Anthocyanin-rich Blackcurrant and Vascular Function

Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function

Regular consumption of fruits and vegetables may improve human health and reduce the risk of chronic diseases, such as heart disease, certain cancers and type 2 diabetes, but the active components and the underlying mechanisms are poorly understood. Berry fruits are abundant in anthocyanins and this study aims to test the hypothesis that ingestion of an anthocyanin-rich blackcurrant beverage will improve markers of cardiovascular health (health of blood vessels, inflammation and platelet function). Further, the study will investigate the anthocyanin bioavailability from the blackcurrant beverage.

Study Overview

• Status: Completed
• Conditions: Inflammation; Vascular Stiffness
• Intervention / Treatment: Other: Beverage: Spray dried blackcurrant powder dissolved in water; Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)

• Study Type: Interventional
• Enrollment (Actual): 23
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Reading, United Kingdom, RG6 6AP
    • University of Reading

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Aged 30-55 years
• Non-smoker
• BMI between 20 - 30 kg/m2
• Generally healthy as established by a 'health and lifestyle' questionnaire and a screening blood sample
• Blood pressure < 140/90mmHg
• Total cholesterol < 6.2 mmol/L
• Fasting glucose < 7.0 mmol/L

Exclusion Criteria:

• Diabetes mellitus
• Heart problems, stroke, vascular disease
• Inflammatory disease
• Kidney, liver, pancreas or gastrointestinal diseases
• Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions
• Asthma
• Allergies
• Smokers (social smokers who agree to abstain for 1 month before and during the study not excluded)
• Taking phytochemical, antioxidant or fish oil supplements (unless willing to stop for the study period)
• Taking aspirin > 2 times per month and unwilling to abstain from aspirin ingestion for 14 days prior each study visit
• History of alcohol misuse
• Consumption of alcohol >21 units (men) or >15 units (women)
• Vegans
• Intense aerobic exercise >20 min 3 x per week
• Participation in another clinical trial
• Antibiotics in previous 3 months before study
• Low haemoglobin levels
• Females who are pregnant, lactating, or if of reproductive age and not using a reliable form of contraception (including abstinence)

Study Plan

How is the study designed?

Design Details

• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Intervention; Spray dried blackcurrant powder dissolved in water	Other: Beverage: Spray dried blackcurrant powder dissolved in water
Placebo Comparator: Placebo; (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)	Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
Change from baseline in platelet function measured by agonist-induced platelet aggregation	Acute study: measured at baseline and 2 and 4 h post intervention

Secondary Outcome Measures

Outcome Measure	Time Frame
Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS	Acute study: plasma measured at baseline and 1, 2, 4, 6 and 24 h post intervention, urine measured at baseline and 1, 2, 4, 6 and 6-24 h post intervention
Change from baseline in vascular function measured by digital volume pulse (DVP)	Acute study: measured at baseline and 2, 4 and 6 h post intervention
Change from baseline in blood pressure	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
Change from baseline in the concentration of selected cytokines (TNF-a, IL-1b, IL-6, IL-8 and IL-10) in plasma measured using a cytometric bead array kit from BD Biosciences	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention
Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)
Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy	Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)

Collaborators and Investigators

• Sponsor: University of Reading
• Collaborators: GlaxoSmithKline
• Investigators: Principal Investigator: Parveen Yaqoob, DPhil, University of Reading

Study record dates

Study Major Dates

• Study Start: June 1, 2015
• Primary Completion (Actual): November 1, 2015
• Study Completion (Actual): November 1, 2015

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: June 1, 2015
• First Posted (Estimate): June 2, 2015

Study Record Updates

• Last Update Posted (Estimate): February 9, 2016
• Last Update Submitted That Met QC Criteria: February 8, 2016
• Last Verified: February 1, 2016

More Information

Terms related to this study

• Keywords: bioavailability; anthocyanins
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Vitamins; Anticoagulants; Antioxidants; Chelating Agents; Sequestering Agents; Calcium Chelating Agents; Ascorbic Acid; Citric Acid; Sodium Citrate
• Other Study ID Numbers: UREC 14/17