Endothelial FunctionBB2NCT01829542
Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals
A study testing Freeze-dried blueberry powder dissolved in water in people with Endothelial Function, run by University of Reading at 1 site in United Kingdom.
Trial summary
The purpose of this study is to assess the impact of acute blueberry polyphenol intake on endothelial function of healthy volunteers. Specifically, the investigators plan to perform a randomised, double blind, cross-over human intervention trial using a blueberry drink to investigate the dose-dependent effects of… Read more about this study
- Who is it for?
- Ages 18 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Function
- What is being tested?
- Freeze-dried blueberry powder dissolved in water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- May 2012to Oct 2012
- 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 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male
- 18-40 years
- Healthy
- signed consent form
Who cannot join
- Blood pressure > 140/90 mmHg
- Had suffered a myocardial infarction or stroke
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
- Allergies or intolerances to any foods
Show all 16Show fewer
- Smoker
- Heavy drinker (>21 units per week)
- On any lipid-modifying medication
- On any blood pressure lowering medication
- On any medication affecting blood clotting
- Taking high dose fish oil supplements (greater then 1 g EPA and DHA per day) or high doses of antioxidant vitamins (greater then 800 μg vitamin A, 60 mg vitamin C, 10 mg vitamin E or 400 μg beta carotene)
- Taking probiotics, prebiotics, synbiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study
- Planning on altering consumption of vitamin supplements/fish oil capsules during the course of the study
- Undertakes strenuous exercise > 4 times per week for > 1 hour per session
- Haemoglobin levels below reference range provided by the Royal Berkshire Hospital
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Hugh Sinclair Unit of Human Nutrition
Reading, Berkshire, RG6 6AP
About this study
The purpose of this study is to assess the impact of acute blueberry polyphenol intake on endothelial function of healthy volunteers. Specifically, the investigators plan to perform a randomised, double blind, cross-over human intervention trial using a blueberry drink to investigate the dose-dependent effects of blueberry polyphenols on blood vessel function using Flow mediated dilation (FMD) to measure endothelial function. The study will not only measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess plasma polyphenol metabolite levels.
- Conditions
- Endothelial Function
- Being tested
- Freeze-dried blueberry powder dissolved in water, Control
- Keywords
- flow-mediated dilation, blueberry polyphenols, dose-dependency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freeze-dried blueberry powder dissolved in waterDietary supplement
Wild blueberry freeze-dried powder dissolved in water
ControlDietary supplement
Macro- and micro-nutrient matched control in water
| Study group | Role | What they receive |
|---|---|---|
| 319 mg blueberry polyphenols | Active comparator | Freeze-dried blueberry powder dissolved in water Receives: Dietary Supplement: Freeze-dried blueberry powder dissolved in water |
| 639 mg blueberry polyphenols | Active comparator | Freeze-dried blueberry powder dissolved in water Receives: Dietary Supplement: Freeze-dried blueberry powder dissolved in water |
| 766 mg blueberry polyphenols | Active comparator | Freeze-dried blueberry powder dissolved in water Receives: Dietary Supplement: Freeze-dried blueberry powder dissolved in water |
| 1466 mg blueberry polyphenols | Active comparator | Freeze-dried blueberry powder dissolved in water Receives: Dietary Supplement: Freeze-dried blueberry powder dissolved in water |
| 1791 mg total blueberry polyphenols | Active comparator | Freeze-dried blueberry powder dissolved in water Receives: Dietary Supplement: Freeze-dried blueberry powder dissolved in water |
| O mg blueberry polyphenols | Placebo comparator | Macro- and micronutrient matched control drink Receives: Dietary Supplement: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow-mediated dilation
Measured: 0-1 hour after consumption
Secondary outcomes (1)
plasma blueberry polyphenol metabolites
Measured: 0-1 h after consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2013 (estimated)
- Study startMay 2012
- Primary completionAug 2012
- Study completionOct 2012
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 Endothelial FunctionStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Collaborators
- Alpro Foundation
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01829542
- Sponsor's protocol ID
- BB2UReading
- Acronym
- BB2
- Status last verified
- Apr 2013
- First submitted
- 8 Apr 2013
- Last updated
- 11 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Mateos A, Rendeiro C, Bergillos-Meca T, Tabatabaee S, George TW, Heiss C, Spencer JP. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity. Am J Clin Nutr. 2013 Nov;98(5):1179-91. doi: 10.3945/ajcn.113.066639. Epub 2013 Sep 4.
