice-based beverageAronia 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 | Aronia juice-based beverage |
| Placebo beverageA polyphenol-free formulation with matched nutrient composition (sugars, vitamins, minerals) and similar sensory characteristics to active interventions | Dietary supplement | Placebo beverage |
Primary outcome
Changes in the percentage of P-selectin and glycoprotein IIbIIIa (GPIIbIIIa) positive platelets, percentage of platelet-monocyte and platelet-neutrophil aggregates, between baseline and endpoint within the intervention group vs. control group.
Time frame: Baseline, 2 hours and 4 weeks
Percentage of P-selectin and GPIIbIIIa positive platelets evaluated in total number of 20000 platelets, percentage of platelet-monocyte aggregates in 1000 monocytes and percentage of platelet-neutrophil aggregates in total 20000 neutrophils, all by flow cytometry, in non-treated blood samples and after ex vivo treatment of the whole blood with adenosine-diphosphate (0.5 μM and 20 μM)
10 secondary outcomes
Changes in serum glucose levels between baseline and endpoint within the intervention group vs. control group.
Time frame: Baseline, 2 hours and 4 weeks
Changes in serum cholesterol levels between baseline and endpoint within the intervention group vs. control group.
Time frame: Baseline and 4 weeks
Changes in serum triglycerides levels between baseline and endpoint within the intervention group vs. control group.
Time frame: Baseline, 2 hours and 4 weeks
Changes in systolic and diastolic blood pressures between baseline and endpoint within the intervention group vs. control group.
Time frame: Baseline, 2 hours and 4 weeks
Changes in body weight between baseline and 4 weeks within the intervention group vs. control group.
Time frame: Baseline and 4 weeks
Changes in waist circumference between baseline and 4 weeks within the intervention group vs. control group.
Time frame: Baseline and 4 weeks
Changes in body mass index between baseline and 4 weeks within the intervention group vs. control group.
Time frame: Baseline and 4 weeks
Changes in the percentage of body fat between baseline and 4 weeks within the intervention group vs. control group
Time frame: Baseline and 4 weeks
Changes in the percentage of body water between baseline and 4 weeks within the intervention group vs. control group
Time frame: Baseline and 4 weeks
Changes in total body muscle mass between baseline and 4 weeks within the intervention group vs. control group
Time frame: Baseline and 4 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Derived from this study: PubMed 34222308Stojkovic 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.
- Individual participant dataSharing planned: No
Related trials for Hypertension
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maria Glibetic principal investigator
University of Belgrade
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pure Aronia juice and Aronia juice-based beverage in people with Hypertension and Overweight, run by University of Belgrade at 1 site in Serbia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Serbia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in the percentage of P-selectin and glycoprotein IIbIIIa (GPIIbIIIa) positive platelets, percentage of platelet-monocyte and platelet-neutrophil aggregates, between baseline and endpoint within the intervention group vs. control group. (time frame: Baseline, 2 hours and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02800967, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.