HealthyBluLifeNCT03592966
Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognition in Healthy Individuals.
A study testing Wild Blueberry Powder in people with Healthy, run by King's College London at 1 site in United Kingdom.
Trial summary
This study aims to determine the effect of blueberry (poly)phenol vs placebo on vascular function and cognitive performance with an insight into cerebral blood flow velocity changes, across all ages of the general healthy population. Read more about this study
- Who is it for?
- Ages 8 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Wild Blueberry Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 92 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jun 2018to 18 May 2021
- 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 8 to 80 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Healthy men and women aged 8-80 years old
- Are able to understand the nature of the study
- Able and willing to give signed written informed consent with the addition of a parent/carer for the consent of children under 16.
- Are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
Who cannot join
- Manifest cardiovascular diseases including coronary artery disease, cerebrovascular disease and peripheral artery disease.
- Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
- Obese participants, defined as BMI superior or equal to 30.
- Diabetes mellitus and metabolic syndrome.
- Acute inflammation, terminal renal failure or malignancies.
- Abnormal heart rhythm (lower or higher than 60-100 bpm).
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- Allergies to berries or another significant food allergy.
- Subjects under medication or on vitamin/dietary supplements (within 2 weeks of baseline).
- Subjects who have lost more than 10% of their weight in the past 6 months or are currently on a diet.
- Subjects who reported participant in another study within one month before the study starts.
- Subjects who smoke cigarettes.
- MCI or dyslexic or unable to complete the cognitive function tasks for any reason such as visual impairments.
- Subjects who require chronic antimicrobial or antiviral treatment.
- Subjects with unstable psychological condition.
- Subjects with history of cancer, myocardial infarction, cerebrovascular incident.
- Any reason or condition that in the judgment of the clinical investigator(s) may put the subject at unacceptable risk or that may preclude the subject from understanding or complying with the study's requirements.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomised, Double-blind, Placebo Controlled, Crossover Trial Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance in Healthy Individuals Across the Life Course.
This study aims to determine the effect of blueberry (poly)phenol vs placebo on vascular function and cognitive performance with an insight into cerebral blood flow velocity changes, across all ages of the general healthy population.
Read the detailed description
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. Blueberries are rich in anthocyanins, a subclass of flavonoids that have been widely linked to health benefits, particularly improvements in endothelial function. Research have previously shown that blueberries improve executive functioning and memory in both healthy adults and children. These improvements were seen within 2-5 hours post-consumption of blueberries, a time-course that positively correlates with improvements in vascular function (measured as flow-mediated dilation). This indicates that increases in blood flow may influence improvements in cognitive performance. To date no study has investigated whether blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, investigators aim to directly link wild blueberry consumption with increased vascular and cerebral blood flow and positive cognitive outcomes in healthy individuals through the life course, between the ages of 8 and 80 years old. Investigators will use a large group of healthy subjects representative of the general public over a wide age range in males and females to evaluate the generalisability of the health benefits of blueberry consumption.
- Conditions
- Healthy
- Being tested
- Wild Blueberry Powder, Placebo
- Keywords
- (Poly)phenols, Blueberries, Anthocyanins, Cognitive function, Vascular function
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild Blueberry PowderDietary supplement
Freeze-dried whole fruit blueberry drink.
PlaceboDietary supplement
Freeze-dried placebo powder
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Freeze-dried placebo powder Receives: Dietary Supplement: Placebo |
| Wild Blueberry powder | Active comparator | Freeze-dried whole fruit blueberry drink. Receives: Dietary Supplement: Wild Blueberry Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cognitive function
Cognitive testing involves the participant conducting tasks administered on a tablet-style laptop. The participants will be conducting these tasks whilst cerebral blood flow measurements are taking place. The cognitive testing battery will consist of 4 tasks including a mood assessment (PANAS).
Measured: Change from baseline cognitive function at 2 hours post-consumption
Endothelial Function
Flow mediated dilation (FMD)
Measured: Change from baseline endothelial function at 2 hours post-consumption
Secondary outcomes (2)
Cerebral blood flow (CBF)
Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD)
Measured: Change of baseline cerebral blood flow at 2 hours post consumption
Blood pressure
Automated clinical digital sphygmomanometer
Measured: Change from baseline systolic blood pressure at 2 hours post consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start1 Jun 2018
- Primary completion1 Oct 2020
- Study completion18 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by King's College LondonThe sponsor's other registered studies.