PubMed 24004888
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dose-dependent Effects of Blueberry Polyphenols on Endothelial Function in Healthy Individuals
- ClinicalTrials.gov ID
- NCT01829542
- Acronym / sponsor ID
- BB2 / BB2UReading
- Conditions
- Endothelial Function
- Keywords
- flow-mediated dilation, blueberry polyphenols, dose-dependency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Collaborators
- Alpro Foundation
- Study start
- May 2012
- Primary completion
- Aug 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 11 Apr 2013 (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.
The purpose of this study is to assess the impact of acute blueberry polyphenol intake on endothelial function of healthy volunteers. Specifically, the investigators plan to perform a randomised, double blind, cross-over human intervention trial using a blueberry drink to investigate the dose-dependent effects of blueberry polyphenols on blood vessel function using Flow mediated dilation (FMD) to measure endothelial function. The study will not only measure the acute effects of flavonoid ingestion on vascular reactivity but will also assess plasma polyphenol metabolite levels.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 319 mg blueberry polyphenols | Active comparator | Dietary Supplement: Freeze-dried blueberry powder dissolved in waterFreeze-dried blueberry powder dissolved in water |
| 639 mg blueberry polyphenols | Active comparator | Dietary Supplement: Freeze-dried blueberry powder dissolved in waterFreeze-dried blueberry powder dissolved in water |
| 766 mg blueberry polyphenols | Active comparator | Dietary Supplement: Freeze-dried blueberry powder dissolved in waterFreeze-dried blueberry powder dissolved in water |
| 1466 mg blueberry polyphenols | Active comparator | Dietary Supplement: Freeze-dried blueberry powder dissolved in waterFreeze-dried blueberry powder dissolved in water |
| 1791 mg total blueberry polyphenols | Active comparator | Dietary Supplement: Freeze-dried blueberry powder dissolved in waterFreeze-dried blueberry powder dissolved in water |
| O mg blueberry polyphenols | Placebo comparator | Dietary Supplement: ControlMacro- and micronutrient matched control drink |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male
- 18-40 years
- Healthy
- signed consent form
Key exclusion criteria (16 listed)
- Blood pressure > 140/90 mmHg
- Had suffered a myocardial infarction or stroke
- Suffers from any blood-clotting disorder
- Suffers from any metabolic disorders (e.g. diabetes or any other endocrine or liver diseases)
- Any dietary restrictions or on a weight reducing diet
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 |
|---|---|---|
| Freeze-dried blueberry powder dissolved in waterWild blueberry freeze-dried powder dissolved in water | Dietary supplement | 1466 mg blueberry polyphenols, 1791 mg total blueberry polyphenols, 319 mg blueberry polyphenols, 639 mg blueberry polyphenols, 766 mg blueberry polyphenols |
| ControlMacro- and micro-nutrient matched control in water | Dietary supplement | O mg blueberry polyphenols |
Primary outcome
Flow-mediated dilation
Time frame: 0-1 hour after consumption
1 secondary outcome
plasma blueberry polyphenol metabolites
Time frame: 0-1 h after 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 11 Apr 2013.
- Derived from this study: PubMed 24004888Rodriguez-Mateos A, Rendeiro C, Bergillos-Meca T, Tabatabaee S, George TW, Heiss C, Spencer JP. Intake and time dependence of blueberry flavonoid-induced improvements in vascular function: a randomized, controlled, double-blind, crossover intervention study with mechanistic insights into biological activity. Am J Clin Nutr. 2013 Nov;98(5):1179-91. doi: 10.3945/ajcn.113.066639. Epub 2013 Sep 4.
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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 Freeze-dried blueberry powder dissolved in water in people with Endothelial Function, 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 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 11 Apr 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?
Flow-mediated dilation (time frame: 0-1 hour after consumption). 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 NCT01829542, 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 11 Apr 2013.