Healthy AgingBluFlowNCT04084457
Investigating the Effects of Daily Consumption of Blueberry (Poly)Phenols on Vascular Function and Cognitive Performance
A study testing Wild Blueberry powder in people with Healthy Aging and Healthy, run by King's College London at 1 site in United Kingdom.
Trial summary
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Aging, Healthy
- What is being tested?
- Wild Blueberry powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 53 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 4 Sep 2019to 17 Apr 2020
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Participants will include 60 healthy male and female volunteers, aged 65-80.
- Volunteers will be able to understand the nature of the study and able to give signed written informed consent.
- Subjects 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.
- Allergies to berries or another significant food allergy.
Show all 15Show fewer
- 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 irregularly.
- 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.
United Kingdom1 site
Franklin-Wilkins Building, King's College London
London, SE1 9NH
About this study
Official title: Randomised, Double-blind, Placebo Controlled, Parallel Trial Investigating the Daily Effects of Blueberry (Poly)Phenol Consumption on Vascular Function and Cognitive Performance in Healthy Elderly Individuals
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial investigating the effects of daily blueberry (poly)phenol consumption on vascular function and cognitive performance in healthy elderly individuals. The study will be conducted at King's College London, Franklin-Wilkins Building.
Eligible subjects will be healthy males and females aged 65-80.
Read the detailed description
To date no study has investigated whether daily blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, the investigators aim to directly link daily blueberry consumption with improved vascular function, increased cerebral blood flow and positive cognitive outcomes in healthy elderly individuals. The investigators will use a large group of elderly individuals' representative of a healthy population, both males and females, aged 65-80 years to evaluate the health effects of daily blueberry consumption.
The main aim is to investigate whether improvements in vascular and cognitive function previously seen after blueberry consumption can be seen following 3-months daily consumption in elderly individuals, and whether enhanced cognitive performance is correlated with increased cerebral blood flow. The investigators hypothesise that daily consumption of an anthocyanin rich blueberry drink will improve cognitive performance and vascular function, increasing cerebral blood flow, in healthy older individuals.
- Conditions
- Healthy Aging, Healthy
- Being tested
- Wild Blueberry powder, Placebo
- Keywords
- polyphenols, Blueberries, cognition, vascular function, vascular health, cognitive function, anthocyanins, flavonoids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wild Blueberry powderDietary supplement
Powdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered.
PlaceboDietary supplement
Identical formulation as the treatment matched for fibre and vitamin C
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Matched for macronutrients, micronutrients and fibre Receives: Dietary Supplement: Placebo |
| Wild Blueberry Powder | Active comparator | Formulation of a 100% blueberry (freeze-dried whole fruit) drink Receives: Dietary Supplement: Wild Blueberry powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Function
Changes in flow-mediated dilation of the brachial artery (FMD) from baseline after 12-week consumption of blueberry vs control
Measured: Baseline and 12 weeks post-intervention
Cognitive function
Changes in cognitive function from baseline after 12-week consumption of blueberry vs control. 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 which are Auditory Verbal learning task, Corsi Blocks, Switching task and Serials 3's and 7's, including a mood assessment (PANAS).
Measured: Baseline and 12 weeks post-intervention
Secondary outcomes (14)
Cerebral blood flow velocity (CBFv)
Changes in cerebral blood flow velocity (CBFv) from baseline after 12-week consumption of blueberry vs control. Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD). Variables measured include resting and active mean blood flow velocity (cm/s).
Measured: Baseline and 12 weeks post-intervention
Office systolic blood pressure
Changes from baseline office systolic blood pressure (mmHg) after 12-week consumption of blueberry vs control.
Measured: Baseline and 12 weeks post-intervention
Pulse wave velocity (PWV)
Determine the changes in Pulse wave velocity (PWV) from baseline after 12-week consumption of blueberry vs control.
Measured: Baseline and 12 weeks post-intervention
Augmentation Index (AIx)
Changes in augmentation Index (AIx) using a Sphygmocor device post consumption of a placebo or blueberry treatment
Measured: Baseline and 12 weeks post-intervention
24-hour ambulatory systolic blood pressure
Determine the effect of the blueberry extract vs Placebo on 24-hour systolic blood pressure using a monitor, at 12 weeks post consumption. Variables include mean asleep, awake and total 24 h systolic blood pressure
Measured: Baseline and 12 weeks post-intervention
Mood
Assessment using a self-reported questionnaire using the Positive and Negative Affect Schedule (PANAS).PANAS (The Positive and Negative Affect Schedule) to measure mood, where the participants will need to answer 20 questions using a 5-point likert scale that ranges from (1) not at all to (5) extremely. Dependent variables are composite positive affect and negative affect scores obtained by summing responses to positive or negative PANAS items, respectively.
