Vascular StiffnessNCT04015258
Blueberry Study Aimed at Improving Cognition and Peripheral Blood Flow
A study testing Blueberries, Blueberry powder and Blueberry components capsules in people with Vascular Stiffness and Cognitive Change, run by Northumbria University at 1 site in United Kingdom.
Trial summary
Blueberries are rich in the content of a variety of biologically active chemicals that contribute to their health properties. The consumption of blueberries has beneficial effects on vascular function and brain health and function. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Vascular Stiffness, Cognitive Change, Blood Pressure
- What is being tested?
- Blueberries, Blueberry powder and Blueberry components capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 36 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2019to 1 Jan 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Interested in taking part in the study
- Healthy
- Aged 18-60 years (inclusive)
Who cannot join
- Smoking
- Aged under 18 or over 60
- Blood Pressure ≥ 145/100 mmHg and are taking medication
- Have vascular disease, or other cardiac abnormalities
- Have previously suffered any head injuries, history of seizures or other neurological disorders
- Have any metabolic disorders, malabsorption syndromes or gastrointestinal complications
Show all 19Show fewer
- Current use of above disease relevant prescription medications (excluding contraception)
- Irregular bowel function (less than 1 bowel movement per day)
- Regularly consume blueberries/blueberry-contained products more than twice per week
- Have regularly used nutritional supplements or medications within the previous 3 months (defined as more than 3 consecutive days or 4 days in total)
- Learning difficulties and dyslexia
- Visual impairment that cannot be corrected with glasses or contact lenses including colour blindness
- Currently suffer from migraines (> 1 per month)
- Body mass index (BMI) under 18.5 or over 30
- Pregnancy, seeking to become pregnant, or current lactation
- Inability to complete all of the study assessments
- Current participation in other clinical or nutrition intervention studies
- Not proficient in English equivalent to IELTS band 6 or above
- Have any known active infections
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne and Wear, NE1 8ST
About this study
Official title: Metabolic Mechanisms Underlying the Responsiveness to Blueberry Interventions Aimed at Improving Cognition and Peripheral Blood Flow
Blueberries are rich in the content of a variety of biologically active chemicals that contribute to their health properties. The consumption of blueberries has beneficial effects on vascular function and brain health and function. Blueberries are present in human diet in a number of forms, but the investigator do not know which form is best for health and why people respond differently to eating blueberries.
The aim of the present study is to assess the effects of 1 week's supplementation of whole blueberries or freeze-dried blueberry powder or encapsulated blueberry components on vascular function and brain health and function. Investigators will then categorise participants as those who have large effects of the intervention (responders) and those that don't show much effect at all (non-responders). Then the investigators will look into the role that genes play in this response and determine if metabolism is similar in these groups of participants. Any changes in participants' brain health and vascular function will be linked to these metabolic and genomic pathways, and this will help the investigators to further understand how blueberry consumption can benefit human health.
Read the detailed description
Study design: The present study will supply either 160 g of fresh whole blueberry (4 handful portion) or 20 g of freeze-dried blueberry powder (measured with tablespoon provided; equivalent to 160 g of whole fresh blueberry), or placebo capsule with only microcrystalline cellulose (approx. 10 g, they will be blinded that this is encapsulated blueberry extract components) to 80 subjects on separate occasions with age range of 18-60 years old for 1 week with 1 week of washout period. Fresh blueberries will be purchased from local supermarkets; freeze-dried blueberry powder will be purchased from Lio-Licious freeze-dried fruits range; the microcrystalline cellulose will be purchased from Blackburn Distributions. There is no outside interest that could constitute commercial conflict of interest.
Methodology and sampling strategy: a randomised crossover design will be implemented. The study is a quantitative experiment and participants will be recruited through opportunity sampling.
Data collection: On each visit, cognition data will be obtained from computerised testing system COMPASS. Blood pressure will be obtained using fully automatic oscillometric device. On visits 2-7, PWV value is obtained by SphygmoCor; untargeted metabolomics and genomic data will be obtained from blood and urine sample collection.
