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CompletedNCT02459756Updated Feb 9, 2016

Anthocyanin-rich Blackcurrant and Vascular Function

An interventional study of Beverage: Spray dried blackcurrant powder dissolved in water and Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) in Vascular Stiffness and Inflammation, sponsored by University of Reading. Completed at 1 site in United Kingdom. Open to participants aged 30 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-02-09.

Sponsored by University of Reading · Not applicable and Interventional

Phase
Not applicable
Study type
Interventional
Enrollment
23
Allocation
Randomized
Ages
30 Years to 55 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Vascular Stiffness
  • Inflammation

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Keywords

  • anthocyanins
  • bioavailability
03

In context

Inflammation

3,512 studies on the registry are indexed under Inflammation; 640 are open to participants now.

This study's enrollment of 23 is below the median of 50 across 2,491 interventional studies indexed under Inflammation.

Browse Inflammation studies →

Lead sponsor

University of Reading is the lead sponsor of 150 studies on the registry; 21 are open to participants now.

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Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
30 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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)
05

Study design

Phase
Not applicable
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
23 participants (actual)

Study arms

  • 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)

Interventions

  • OtherBeverage: Spray dried blackcurrant powder dissolved in water
  • OtherBeverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)
06

What researchers measure

Primary outcomes

  1. Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention

  2. Change from baseline in platelet function measured by agonist-induced platelet aggregation

    Time frame: Acute study: measured at baseline and 2 and 4 h post intervention

Secondary outcomes

  1. Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS

    Time frame: 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

  2. Change from baseline in vascular function measured by digital volume pulse (DVP)

    Time frame: Acute study: measured at baseline and 2, 4 and 6 h post intervention

  3. Change from baseline in blood pressure

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention

  4. Change from baseline in the concentration of nitric oxide in plasma measured by ozone-based chemiluminescence

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention

  5. 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

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention

  6. Change from baseline in platelet function (numbers of circulating micro particles by nano particle tracking analysis)

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)

  7. Metabonomics on urine and plasma samples measured by nuclear magnetic resonance spectroscopy

    Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)

07

Study locations

1 site
  • University of Reading
    Reading, RG6 6AP, United Kingdom
08

References and documents

Publications

  • Amini AM, Zhou R, Austermann K, Kralova D, Serra G, Ibrahim IS, Corona G, Bergillos-Meca T, Aboufarrag H, Kroon PA, Spencer JP, Yaqoob P. Acute Effects of an Anthocyanin-Rich Blackcurrant Beverage on Markers of Cardiovascular Disease Risk in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2025 Jul;155(7):2275-2289. doi: 10.1016/j.tjnut.2025.05.017. Epub 2025 May 23. PubMed 40414296 ↗
09

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jun 2015, a primary completion of Nov 2015 and a completion of Nov 2015. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
May 20, 2015
First posted
Jun 2, 2015
Start
Jun 2015
Primary completionActual
Nov 2015
CompletionActual
Nov 2015
Last update
Feb 9, 2016
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 9, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02459756
Lead sponsor
University of Reading
Collaborators
GlaxoSmithKline
Responsible party
Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN (Professor Parveen Yaqoob, University of Reading) — Principal investigator
First posted
Jun 2, 2015
Start date
Jun 2015
Primary completion
Nov 2015
Completion
Nov 2015
Last update
Feb 9, 2016

Study contacts

Parveen Yaqoob, DPhil
principal investigator · University of Reading

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2016. You cannot join it, but the record below documents what was studied.

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