Measured: Baseline and 12 weeks post-intervention
Change in Blood lipids concentration (Total, HDL and LDL cholesterol, triglycerides)
Determine the effect of the blueberry extract vs Placebo on blood lipids (Total, HDL and LDL cholesterol, triglycerides), at 12 weeks post consumption.
Measured: Baseline and 12 weeks post-intervention
Plasma blueberry (poly)phenol metabolites
Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours post consumption
Measured: Baseline and 12 weeks post-intervention
Microbiome analysis
Stool sample collection involving an all-in-one kit for self-collection and stabilization of microbial DNA from faeces for gut microbiome profiling.
Measured: Baseline and 12 weeks post-intervention
Urine blueberry polyphenol metabolites
Collected over a 24 hour period. Measured by liquid chromotography- mass spectrometry (LC/MS) 0 and 2 hours post consumption
Measured: Baseline and 12 weeks post-intervention
Number of volunteers with treatment-related adverse events
The number of volunteers with treatment-related adverse events will be assessed by questionnaires and interviews.
Measured: Baseline and 12 weeks post-intervention
Pulsatility index (PI)
Changes in pulsatility index (PI) from baseline after 12-week consumption of blueberry vs control. Trans-cranial blood flow will be assessed by Non-imaging transcranial Doppler sonography (TCD). Variables measured include resting and active PI (cm/s.
Measured: Baseline and 12 weeks post-intervention
Office diastolic blood pressure
Changes from baseline office diastolic blood pressure (mmHg) after 12-week consumption of blueberry vs control.
Measured: Baseline and 12 weeks post-intervention
24-hour ambulatory diastolic blood pressure
Determine the effect of the blueberry extract vs Placebo on 24-hour diastolic blood pressure using a monitor, at 12 weeks post consumption. Variables include mean asleep, awake and total 24 h diastolic blood pressure
Measured: Baseline and 12 weeks post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2019
- Study start4 Sep 2019
- Primary completion17 Apr 2020
- Study completion17 Apr 2020
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 Healthy AgingStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 53 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
- Investigators
- Ana Rodriguez-Mateos, PhD, Principal investigator, Principal Investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04084457
- Sponsor's protocol ID
- BluFlow
- Acronym
- BluFlow
- Status last verified
- Jul 2021
- First submitted
- 2 Sep 2019
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Wood E, Hein S, Mesnage R, Fernandes F, Abhayaratne N, Xu Y, Zhang Z, Bell L, Williams C, Rodriguez-Mateos A. Wild blueberry (poly)phenols can improve vascular function and cognitive performance in healthy older individuals: a double-blind randomized controlled trial. Am J Clin Nutr. 2023 Jun;117(6):1306-1319. doi: 10.1016/j.ajcnut.2023.03.017. Epub 2023 Mar 25.
PubMed 36972800
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised, Double-blind, Placebo Controlled, Parallel Trial Investigating the Daily Effects of Blueberry (Poly)Phenol Consumption on Vascular Function and Cognitive Performance in Healthy Elderly Individuals
- ClinicalTrials.gov ID
- NCT04084457
- Acronym / sponsor ID
- BluFlow / BluFlow
- Conditions
- Healthy Aging, Healthy
- Keywords
- polyphenols, Blueberries, cognition, vascular function, vascular health, cognitive function, anthocyanins, flavonoids
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Reading
- Study start
- 4 Sep 2019 (actual)
- Primary completion
- 17 Apr 2020 (actual)
- Study completion
- 17 Apr 2020 (actual)
- First posted
- 10 Sep 2019 (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.
Foods rich in certain (poly)phenols, particularly flavonoids, such as berries and cocoa, have been shown to improve measures of vascular function as well as cognitive performance in human intervention studies. This is a randomized, double-blind, placebo controlled, parallel trial investigating the effects of daily blueberry (poly)phenol consumption on vascular function and cognitive performance in healthy elderly individuals. The study will be conducted at King's College London, Franklin-Wilkins Building.
