HealthyNCT02298530
Tea Components, Mental Stress and Blood Pressure
A study testing Combination of caffeine and theanine and Caffeine in people with Healthy, run by Unilever R&D at 1 site in United Kingdom.
Trial summary
Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Combination of caffeine and theanine and Caffeine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 56 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2015to Nov 2015
- 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 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Apparently healthy males and females
- Women taking the contraceptive pill
- 18-45 years of age
- BMI 20-30 kg/m2
- Normal or corrected vision
- Low caffeine consumers (<100mg/day)
Show all 9Show fewer
- Non smokers and having been a non-smoker for > 6 months
- Fluent English
- Normotensive (>90/60 <140/90 mmHg)
Who cannot join
- Significant current or medical history of cardiovascular disease
- Low or high STAI trait score in the opinion of the PI
- Known sensitivity to caffeine or theanine
- Colour blindness
- Alcohol consumption above 14/21 units female/male resp. per week
- Weight loss diet > 10% of bodyweight in the previous year
- Anyone with a dependency on PI or staff of Department of Epidemiology and Public Health or being an employee of Unilever
- Reported participation in another biomedical study < 3 months before screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Study to Determine the Acute Effects of a Tea Component on Blood Pressure and Mental Stress Challenge
Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.
Read the detailed description
Caffeine and (mental) stress can increase blood pressure. In a typical everyday and/or work environment they commonly coincide. Tea has the reputation of being a relaxing drink. L-theanine is an amino acid found almost exclusively in tea. In a previous study it was shown that caffeine increased blood pressure, while theanine antagonised these effects. In the current study the effect of theanine to a placebo on blood pressure are directly compared.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combination of caffeine and theanineOther
Beverage containing caffeine and theanine
CaffeineOther
Beverage containing caffeine
| Study group | Role | What they receive |
|---|---|---|
| Combination of caffeine and theanine | Experimental | 250 mg caffeine + 200 mg theanine Receives: Other: Combination of caffeine and theanine |
| Caffeine | Placebo comparator | 250 mg caffeine Receives: Other: Caffeine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Systolic blood pressure during stress
Systolic blood pressure during acute mental stress
Measured: Between 30-45 minutes after test product intake
Secondary outcomes (5)
Diastolic blood pressure during stress
Diastolic blood pressure during acute mental stress
Measured: Between 30-45 minutes after test product intake
Systolic blood pressure after stress
Systolic blood pressure immediately after acute mental stress
Measured: Between 45-60 minutes after test product intake
Diastolic blood pressure after stress
Diastolic blood pressure immediately after acute mental stress
Measured: Between 45-60 minutes after test product intake
STAI before and immediately after stress
Self-reported mental state: State-Trait Anxiety Inventory
Measured: -15 and 45 relative to test product intake
UWIST before and immediately after stress
Self-reported mental state: University Of Wales Institute of Science and Technology mood adjective questionnaire
Measured: -10, 45 minutes relative to 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 posted24 Nov 2014 (estimated)
- Study startMar 2015
- Primary completionOct 2015
- Study completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Unilever R&D
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University College, London
- Responsible party
- Sponsor
- Investigators
- Mark Hamer, Dr, Principal investigator, UCL, Epidemiology & Public Health, London
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02298530
- Sponsor's protocol ID
- REF-BEV-1803
- Status last verified
- Dec 2015
- First submitted
- 12 Nov 2014
- Last updated
- 4 Dec 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Determine the Acute Effects of a Tea Component on Blood Pressure and Mental Stress Challenge
- ClinicalTrials.gov ID
- NCT02298530
- Acronym / sponsor ID
- REF-BEV-1803
- Conditions
- Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Unilever R&DIndustry (pharma, biotech, devices)
- Collaborators
- University College, London
- Study start
- Mar 2015
- Primary completion
- Oct 2015 (actual)
- Study completion
- Nov 2015 (actual)
- First posted
- 24 Nov 2014 (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.
Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.
Detailed description
Caffeine and (mental) stress can increase blood pressure. In a typical everyday and/or work environment they commonly coincide. Tea has the reputation of being a relaxing drink. L-theanine is an amino acid found almost exclusively in tea. In a previous study it was shown that caffeine increased blood pressure, while theanine antagonised these effects. In the current study the effect of theanine to a placebo on blood pressure are directly compared.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination of caffeine and theanine | Experimental | Other: Combination of caffeine and theanine250 mg caffeine + 200 mg theanine |
| Caffeine | Placebo comparator | Other: Caffeine250 mg caffeine |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Apparently healthy males and females
- Women taking the contraceptive pill
- 18-45 years of age
- BMI 20-30 kg/m2
- Normal or corrected vision
Key exclusion criteria (8 listed)
- Significant current or medical history of cardiovascular disease
- Low or high STAI trait score in the opinion of the PI
- Known sensitivity to caffeine or theanine
- Colour blindness
- Alcohol consumption above 14/21 units female/male resp. per week
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 |
|---|---|---|
| Combination of caffeine and theanineBeverage containing caffeine and theanine | Other | Combination of caffeine and theanine |
| CaffeineBeverage containing caffeine | Other | Caffeine |
Primary outcome
Systolic blood pressure during stress
Time frame: Between 30-45 minutes after test product intake
Systolic blood pressure during acute mental stress
5 secondary outcomes
Diastolic blood pressure during stress
Time frame: Between 30-45 minutes after test product intake
Systolic blood pressure after stress
Time frame: Between 45-60 minutes after test product intake
Diastolic blood pressure after stress
Time frame: Between 45-60 minutes after test product intake
STAI before and immediately after stress
Time frame: -15 and 45 relative to test product intake
UWIST before and immediately after stress
Time frame: -10, 45 minutes relative to test product intake
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 Dec 2015.
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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.
Mark Hamer, Dr principal investigator
UCL, Epidemiology & Public Health, London
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Combination of caffeine and theanine and Caffeine in people with Healthy, 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 9 inclusion and 8 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 Dec 2015. 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?
Systolic blood pressure during stress (time frame: Between 30-45 minutes 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 4 Dec 2015; AzTrials last refreshed its copy on 6 Nov 2026.