Vascular FunctionHeraclitusNCT01945970
Effect of Black Tea on Vascular Function
A study testing Black tea extract in people with Vascular Function, run by Unilever R&D at 1 site in Italy.
Trial summary
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 (FMD). Read more about this study
- Who is it for?
- Ages 40 to 65 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Vascular Function
- What is being tested?
- Black tea extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- Sep 2013to Dec 2013
- 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 40 to 65 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Apparently healthy male volunteers with no history of cardiovascular disease
- Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive)
- Non-smokers (> 2 years)
- Non-tea drinkers (less or equal 1 cup/week)
- Limited alcohol intake (less or equal 21 units/week)
- Systolic blood pressure less or equal 160 mmHg and/or diastolic blood pressure less or equal 100 mmHg at screening
- Brachial artery can be imaged using ultrasound and at screening FMD value is within the expected range as judged by the PI
- Judged to be in good health on the basis of medical history, physical examination and routine laboratory tests (total cholesterol, HDL cholesterol, LDL cholesterol, triglycerides, glucose, highly sensitive C-reactive protein).
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Italy1 site
Azienda Ospedaliero-Universitaria Pisana, Centro di Farmacologia Clinicaper la Sperimentazione dei Farmaci
Pisa
About this study
Official title: Randomized Double Blind Placebo Controlled Crossover Study to Assess the Effect of Black Tea on Flow-Mediated Dilation in Healthy, Non-tea Drinking Males
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 (FMD).
Read the detailed description
The current study tests a specific Black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea extract that has previously been shown to improve FMD is included as the positive control.
- Conditions
- Vascular Function
- Being tested
- Black tea extract, Positive control, Placebo
- Keywords
- Vascular function, Flow mediated dilation, Tea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Black tea extractOther
Black tea extract
Positive controlOther
Positive control
PlaceboOther
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Black tea extract | Experimental | Spray dried aqueous extract of a representative batch of black tea Receives: Other: Black tea extract |
| Positive control | Active comparator | Spray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously Receives: Other: Positive control |
| Placebo | Placebo comparator | Food grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Flow Mediated Dilation, Acute-upon-chronic, Black Tea
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption on day 1 to 2 hours post consumption on day 8.
Secondary outcomes (5)
Flow Mediated Dilation, Acute, Black Tea
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption on day 1 to 2 hours post consumption on day 1
Flow Mediated Dilation, Chronic, Black Tea
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption day 1 to before consumption day 8.
Flow Mediated Dilation, Acute-upon-chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption on day 1 to 2 hours post consumption on day 8
Flow Mediated Dilation, Acute, Positive Control
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption on day 1 to 2 hours post consumption on day 1
Flow Mediated Dilation, Chronic, Positive Control
Flow mediated dilation (FMD) measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (Resting stage)
- 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease)
- 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage)
- When the artery had returned to baseline a second 1 minute scan was taken
- 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject
- 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
Measured: From before consumption on day 1 to before consumption day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2013 (estimated)
- Study startSep 2013
- Primary completionNov 2013
- Study completionDec 2013
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
- Primary purpose
- Basic science
- 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
- Sprim Advanced Life Sciences
- Responsible party
- Sponsor
- Investigators
- Lorenzo Ghiadoni, MD, Principal investigator, University of Pisa, Internal medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945970
- Sponsor's protocol ID
- REF-BEV-1134
- Acronym
- Heraclitus
- Status last verified
- Feb 2017
- First submitted
- 8 Sep 2013
- Last updated
- 22 Mar 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double Blind Placebo Controlled Crossover Study to Assess the Effect of Black Tea on Flow-Mediated Dilation in Healthy, Non-tea Drinking Males
- ClinicalTrials.gov ID
- NCT01945970
- Acronym / sponsor ID
- Heraclitus / REF-BEV-1134
- Conditions
- Vascular Function
- Keywords
- Vascular function, Flow mediated dilation, Tea
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Sprim Advanced Life Sciences
- Study start
- Sep 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 19 Sep 2013 (estimated)
- Results
- Posted 17 Feb 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 (FMD).
Detailed description
The current study tests a specific Black tea extract against a placebo in population that has previously show to be sensitive to the effect of black tea on Flow Mediated dilation. A tea extract that has previously been shown to improve FMD is included as the positive control.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Black tea extract | Experimental | Other: Black tea extractSpray dried aqueous extract of a representative batch of black tea |
| Positive control | Active comparator | Other: Positive controlSpray dried aqueous extract of a batch of tea extract that has shown to improve FMD previously |
| Placebo | Placebo comparator | Other: PlaceboFood grade colouring, artificial tea flavour and an amount of caffeine matched to the caffeine in the Black tea extract |
Who may qualify
- Ages
- 40 to 65 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Apparently healthy male volunteers with no history of cardiovascular disease
- Having body mass index (BMI) of between 18.0 and 30.0 kg/m2 (inclusive)
- Non-smokers (> 2 years)
- Non-tea drinkers (less or equal 1 cup/week)
- Limited alcohol intake (less or equal 21 units/week)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Black tea extractBlack tea extract | Other | Black tea extract |
| Positive controlPositive control | Other | Positive control |
| PlaceboPlacebo | Other | Placebo |
Primary outcome
Flow Mediated Dilation, Acute-upon-chronic, Black Tea
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8.
Flow mediated dilation (FMD) measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (Resting stage) * 5 minutes of forearm occlusion at 300±30 mmHg (cuff occlusion stage), just below the elbow 2-5 cm from antecubital crease) * 4 minutes FMD scan, which started immediately after release of occlusion (reactive hyperaemia stage) * When the artery had returned to baseline a second 1 minute scan was taken * 25 µg sublingual glyceryl trinitrate (GTN) was given to the subject * 5 minutes GTN scan to assess the endothelium-independent dilation FMD and response to GTN was calculated as maximal percent increase in diameter above baseline (mean value of measures obtained during 1 minute before cuff inflation).
5 secondary outcomes
Flow Mediated Dilation, Acute, Black Tea
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
Flow Mediated Dilation, Chronic, Black Tea
Time frame: From before consumption day 1 to before consumption day 8.
Flow Mediated Dilation, Acute-upon-chronic, Positive Control
Time frame: From before consumption on day 1 to 2 hours post consumption on day 8
Flow Mediated Dilation, Acute, Positive Control
Time frame: From before consumption on day 1 to 2 hours post consumption on day 1
Flow Mediated Dilation, Chronic, Positive Control
Time frame: From before consumption on day 1 to before consumption day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lorenzo Ghiadoni, MD principal investigator
University of Pisa, Internal medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Black tea extract in people with Vascular Function, run by Unilever R&D at 1 site in Italy.
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 8 inclusion and 0 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 22 Mar 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 Italy. 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 17 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, Acute-upon-chronic, Black Tea (time frame: From before consumption on day 1 to 2 hours post consumption on day 8.). 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 22 Mar 2017.