- 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
- Model description
- Randomized, cross-over, double-blind, placebo-controlled study.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Reading
- Responsible party
- Principal investigator, Dr Ana Rodriguez-Mateos, King's College London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592966
- Sponsor's protocol ID
- BLULIFE
- Acronym
- BluLife
- Status last verified
- May 2021
- First submitted
- 6 Apr 2018
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo Controlled, Crossover Trial Investigating the Acute Effects of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance in Healthy Individuals Across the Life Course.
- ClinicalTrials.gov ID
- NCT03592966
- Acronym / sponsor ID
- BluLife / BLULIFE
- Conditions
- Healthy
- Keywords
- (Poly)phenols, Blueberries, Anthocyanins, Cognitive function, Vascular function
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- 1 Jun 2018 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 18 May 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- 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 aims to determine the effect of blueberry (poly)phenol vs placebo on vascular function and cognitive performance with an insight into cerebral blood flow velocity changes, across all ages of the general healthy population.
Detailed description
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. Blueberries are rich in anthocyanins, a subclass of flavonoids that have been widely linked to health benefits, particularly improvements in endothelial function. Research have previously shown that blueberries improve executive functioning and memory in both healthy adults and children. These improvements were seen within 2-5 hours post-consumption of blueberries, a time-course that positively correlates with improvements in vascular function (measured as flow-mediated dilation). This indicates that increases in blood flow may influence improvements in cognitive performance. To date no study has investigated whether blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, investigators aim to directly link wild blueberry consumption with increased vascular and cerebral blood flow and positive cognitive outcomes in healthy individuals through the life course, between the ages of 8 and 80 years old. Investigators will use a large group of healthy subjects representative of the general public over a wide age range in males and females to evaluate the generalisability of the health benefits of blueberry consumption.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized, cross-over, double-blind, placebo-controlled study.
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboFreeze-dried placebo powder |
| Wild Blueberry powder | Active comparator | Dietary Supplement: Wild Blueberry PowderFreeze-dried whole fruit blueberry drink. |
Who may qualify
- Ages
- 8 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy men and women aged 8-80 years old
- Are able to understand the nature of the study
- Able and willing to give signed written informed consent with the addition of a parent/carer for the consent of children under 16.
- Are willing to maintain their normal eating/drinking habits and exercise habits to avoid changes in body weight over the duration of the study.
Key exclusion criteria (16 listed)
- Manifest cardiovascular diseases including coronary artery disease, cerebrovascular disease and peripheral artery disease.
- Hypertensive, as defined as SBP superior or equal to 140 mmHg or DBP superior or equal to 90 mmHg.
- Obese participants, defined as BMI superior or equal to 30.
- Diabetes mellitus and metabolic syndrome.
- Acute inflammation, terminal renal failure or malignancies.
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 |
|---|---|---|
| Wild Blueberry PowderFreeze-dried whole fruit blueberry drink. | Dietary supplement | Wild Blueberry powder |
| PlaceboFreeze-dried placebo powder | Dietary supplement | Placebo |
Primary outcome
Cognitive function
Time frame: Change from baseline cognitive function at 2 hours post-consumption
Cognitive testing involves the participant conducting tasks administered on a tablet-style laptop. The participants will be conducting these tasks whilst cerebral blood flow measurements are taking place. The cognitive testing battery will consist of 4 tasks including a mood assessment (PANAS).
Endothelial Function
Time frame: Change from baseline endothelial function at 2 hours post-consumption
Flow mediated dilation (FMD)
2 secondary outcomes
Cerebral blood flow (CBF)
Time frame: Change of baseline cerebral blood flow at 2 hours post consumption
Blood pressure
Time frame: Change from baseline systolic blood pressure at 2 hours post consumption
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 19 May 2021.
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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 Wild Blueberry Powder in people with Healthy, run by King's College London 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 4 inclusion and 16 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 19 May 2021. 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: Change from baseline cognitive function at 2 hours post-consumption). 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?
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 19 May 2021.