Cerebral Blood FlowNCT01540123
The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
A study testing Berry drink in people with Cerebral Blood Flow, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cerebral Blood Flow
- What is being tested?
- Berry drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Feb 2012to May 2013
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- none smokers
- aged between 18 and 35 years
Who cannot join
- History of neurological, vascular or psychiatric illness.
- Current diagnosis of depression and/or anxiety.
- History or current diagnosis of drug/alcohol abuse.
- Anaemia.
- Any heart disorder.
- Hypertension
Show all 21Show fewer
- Any respiratory disorder.
- Diabetes.
- Food intolerances/sensitivities.
- Phenylketonuria.
- Use tobacco products or have ceased in the last 6 months.
- Currently taking any prescribed, illicit or herbal drugs.
- Any known active infections.
- HIV antibody positive.
- Currently have, have ever had, or may be at risk of hepatitis.
- Have suffered from jaundice within the last year.
- Have haemophilia or any similar clotting disorder.
- History of head trauma
- History of migraines
- History of learning difficulties
- Any Issues with giving blood samples.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Brain, Performance and Nutrition Research Centre
Newcastle upon Tyne, Newcastle Upon-Tyne, NE18ST
About this study
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties.
Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life.
Read more
Fruit phytochemicals from other sources have been shown to mediate both peripheral and cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood flow via supplementation of berry polyphenols could therefore be a potential way to positively modulate human cognitive behavior. The link between acute increases in cerebral blood flow and increased cognition is currently a little weak but it could give a good platform for long term behavioral and health benefits via increased cerebral/peripheral blood flow and decreased MAO-B activity.
The aims of the study are therefore to investigate the impact of the berry extract on digital volume pulse, blood pressure and cerebral blood flow.
- Conditions
- Cerebral Blood Flow
- Being tested
- Berry drink, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Berry drinkDietary supplement
Cold pressed berry drink standardised to contain 500mg of berry polyphenols
ControlDietary supplement
Sugar matched control containing berry flavouring and no phytochemicals
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Sugar matched control containing no phytochemicals Receives: Dietary Supplement: Control |
| Berry drink standardised to contain 500mg of polyphenols | Experimental | Cold pressed berry drink standardised to contain 500mg of berry polyphenols Receives: Dietary Supplement: Berry drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Digital Volume Pulse
Measured: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Cerebral blood flow
Measured: Continuous measure from baseline to 100 minutes post dose
Blood platelet MAO-B activity
Measured: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Feb 2012 (estimated)
- Study startFeb 2012
- Primary completionMay 2013
- Study completionMay 2013
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 Cerebral Blood FlowStudies 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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Responsible party
- Principal investigator, Anthony Watson, Northumbria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01540123
- Sponsor's protocol ID
- 28AI3
- Status last verified
- Jun 2016
- First submitted
- 6 Feb 2012
- Last updated
- 21 Jun 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Watson AW, Scheepens A, Kennedy DO, Haskell-Ramsay CF. Effects of blackcurrant juice on pre-frontal cortical haemodynamics and cognition in healthy young adults. Nutr Neurosci. 2026 Jan;29(1):14-28. doi: 10.1080/1028415X.2025.2538062. Epub 2025 Sep 25.
PubMed 40999681
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Time Effects of a Berry Extract Upon Cerebral Blood Flow.
- ClinicalTrials.gov ID
- NCT01540123
- Acronym / sponsor ID
- 28AI3
- Conditions
- Cerebral Blood Flow
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- The New Zealand Institute of Plant and Food Research Ltd.
- Study start
- Feb 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 28 Feb 2012 (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.
Berry fruits are widely recognised as natural functional food products. They contain several different phytochemicals which have potential to modulate human health and wellbeing. There is however some debate regarding the mechanisms driving their health promoting properties.
Despite the wide health promoting properties of fruit extracts reported in the literature, considerable interest over the past decade has primarily been focused on their roles in reducing risk factors associated with cancer and heart disease. Consequently, there remains a paucity of actual scientific information on their role in modulating brain functions, such as mood, learning and memory, any decrements of which have very negative impacts on the quality of life.
Fruit phytochemicals from other sources have been shown to mediate both peripheral and cerebral blood flow. However, a modulation of cerebral blood flow has not been shown with berries as yet. Cerebral blood flow must be maintained to ensure a constant delivery of oxygen and glucose as well as the removal of waste products. The modulation of cerebral blood flow via supplementation of berry polyphenols could therefore be a potential way to positively modulate human cognitive behavior. The link between acute increases in cerebral blood flow and increased cognition is currently a little weak but it could give a good platform for long term behavioral and health benefits via increased cerebral/peripheral blood flow and decreased MAO-B activity.
The aims of the study are therefore to investigate the impact of the berry extract on digital volume pulse, blood pressure and cerebral blood flow.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Dietary Supplement: ControlSugar matched control containing no phytochemicals |
| Berry drink standardised to contain 500mg of polyphenols | Experimental | Dietary Supplement: Berry drinkCold pressed berry drink standardised to contain 500mg of berry polyphenols |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Healthy
- none smokers
- aged between 18 and 35 years
Key exclusion criteria (21 listed)
- History of neurological, vascular or psychiatric illness.
- Current diagnosis of depression and/or anxiety.
- History or current diagnosis of drug/alcohol abuse.
- Anaemia.
- Any heart disorder.
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 |
|---|---|---|
| Berry drinkCold pressed berry drink standardised to contain 500mg of berry polyphenols | Dietary supplement | Berry drink standardised to contain 500mg of polyphenols |
| ControlSugar matched control containing berry flavouring and no phytochemicals | Dietary supplement | Control |
Primary outcome
Digital Volume Pulse
Time frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
Cerebral blood flow
Time frame: Continuous measure from baseline to 100 minutes post dose
Blood platelet MAO-B activity
Time frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose
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 21 Jun 2016.
- Derived from this study: PubMed 40999681Watson AW, Scheepens A, Kennedy DO, Haskell-Ramsay CF. Effects of blackcurrant juice on pre-frontal cortical haemodynamics and cognition in healthy young adults. Nutr Neurosci. 2026 Jan;29(1):14-28. doi: 10.1080/1028415X.2025.2538062. Epub 2025 Sep 25.
- Related InfoLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Berry drink in people with Cerebral Blood Flow, run by Northumbria University 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 3 inclusion and 21 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 21 Jun 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?
Digital Volume Pulse (time frame: Change from baseline at 15, 30, 45, 60, 100, 120, 150, 180, 240 minutes and 24 hours post dose). The study lists 3 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 NCT01540123, 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 21 Jun 2016.