Vascular StiffnessNCT02459756
Anthocyanin-rich Blackcurrant and Vascular Function
A study testing Beverage: Spray dried blackcurrant powder dissolved in water in people with Vascular Stiffness and Inflammation, run by University of Reading at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness, Inflammation
- What is being tested?
- Beverage: Spray dried blackcurrant powder dissolved in water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 23 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2015to Nov 2015
- 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 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- Diabetes mellitus
- Heart problems, stroke, vascular disease
- Inflammatory disease
- Kidney, liver, pancreas or gastrointestinal diseases
- Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions
- Asthma
Show all 18Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Vascular Stiffness, Inflammation
- Being tested
- Beverage: Spray dried blackcurrant powder dissolved in water, Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)
- Keywords
- anthocyanins, bioavailability
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Beverage: Spray dried blackcurrant powder dissolved in waterOther
Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)Other
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Active comparator | Spray dried blackcurrant powder dissolved in water Receives: Other: Beverage: Spray dried blackcurrant powder dissolved in water |
| Placebo | Placebo comparator | (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) Receives: Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in vascular reactivity measured by flow-mediated dilatation (FMD)
Measured: 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
Measured: Acute study: measured at baseline and 2 and 4 h post intervention
Secondary outcomes (7)
Change from baseline in the concentration of polyphenols and their metabolites and degradants in blood and urine samples measured by HPLC-MS/MS
Measured: 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)
Measured: Acute study: measured at baseline and 2, 4 and 6 h post intervention
Change from baseline in blood pressure
Measured: 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
Measured: 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
Measured: 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)
Measured: 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
Measured: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2015 (estimated)
- Study startJun 2015
- Primary completionNov 2015
- Study completionNov 2015
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 Vascular StiffnessStudies 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- GlaxoSmithKline
- Responsible party
- Principal investigator, Professor Parveen Yaqoob, MA, DPhil, RNutr, FAfN, University of Reading
- Investigators
- Parveen Yaqoob, DPhil, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02459756
- Sponsor's protocol ID
- UREC 14/17
- Status last verified
- Feb 2016
- First submitted
- 20 May 2015
- Last updated
- 9 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
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
Study at a glance
From the registry record, last updated by the sponsor on 9 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of an Anthocyanin-rich Blackcurrant Beverage on Cardiovascular Function
- ClinicalTrials.gov ID
- NCT02459756
- Acronym / sponsor ID
- UREC 14/17
- Conditions
- Vascular Stiffness, Inflammation
- Keywords
- anthocyanins, bioavailability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- GlaxoSmithKline
- Study start
- Jun 2015
- Primary completion
- Nov 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 2 Jun 2015 (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.
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 design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Active comparator | Other: Beverage: Spray dried blackcurrant powder dissolved in waterSpray dried blackcurrant powder dissolved in water |
| Placebo | Placebo comparator | Other: Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water)(sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- Diabetes mellitus
- Heart problems, stroke, vascular disease
- Inflammatory disease
- Kidney, liver, pancreas or gastrointestinal diseases
- Medication for hyperlipidaemia, hypertension, hypercoagulation, inflammatory conditions
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 |
|---|---|---|
| Beverage: Spray dried blackcurrant powder dissolved in water | Other | Intervention |
| Beverage: Placebo (sucrose, glucose, fructose, maltodextrin, malic acid, citric acid, vitamin C, artificial blackcurrant flavouring and low-nitrate water) | Other | Placebo |
Primary outcome
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
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
7 secondary outcomes
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
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
Change from baseline in blood pressure
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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
Time frame: Acute study: measured at baseline and 1, 2, 4 and 6 h post intervention (urine metabonomics additionally 6-24h)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Feb 2016.
- Derived from this study: PubMed 40414296Amini 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.
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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.
Parveen Yaqoob, DPhil principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Beverage: Spray dried blackcurrant powder dissolved in water in people with Vascular Stiffness and Inflammation, run by University of Reading at 1 site in United Kingdom.
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 7 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: finished, as of the sponsor's last update on 9 Feb 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 United Kingdom. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
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). The study lists 2 primary outcomes in all. 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 NCT02459756, 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 9 Feb 2016.