For data analysis: The identification of responders to the treatments will be done by the calculation of response level first: response level = (change from baseline score/baseline score) x 100%. The calculated percentage will be used to characterise subjects from lowest response to highest response level. The association among -omics biomarkers and cognitive tests/endothelial parameters, lipid status under each treatment will be analysed using linear regression models after adjusting for confounding factors like age. Pathway analysis will be used to identify metabolic pathways that characterise responders and non-responders. Pathways will be identified using discriminatory metabolites from metabolomics and SNP analysis.
- Conditions
- Vascular Stiffness, Cognitive Change, Blood Pressure
- Being tested
- Blueberries, Blueberry powder, Blueberry components capsules
- Keywords
- blueberry, intervention, endothelial function, cognition, metabolomics, genomics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BlueberriesDietary supplement
fresh spanish blueberries
Blueberry powderDietary supplement
freeze-dried blueberry powder
Blueberry components capsulesDietary supplement
encapsulated blueberry components (microcrystalline cellulose powder in actual)
| Study group | Role | What they receive |
|---|---|---|
| Blueberries | Experimental | Fresh blueberries purchased from local supermarket will be distributed to each participant for 1 week's consumption, 160 grams per day Receives: Dietary Supplement: Blueberries |
| Blueberry powder | Experimental | Freeze-dried blueberry powder will be distributed to each participant for 1 week's consumption, 20 grams per day, equivalent to 160 grams of fresh blueberries Receives: Dietary Supplement: Blueberry powder |
| Blueberry components capsules | Placebo comparator | Encapsulated microcrystalline cellulose powder will be blinded as blueberry components capsules to be distributed to each participant for 1 week's consumption Receives: Dietary Supplement: Blueberry components capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Accuracy of participant recalling word list Immediately
will be assessed via COMPASS (Computerised Mental Performance Assessment System) tasks by participants recalling word list immediately after displays; the result will be presented as accuracy (%) and as an assessment of short-term memory
Measured: 1 minute
Correct responses of participants counting down from certain number by subtracting 3
will be assessed via COMPASS tasks by participants counting down from certain number by threes. The result will be presented as correct responses and as an assessment of executive function
Measured: 5 minutes
Correct responses of participants counting down from certain number by subtracting 7
will be assessed via COMPASS tasks by participants counting down from certain number by sevens, the result will be presented as correct responses and as an assessment of executive function
Measured: 5 minutes
Reaction time of participants' vigilance during rapid visual tracking and accurate selection of target digit stimuli
will be assessed via COMPASS tasks by measuring participants' vigilance during rapid visual tracking and accurate selection of target stimuli, presented by reaction time in millisecond (ms), as an assessment of attention and psychomotor speed
Measured: 5 minutes
Accuracy of participant recalling word list 30 minutes after displays
will be assessed via COMPASS tasks by participants recalling word list after 30 minutes, the result will be presented as accuracy (%) and as an assessment of memory
Measured: 5 minutes
Brachial-radial distance
brachial-radial distance in meters (m), will be measured by tape
Measured: 1 minute
Pulse wave time
time of the pulse wave moves down from brachial to radial artery in seconds (s), will be measured by Sphygmocor (ScanMed medical)
Measured: 10 minutes
Pulse wave velocity (PWV)
will be measured by Sphygmocor (ScanMed medical), by outcome 7 pulse wave time (s) dividing outcome 6 brachial-radial distance (m), PWV will be presented in the units of m/s, as an assessment of endothelial function
Measured: 10 minutes
Blood Pressure
will be assessed by BP monitor and reported in the units of mm Hg
Measured: 10 minutes
Secondary outcomes (5)
Inter-cellular Adhesion Molecules (ICAMs) and Vascular Cell Adhesion Molecules (VCAMs)
