The Effects of Aronia Juice Polyphenols on Cardiovascular Disease Risk

Hypertension Clinical Trial

— AMARCord  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02800967
• Other study ID #: Bacchus_AMARCord_2013
• Status: Active, not recruiting
• Phase: N/A
• First received: June 3, 2016
• Last updated: October 24, 2016
• Start date: January 2014
• Est. completion date: June 2017

Study information

• Verified date: October 2016
• Source: University of Belgrade
• Contact: n/a
• Is FDA regulated: No
• Health authority: Serbia: Ethics Committee
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 84
• Est. completion date: June 2017
• Est. primary completion date: September 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 30 Years to 50 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Hypertension
• Overweight

Intervention

Dietary Supplement:
• 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

Locations

Country	Name	City	State
Serbia	Centre of Research Excellence in Nutrition and Metabolism, Institute for Medical Research, University of Belgrade	Belgrade

Sponsors (2)

Lead Sponsor	Collaborator
University of Belgrade	Clinical Hospital Center Zemun

Country where clinical trial is conducted

Serbia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Changes in parameters of liver function between baseline and endpoint	Aspartate transferase, alanine transferase , direct bilirubin, total bilirubin, gamma-glutamyl transferase , lactate dehydrogenase levels in 12h-fasting serum samples analysed by biochemical analyser	Baseline and 4 weeks	Yes
Other	Changes in parameters of renal function between baseline and endpoint	Urea and creatinine levels in 12h-fasting serum samples analysed by biochemical analyser	Baseline and 4 weeks	Yes
Other	Changes in uric acid, iron and oxLDL level between baseline and endpoint within the intervention group vs. control group.	In 12h-fasting serum samples analysed by biochemical analyser	Baseline and 4 weeks	No
Other	Changes in full blood count between baseline and endpoint		Baseline and 4 weeks	Yes
Other	Changes in total caloric intake and intake of total polyphenols	Both caloric intake and intake of polyphenols will be assessed by standardized food-frequency questionnaire and 24-recall at baseline and after each wash—out period, based on data from Serbian Food Composition database. The agreements between two methods will also be assessed.	Baseline and 4 weeks	No
Other	Changes in urine levels of major polyphenol metabolites between baseline and endpoint	Measured in spot urine of total morning void by liquid chromatography	Baseline, 2h and 4 weeks	No
Primary	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	No
Secondary	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.	Baseline, 2 hours and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline, 2 hours and 4 weeks	No
Secondary	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	Baseline, 2 hours and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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.	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No
Secondary	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	Baseline and 4 weeks	No