Healthy Adults.NCT01289860
Investigating the Acute Effects of Flavonoids in Blueberries on Cognitive Function.
A study testing Flavonoids in people with Healthy Adults., run by University of Reading at 1 site in United Kingdom.
Trial summary
This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Adults.
- What is being tested?
- Flavonoids
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 47 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2009to Jan 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No medical conditions
- Not taking any medication or supplements (or willing to stop taking supplements for duration of study)
- Not lactose intolerant
- Willing to give blood and urine samples
- Not partaking in frequent vigorous exercise
- Not suffering from or history of depression
Who cannot join
- On blood pressure medication, taking Aspirin or other blood thinning medication
- BMI > 30
- Cholesterol > 6
- Diabetes or other serious medical condition
- Lactose intolerant
- Any learning difficulty e.g. dyslexia
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.
This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. These outcome measures were taken at 2 and 5 hours post drink.
It was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. It was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a control drink.
Read the detailed description
The control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.
Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production through the ERK-CREB-BDNF pathway.
Flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.
- Conditions
- Healthy Adults.
- Being tested
- Flavonoids, Control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FlavonoidsDietary supplement
Also called Anthocyanidins, flavanols, flavonols.
475g of anthocyanidins in 300ml of blueberry drink.
ControlDietary supplement
29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid.
| Study group | Role | What they receive |
|---|---|---|
| Blueberry drink | Active comparator | 30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk Receives: Dietary Supplement: Flavonoids |
| Control drink | Placebo comparator | 29g of powder consisting of sugars and vitamin C, values of which were matched to that of the blueberry drink, with 1 g of citric acid to match for taste. Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Extensive cognitive test battery including tasks measuring executive function such as updating, and memory tests such as free recall.
Measured: pre drink, 2 hours and 5 hours post drink
Secondary outcomes (3)
Bioavailability and pharmacology
Flavonoid and BDNF levels in plasma and urine samples.
Measured: Pre drink and 1 hour post drink
Vascular Reactivity
Measurements taken using Digital volume pulse equipment. Blood pressure also recorded.
Measured: Pre and 1 hour post drink
Neuronal effects
Using fMRI to determine whether flavonoid supplementation leads to greater activation in brain regions associated with the cognitive abilities tested and to calculate cerebral blood flow before and after the blueberry compared to the control drink.
Measured: Pre and 1 hours post drink
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2011 (estimated)
- Study startMay 2009
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Adults.Studies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, PhD, Principal investigator, University of ReadingLaurie T Butler, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01289860
- Sponsor's protocol ID
- UReading_2010_01
- Status last verified
- Feb 2013
- First submitted
- 3 Feb 2011
- Last updated
- 21 Feb 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Controlled, Cross-over, Acute Intervention Study Investigating the Cognitive and Neuronal Effects of Flavonoids in Blueberries.
- ClinicalTrials.gov ID
- NCT01289860
- Acronym / sponsor ID
- UReading_2010_01
- Conditions
- Healthy Adults.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 4 Feb 2011 (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.
This study was a controlled, cross-over, acute flavonoid intervention trial with younger and older adults. Subjects consumed a blueberry beverage during one visit and a control beverage on another. Cognitive function pre drink was assessed, blood and urine samples were taken as well as blood pressure and a measure of vascular reactivity. These outcome measures were taken at 2 and 5 hours post drink.
It was predicted that the flavonoids in the blueberry drink would lead to improved performance on the cognitive tests and vascular reactivity measure compared to following the control drink. It was thought this could be due to increased vaso-dilation and improving blood flow to the brain which was investigated in an extension to the project where a sample of individuals underwent brain imaging in an MRI scanner pre and post a blueberry and a control drink.
Detailed description
The control drink was matched to the blueberry drink for other bioactive compounds which may have affected cognition, specifically sugars and vitamin C. Volunteers were healthy, not on any medication, without high blood pressure, high cholesterol, high BMI, diabetes or other medical conditions. Older adults were aged 61-75 years and younger adults 18-26 years.
Blood and urine samples will be analysed for flavonoid levels and Brain Derived Neurotrophic Factor, a biomarker of memory and learning, flavonoids may lead to increased BDNF production through the ERK-CREB-BDNF pathway.
Flavonoids may also increase nitric oxide production and improve the flexibility of the blood vessels hence the measure of vascular reactivity using the Digital Volume Pulse machine. This can lead to increased vaso-dilation and blood flow to the brain, therefore an fMRI study was carried out the investigate this using arterial spin labeling following acute blueberry supplementation compared to a control drink.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blueberry drink | Active comparator | Dietary Supplement: Flavonoids30g of blueberry powder (equivalent to 200g fresh blueberries) and 300ml of semi-skimmed milk |
| Control drink | Placebo comparator | Dietary Supplement: Control29g of powder consisting of sugars and vitamin C, values of which were matched to that of the blueberry drink, with 1 g of citric acid to match for taste. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- No medical conditions
- Not taking any medication or supplements (or willing to stop taking supplements for duration of study)
- Not lactose intolerant
- Willing to give blood and urine samples
- Not partaking in frequent vigorous exercise
Key exclusion criteria (6 listed)
- On blood pressure medication, taking Aspirin or other blood thinning medication
- BMI > 30
- Cholesterol > 6
- Diabetes or other serious medical condition
- Lactose intolerant
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 |
|---|---|---|
| FlavonoidsAlso: Anthocyanidins, flavanols, flavonols.475g of anthocyanidins in 300ml of blueberry drink. | Dietary supplement | Blueberry drink |
| Control29g powder: sugars (glucose, sucrose, fructose), vitamin C and citric acid. | Dietary supplement | Control drink |
Primary outcome
Cognitive function
Time frame: pre drink, 2 hours and 5 hours post drink
Extensive cognitive test battery including tasks measuring executive function such as updating, and memory tests such as free recall.
3 secondary outcomes
Bioavailability and pharmacology
Time frame: Pre drink and 1 hour post drink
Vascular Reactivity
Time frame: Pre and 1 hour post drink
Neuronal effects
Time frame: Pre and 1 hours post drink
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 Feb 2013.
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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.
Jeremy PE Spencer, PhD principal investigator
University of Reading
Laurie T Butler, PhD 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 Flavonoids in people with Healthy Adults., 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 6 inclusion and 6 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 Feb 2013. 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?
Cognitive function (time frame: pre drink, 2 hours and 5 hours post drink). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2013.