HealthyNCT01561300
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
A study testing Nutrition intervention study with a black tea extract in people with Healthy, run by Unilever R&D at 1 site in India.
Trial summary
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males. Read more about this study
- Who is it for?
- Ages 30 to 50 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Nutrition intervention study with a black tea extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteIndia
- Study dates
- Mar 2012to May 2012
- 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 30 to 50 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male volunteers aged between >_30 _< 50 years of age
- Body Mass Index (BMI) of >_18 and _< 25.0 kg/m2
- Systolic blood pressure >_140 and >_100 mmHg and diastolic blood pressure < 90 and > 70 mmHg
- Subjects who consume _< 2 cups of coffee per day
- Subjects who drink tea regularly (>_ 2 cups per day)
- Apparently healthy, with no reported medical condition which might affect the assessment as judged by the study physician or/and PI
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- No prescribed medical treatment that may affect study parameters as judged by the Study Physician
- Subject willing to abstain from alcohol on day before and on the day of assessment
- Willing to sign the informed consent form
Who cannot join
- Smokers and/or tobacco chewers
- Those who consume regular alcohol (> 160 ml of alcohol per week)
- Reported intense sport activities > 10h/week
- Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
Read the detailed description
Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.
- Conditions
- Healthy
- Being tested
- Nutrition intervention study with a black tea extract, Nutrition intervention study with a control
- Keywords
- Black tea, Flow Mediated Dilation, Vascular function, India
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nutrition intervention study with a black tea extractOther
Also called Black tea extract
Tea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water.
Products will be consumed for 8 days. On measurement days tea will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
On day 2-7 subjects will consume 3 cups or tea, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added.
Nutrition intervention study with a controlOther
Also called Control
Control: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water.
Products will be consumed for 8 days. On measurement days control will be given to the subjects as a single acute dose and 2 grams of sugar will be added.
On day 2-7 subjects will consume 3 cups of control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added.
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Nutrition intervention study with a control Receives: Other: Nutrition intervention study with a control |
| Tea extract | Experimental | Nutrition intervention study with a black tea extract Receives: Other: Nutrition intervention study with a black tea extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
'Acute-upon-chronic Effect' of Tea vs Control
Change in flow mediated dilation (FMD) due to tea consumption when compared to control.
FMD measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (baseline)
- 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
- 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Measured: Baseline day 1 to 2 hours post consumption on day 8.
Secondary outcomes (2)
Acute Effect of Tea vs Control
Change in flow mediated dilation due to tea consumption when compared to control.
FMD measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (baseline)
- 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
- 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Measured: From baseline on day 1 to 2 hours post consumption on day 1
Chronic Effect of Tea vs Control
Change in flow mediated dilation (FMD) due to tea consumption when compared to control.
FMD measurement included the following steps:
- 1 minute base scan to measure the baseline diameter of artery (baseline)
- 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease
- 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
Measured: From baseline at day 1 to baseline on day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionApr 2012
- Study completionMay 2012
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 HealthyStudies 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
- Other
- 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
- Lotus Labs Pvt. Ltd, Bangalore, India, Clumax Diagnostics, Bangalore, India, Quipu S.r.l, Pisa, Italy
- Responsible party
- Sponsor
- Investigators
- Anisha Pargal, Dr, Study director, Unilever Industries Pvt. Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01561300
- Sponsor's protocol ID
- FDS-BEV-0284
- Status last verified
- Feb 2017
- First submitted
- 20 Mar 2012
- Last updated
- 5 Apr 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 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Standardized Brooke Bond Black Tea Extract on Flow-Mediated Dilation After an Acute Dose as Well as After One Week of Consumption in Healthy Adult Indian Males
- ClinicalTrials.gov ID
- NCT01561300
- Acronym / sponsor ID
- FDS-BEV-0284
- Conditions
- Healthy
- Keywords
- Black tea, Flow Mediated Dilation, Vascular function, India
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- Lotus Labs Pvt. Ltd, Bangalore, India, Clumax Diagnostics, Bangalore, India, Quipu S.r.l, Pisa, Italy
- Study start
- Mar 2012
- Primary completion
- Apr 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 23 Mar 2012 (estimated)
- Results
- Posted 5 Apr 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
Detailed description
Flow mediated dilation (FMD) is a non-invasive measurement technique performed using ultrasound equipment to measure hyperaemia induced dilation of blood vessels. Evidence from prospective studies suggests that FMD is independently inversely associated with cardiovascular events.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Other: Nutrition intervention study with a controlNutrition intervention study with a control |
| Tea extract | Experimental | Other: Nutrition intervention study with a black tea extractNutrition intervention study with a black tea extract |
Who may qualify
- Ages
- 30 to 50 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Male volunteers aged between >_30 _< 50 years of age
- Body Mass Index (BMI) of >_18 and _< 25.0 kg/m2
- Systolic blood pressure >_140 and >_100 mmHg and diastolic blood pressure < 90 and > 70 mmHg
- Subjects who consume _< 2 cups of coffee per day
- Subjects who drink tea regularly (>_ 2 cups per day)
Key exclusion criteria (4 listed)
- Smokers and/or tobacco chewers
- Those who consume regular alcohol (> 160 ml of alcohol per week)
- Reported intense sport activities > 10h/week
- Participating in any other clinical study concurrently or if participated in any study during 2 months preceding the screening visit
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 |
|---|---|---|
| Nutrition intervention study with a black tea extractAlso: Black tea extractTea extract: 1800 mg/day standardized Brooke Bond black tea extract equivalent to 400 mg flavonoids dissolved in 240 ml hot water. Products will be consumed for 8 days. On measurement days tea will be given to the subjects as a single acute dose and 2 grams of sugar will be added. On day 2-7 subjects will consume 3 cups or tea, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added. | Other | Tea extract |
| Nutrition intervention study with a controlAlso: ControlControl: 1800 mg/day of a powder that gives a flavoured beverage with a color similar to black tea dissolved in 240 ml hot water. Products will be consumed for 8 days. On measurement days control will be given to the subjects as a single acute dose and 2 grams of sugar will be added. On day 2-7 subjects will consume 3 cups of control, each prepared with 800 mg product in 80 ml of boiling water and sugar added to subject's taste. First cup of tea will be taken as morning tea, 2nd at breakfast and 3rd in the evening. No milk will be added. | Other | Control |
Primary outcome
'Acute-upon-chronic Effect' of Tea vs Control
Time frame: Baseline day 1 to 2 hours post consumption on day 8.
Change in flow mediated dilation (FMD) due to tea consumption when compared to control. FMD measurement included the following steps: * 1 minute base scan to measure the baseline diameter of artery (baseline) * 5 minutes of forearm occlusion at 300±30 mmHg, just below the elbow 2-5 cm from antecubital crease * 4 minutes FMD scan, which started immediately after release of the occlusion (reactive hyperaemia stage) FMD was calculated as maximal percentage change in diameter of the artery above the baseline value after the release of the occlusion
2 secondary outcomes
Acute Effect of Tea vs Control
Time frame: From baseline on day 1 to 2 hours post consumption on day 1
Chronic Effect of Tea vs Control
Time frame: From baseline at day 1 to baseline on day 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 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.
Anisha Pargal, Dr study director
Unilever Industries Pvt. Ltd
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nutrition intervention study with a black tea extract in people with Healthy, run by Unilever R&D at 1 site in India.
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 9 inclusion and 4 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 5 Apr 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 India. 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 5 Apr 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?
'Acute-upon-chronic Effect' of Tea vs Control (time frame: Baseline 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 5 Apr 2017.