Endothelial dysfunction's biomarkers (ICAMs and VCAMs) assessed by ELISA Kits and reported in the units of U/mL
Measured: 1 day
C-reactive Protein (CRP)
Endothelial dysfunction's biomarkers (CRP) assessed by ELISA Kits in the units of mg/L
Measured: 1 day
Plasma Lipid Status
Total and High-density lipoprotein (HDL-), Low-density lipoprotein (LDL-) cholesterol and triglycerides assessed by outsourcing to the local hospital, the results will be reported in the units of mmol/L
Measured: 1 day
Untargeted Plasma and Urine Metabolites
liquid-chromatography mass spectrometry-based techniques (LCMS) will be applied to identify untargeted metabolites in the plasma and urine samples
Measured: 1 day
Single Nucleotide Polymorphisms (SNPs)
SNP arrays will be applied for genotyping participants' DNA collected from the buffy coat of the blood sample, following the removal of plasma
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2019
- Study start1 Jan 2019
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yueyue Wang, Principal investigator, Miss
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04015258
- Sponsor's protocol ID
- Research Ethics 10113
- Status last verified
- Jul 2019
- First submitted
- 4 Mar 2019
- Last updated
- 4 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Mechanisms Underlying the Responsiveness to Blueberry Interventions Aimed at Improving Cognition and Peripheral Blood Flow
- ClinicalTrials.gov ID
- NCT04015258
- Acronym / sponsor ID
- Research Ethics 10113
- Conditions
- Vascular Stiffness, Cognitive Change, Blood Pressure
- Keywords
- blueberry, intervention, endothelial function, cognition, metabolomics, genomics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 10 Jul 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.
Blueberries are rich in the content of a variety of biologically active chemicals that contribute to their health properties. The consumption of blueberries has beneficial effects on vascular function and brain health and function. Blueberries are present in human diet in a number of forms, but the investigator do not know which form is best for health and why people respond differently to eating blueberries.
The aim of the present study is to assess the effects of 1 week's supplementation of whole blueberries or freeze-dried blueberry powder or encapsulated blueberry components on vascular function and brain health and function. Investigators will then categorise participants as those who have large effects of the intervention (responders) and those that don't show much effect at all (non-responders). Then the investigators will look into the role that genes play in this response and determine if metabolism is similar in these groups of participants. Any changes in participants' brain health and vascular function will be linked to these metabolic and genomic pathways, and this will help the investigators to further understand how blueberry consumption can benefit human health.
Detailed description
Study design: The present study will supply either 160 g of fresh whole blueberry (4 handful portion) or 20 g of freeze-dried blueberry powder (measured with tablespoon provided; equivalent to 160 g of whole fresh blueberry), or placebo capsule with only microcrystalline cellulose (approx. 10 g, they will be blinded that this is encapsulated blueberry extract components) to 80 subjects on separate occasions with age range of 18-60 years old for 1 week with 1 week of washout period. Fresh blueberries will be purchased from local supermarkets; freeze-dried blueberry powder will be purchased from Lio-Licious freeze-dried fruits range; the microcrystalline cellulose will be purchased from Blackburn Distributions. There is no outside interest that could constitute commercial conflict of interest.
Methodology and sampling strategy: a randomised crossover design will be implemented. The study is a quantitative experiment and participants will be recruited through opportunity sampling.
Data collection: On each visit, cognition data will be obtained from computerised testing system COMPASS. Blood pressure will be obtained using fully automatic oscillometric device. On visits 2-7, PWV value is obtained by SphygmoCor; untargeted metabolomics and genomic data will be obtained from blood and urine sample collection.
