The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk

NCT02800967 | Unknown DMC

• 1 other identifier: Bacchus_AMARCord_2013
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension; Overweight

Keywords

platelet activation; platelet aggregation; Aronia; flow cytometry; polyphenols; cardiovascular disease risk

Outcome Measures

Primary Outcomes (1)

• 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)

  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.

  Baseline, 2 hours and 4 weeks

• Changes in serum cholesterol levels between baseline and endpoint within the intervention group vs. control group.

  Baseline and 4 weeks

• Changes in serum triglycerides levels between baseline and endpoint within the intervention group vs. control group.

  Baseline, 2 hours and 4 weeks

• Changes in systolic and diastolic blood pressures between baseline and endpoint within the intervention group vs. control group.

  Baseline, 2 hours and 4 weeks

• Changes in body weight between baseline and 4 weeks within the intervention group vs. control group.

  Baseline and 4 weeks

Other Outcomes (6)

• Changes in parameters of liver function between baseline and endpoint

  Baseline and 4 weeks

• Changes in parameters of renal function between baseline and endpoint

  Baseline and 4 weeks

• Changes in uric acid, iron and oxLDL level between baseline and endpoint within the intervention group vs. control group.

  Baseline and 4 weeks

Study Arms (3)

Pure Aronia juice

ACTIVE COMPARATOR

Participants will consume 100 ml of pure Aronia juice per day for 28 days

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.

Dietary Supplement: Aronia juice-based beverage

Placebo beverage

PLACEBO COMPARATOR

Participants will consume 100 ml of Placebo beverage per day for 28 days

Dietary Supplement: Placebo beverage

Interventions

Pure Aronia juice DIETARY_SUPPLEMENT

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

Pure Aronia juice

Aronia juice-based beverage DIETARY_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.

Aronia juice-based beverage

Placebo beverage DIETARY_SUPPLEMENT

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

Placebo beverage

Eligibility Criteria

• Age: 30 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Belgrade: lead
• Clinical Hospital Center Zemun: collaborator

Study Sites (1)

Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade

Belgrade, 11000, Serbia

Location

Related Publications (1)

• 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.

  PMID: 34222308 DERIVED

MeSH Terms

Conditions

Hypertension; Overweight

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maria Glibetic

  University of Belgrade

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, PhD

Study Record Dates

• First Submitted: June 3, 2016
• First Posted: June 15, 2016
• Study Start: January 1, 2014
• Primary Completion: September 1, 2016
• Study Completion: June 1, 2017
• Last Updated: October 25, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)