Vascular FunctionTNCT02273323
Flow Mediated Dilation in Response to Black Tea
A study testing Tea in people with Vascular Function, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Vascular Function
- What is being tested?
- Tea
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Oct 2014to Oct 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and post menopausal (> 1 year) females, not on hormone replacement therapy
- Aged >18 and < 65 years
- Body mass index (BMI) of >=18.0 and =<35.0 kg/m2
- Hypertension as previously diagnosed by primary care or hospital physician.
- If untreated, office BP between 140/90 mmHg and 160/100 mmHg on screening
- If treated, a controlled blood pressure (<160/100) on stable medication for at least 4 weeks
Who cannot join
- Tea drinkers: having typically consumed > 1 cup of black tea per week.
- Current smoker or has stopped smoking less than 6 months before start of study
- Self reported alcohol intake of >21 units/week
- Established cardiovascular disease other than hypertension
- Clinically significant arrhythmia
- Diabetes mellitus
Show all 10Show fewer
- Chronic Kidney Disease > stage 2
- 10-year cardiovascular risk equivalent to 20% or greater using the QRisk2 calculator
- Abnormality of laboratory blood tests considered clinically significant
- Any other significant intercurrent condition/disease
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Dept Clinical Pharmacology/CRF, St Thomas Hospital
London, SE1 7EH
About this study
Official title: Flow Mediated Dilation in Response to Consumption of Black Tea Versus Artificial Tea, in Non-tea Drinking Hypertensive Subjects.
Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.
Read the detailed description
Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.
- Conditions
- Vascular Function
- Being tested
- Tea, Placebo
- Keywords
- Flow mediated dilation, tea, blood pressure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TeaOther
Single dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar.
PlaceboOther
Placebo: tea flavour, colouring and sugar
| Study group | Role | What they receive |
|---|---|---|
| Tea | Experimental | Black tea Receives: Other: Tea |
| Placebo | Placebo comparator | Placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation
Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software:
- 1 minute baseline scan to measure the baseline diameter of artery
- 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter
Measured: Before and 2 hours after test product intake
Secondary outcomes (5)
Endothelium-independent Vasodilation
Endothelium-independent dilation after glyceryl trinitrate defined as maximal percent increase in diameter
Measured: 2.5 hours after test product intake
Systolic Blood Pressure Supine
Systolic blood pressure measured while lying down
Measured: Before and 110 minutes after test product intake
Diastolic Blood Pressure Supine
Diastolic blood pressure measured while lying down
Measured: Before and 110 minutes after test product intake
Systolic Blood Pressure Sitting
Systolic blood pressure measured while sitting
Measured: Before and 90 minutes after test product intake
Diastolic Blood Pressure Sitting
Diastolic blood pressure measured while sitting
Measured: Before and 90 minutes after test product intake
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Vascular 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
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- King's College London
- Responsible party
- Sponsor
- Investigators
- Phillip Chowienczyk, Professor, Principal investigator, Dept Clinical Pharmacology/CRF, St Thomas Hospital, London UK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02273323
- Sponsor's protocol ID
- REF-BEV-1376
- Acronym
- T
- Status last verified
- Dec 2016
- First submitted
- 21 Oct 2014
- Last updated
- 15 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Flow Mediated Dilation in Response to Consumption of Black Tea Versus Artificial Tea, in Non-tea Drinking Hypertensive Subjects.
- ClinicalTrials.gov ID
- NCT02273323
- Acronym / sponsor ID
- T / REF-BEV-1376
- Conditions
- Vascular Function
- Keywords
- Flow mediated dilation, tea, blood pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- King's College London
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 23 Oct 2014 (estimated)
- Results
- Posted 15 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Research indicate that people who regularly drink tea have a reduced risk of stroke or heart disease. In a number of studies in which people that normally do not drink showed that their blood vessels function improved when the drunk tea. The current study tests whether a specific black tea improves vessel function in non-tea drinking hypertensive subjects.
Detailed description
Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction. In a number of previous nutrition intervention studies tea has been shown to improve vascular function as assessed by Flow Mediated Dilation in various populations. The current confirmatory study tests a specific black tea against a placebo in a population of in non-tea drinking hypertensive subjects.
Study design
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tea | Experimental | Other: TeaBlack tea |
| Placebo | Placebo comparator | Other: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Males and post menopausal (> 1 year) females, not on hormone replacement therapy
- Aged >18 and < 65 years
- Body mass index (BMI) of >=18.0 and =<35.0 kg/m2
- Hypertension as previously diagnosed by primary care or hospital physician.
Key exclusion criteria (10 listed)
- Tea drinkers: having typically consumed > 1 cup of black tea per week.
- Current smoker or has stopped smoking less than 6 months before start of study
- Self reported alcohol intake of >21 units/week
- Established cardiovascular disease other than hypertension
- Clinically significant arrhythmia
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 |
|---|---|---|
| TeaSingle dose of black tea infusion containing approximately 400 mg flavonoids (expressed as gallic acid equivalents) with added sugar. | Other | Tea |
| PlaceboPlacebo: tea flavour, colouring and sugar | Other | Placebo |
Primary outcome
Flow Mediated Dilation
Time frame: Before and 2 hours after test product intake
Flow mediated dilation (FMD) of the brachial artery was measured using vascular ultra sound and automated edge detection software: * 1 minute baseline scan to measure the baseline diameter of artery * 5 minutes of forearm occlusion at 250±30 mmHg, below the elbow (2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion Percentage FMD was calculated as the maximum increase in diameter after cuff release relative to the baseline diameter
5 secondary outcomes
Endothelium-independent Vasodilation
Time frame: 2.5 hours after test product intake
Systolic Blood Pressure Supine
Time frame: Before and 110 minutes after test product intake
Diastolic Blood Pressure Supine
Time frame: Before and 110 minutes after test product intake
Systolic Blood Pressure Sitting
Time frame: Before and 90 minutes after test product intake
Diastolic Blood Pressure Sitting
Time frame: Before and 90 minutes after test product intake
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Phillip Chowienczyk, Professor principal investigator
Dept Clinical Pharmacology/CRF, St Thomas Hospital, London UK
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tea in people with Vascular Function, run by Unilever R&D 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 10 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 15 Feb 2017. 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?
Yes. Results are posted in the registry (first posted 15 Feb 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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: Before and 2 hours after test product intake). 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 15 Feb 2017.