For data analysis: The identification of responders to the treatments will be done by the calculation of response level first: response level = (change from baseline score/baseline score) x 100%. The calculated percentage will be used to characterise subjects from lowest response to highest response level. The association among -omics biomarkers and cognitive tests/endothelial parameters, lipid status under each treatment will be analysed using linear regression models after adjusting for confounding factors like age. Pathway analysis will be used to identify metabolic pathways that characterise responders and non-responders. Pathways will be identified using discriminatory metabolites from metabolomics and SNP analysis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Blueberries | Experimental | Dietary Supplement: BlueberriesFresh blueberries purchased from local supermarket will be distributed to each participant for 1 week's consumption, 160 grams per day |
| Blueberry powder | Experimental | Dietary Supplement: Blueberry powderFreeze-dried blueberry powder will be distributed to each participant for 1 week's consumption, 20 grams per day, equivalent to 160 grams of fresh blueberries |
| Blueberry components capsules | Placebo comparator | Dietary Supplement: Blueberry components capsulesEncapsulated microcrystalline cellulose powder will be blinded as blueberry components capsules to be distributed to each participant for 1 week's consumption |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Interested in taking part in the study
- Healthy
- Aged 18-60 years (inclusive)
Key exclusion criteria (19 listed)
- Smoking
- Aged under 18 or over 60
- Blood Pressure ≥ 145/100 mmHg and are taking medication
- Have vascular disease, or other cardiac abnormalities
- Have previously suffered any head injuries, history of seizures or other neurological disorders
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 |
|---|---|---|
| Blueberriesfresh spanish blueberries | Dietary supplement | Blueberries |
| Blueberry powderfreeze-dried blueberry powder | Dietary supplement | Blueberry powder |
| Blueberry components capsulesencapsulated blueberry components (microcrystalline cellulose powder in actual) | Dietary supplement | Blueberry components capsules |
Primary outcome
Accuracy of participant recalling word list Immediately
Time frame: 1 minute
will be assessed via COMPASS (Computerised Mental Performance Assessment System) tasks by participants recalling word list immediately after displays; the result will be presented as accuracy (%) and as an assessment of short-term memory
Correct responses of participants counting down from certain number by subtracting 3
Time frame: 5 minutes
will be assessed via COMPASS tasks by participants counting down from certain number by threes. The result will be presented as correct responses and as an assessment of executive function
Correct responses of participants counting down from certain number by subtracting 7
Time frame: 5 minutes
will be assessed via COMPASS tasks by participants counting down from certain number by sevens, the result will be presented as correct responses and as an assessment of executive function
Reaction time of participants' vigilance during rapid visual tracking and accurate selection of target digit stimuli
Time frame: 5 minutes
will be assessed via COMPASS tasks by measuring participants' vigilance during rapid visual tracking and accurate selection of target stimuli, presented by reaction time in millisecond (ms), as an assessment of attention and psychomotor speed
Accuracy of participant recalling word list 30 minutes after displays
Time frame: 5 minutes
will be assessed via COMPASS tasks by participants recalling word list after 30 minutes, the result will be presented as accuracy (%) and as an assessment of memory
Brachial-radial distance
Time frame: 1 minute
brachial-radial distance in meters (m), will be measured by tape
Pulse wave time
Time frame: 10 minutes
time of the pulse wave moves down from brachial to radial artery in seconds (s), will be measured by Sphygmocor (ScanMed medical)
Pulse wave velocity (PWV)
Time frame: 10 minutes
will be measured by Sphygmocor (ScanMed medical), by outcome 7 pulse wave time (s) dividing outcome 6 brachial-radial distance (m), PWV will be presented in the units of m/s, as an assessment of endothelial function
Blood Pressure
Time frame: 10 minutes
will be assessed by BP monitor and reported in the units of mm Hg
5 secondary outcomes
Inter-cellular Adhesion Molecules (ICAMs) and Vascular Cell Adhesion Molecules (VCAMs)
Time frame: 1 day
C-reactive Protein (CRP)
Time frame: 1 day
Plasma Lipid Status
Time frame: 1 day
Untargeted Plasma and Urine Metabolites
Time frame: 1 day
Single Nucleotide Polymorphisms (SNPs)
Time frame: 7 days
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 4 Mar 2020.
- Individual participant dataSharing planned: No
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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.
Yueyue Wang principal investigator
Miss
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blueberries, Blueberry powder and Blueberry components capsules in people with Vascular Stiffness and Cognitive Change, 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 19 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 4 Mar 2020. 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?
Accuracy of participant recalling word list Immediately (time frame: 1 minute). The study lists 9 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 4 Mar 2020.