Eligible subjects will be healthy males and females aged 65-80.
Detailed description
To date no study has investigated whether daily blueberry consumption can induce an increase in cerebral blood flow, with subsequent improvements in vascular and cognitive function. In this study, the investigators aim to directly link daily blueberry consumption with improved vascular function, increased cerebral blood flow and positive cognitive outcomes in healthy elderly individuals. The investigators will use a large group of elderly individuals' representative of a healthy population, both males and females, aged 65-80 years to evaluate the health effects of daily blueberry consumption.
The main aim is to investigate whether improvements in vascular and cognitive function previously seen after blueberry consumption can be seen following 3-months daily consumption in elderly individuals, and whether enhanced cognitive performance is correlated with increased cerebral blood flow. The investigators hypothesise that daily consumption of an anthocyanin rich blueberry drink will improve cognitive performance and vascular function, increasing cerebral blood flow, in healthy older individuals.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Dietary Supplement: PlaceboMatched for macronutrients, micronutrients and fibre |
| Wild Blueberry Powder | Active comparator | Dietary Supplement: Wild Blueberry powderFormulation of a 100% blueberry (freeze-dried whole fruit) drink |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Participants will include 60 healthy male and female volunteers, aged 65-80.
- Volunteers will be able to understand the nature of the study and able to give signed written informed consent.
- Subjects 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 (15 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 powderPowdered extract obtained from wild blueberries. A daily administration of 27g wild blueberry powder will be administered. | Dietary supplement | Wild Blueberry Powder |
| PlaceboIdentical formulation as the treatment matched for fibre and vitamin C | Dietary supplement | Placebo |
Primary outcome
Endothelial Function
Time frame: Baseline and 12 weeks post-intervention
Changes in flow-mediated dilation of the brachial artery (FMD) from baseline after 12-week consumption of blueberry vs control
Cognitive function
Time frame: Baseline and 12 weeks post-intervention
Changes in cognitive function from baseline after 12-week consumption of blueberry vs control. 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 which are Auditory Verbal learning task, Corsi Blocks, Switching task and Serials 3's and 7's, including a mood assessment (PANAS).
14 secondary outcomes
Cerebral blood flow velocity (CBFv)
Time frame: Baseline and 12 weeks post-intervention
Office systolic blood pressure
Time frame: Baseline and 12 weeks post-intervention
Pulse wave velocity (PWV)
Time frame: Baseline and 12 weeks post-intervention
Augmentation Index (AIx)
Time frame: Baseline and 12 weeks post-intervention
24-hour ambulatory systolic blood pressure
Time frame: Baseline and 12 weeks post-intervention
Mood
Time frame: Baseline and 12 weeks post-intervention
Change in Blood lipids concentration (Total, HDL and LDL cholesterol, triglycerides)
Time frame: Baseline and 12 weeks post-intervention
Plasma blueberry (poly)phenol metabolites
Time frame: Baseline and 12 weeks post-intervention
Microbiome analysis
Time frame: Baseline and 12 weeks post-intervention
Urine blueberry polyphenol metabolites
Time frame: Baseline and 12 weeks post-intervention
Number of volunteers with treatment-related adverse events
Time frame: Baseline and 12 weeks post-intervention
Pulsatility index (PI)
Time frame: Baseline and 12 weeks post-intervention
Office diastolic blood pressure
Time frame: Baseline and 12 weeks post-intervention
24-hour ambulatory diastolic blood pressure
Time frame: Baseline and 12 weeks post-intervention
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 12 Jul 2021.
- Derived from this study: PubMed 36972800Wood E, Hein S, Mesnage R, Fernandes F, Abhayaratne N, Xu Y, Zhang Z, Bell L, Williams C, Rodriguez-Mateos A. Wild blueberry (poly)phenols can improve vascular function and cognitive performance in healthy older individuals: a double-blind randomized controlled trial. Am J Clin Nutr. 2023 Jun;117(6):1306-1319. doi: 10.1016/j.ajcnut.2023.03.017. Epub 2023 Mar 25.
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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.
Ana Rodriguez-Mateos, PhD principal investigator
Principal Investigator
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 Aging and 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 3 inclusion and 15 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 12 Jul 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?
Endothelial Function (time frame: Baseline and 12 weeks 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 NCT04084457, 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 12 Jul 2021.