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CompletedNCT02298530Updated Dec 4, 2015

Tea Components, Mental Stress and Blood Pressure

An interventional study of Combination of caffeine and theanine and Caffeine in Healthy, sponsored by Unilever R&D. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-12-04.

Sponsored by Unilever R&D · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
56
Allocation
Randomized
Ages
18 Years to 45 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Healthy

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03

In context

Stress, Psychological

783 studies on the registry are indexed under Stress, Psychological; 128 are open to participants now.

This study's enrollment of 56 is below the median of 85 across 632 interventional studies indexed under Stress, Psychological.

Browse Stress, Psychological studies →

Lead sponsor

Unilever R&D is the lead sponsor of 69 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • 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)
  • Non smokers and having been a non-smoker for > 6 months
  • Fluent English
  • Normotensive (>90/60 \<140/90 mmHg)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
56 participants (actual)

Study arms

  • Experimental
    Combination of caffeine and theanine

    250 mg caffeine + 200 mg theanine

    Other: Combination of caffeine and theanine

  • Placebo comparator
    Caffeine

    250 mg caffeine

    Other: Caffeine

Interventions

  • OtherCombination of caffeine and theanine

    Beverage containing caffeine and theanine

  • OtherCaffeine

    Beverage containing caffeine

06

What researchers measure

Primary outcomes

  1. Systolic blood pressure during stress

    Systolic blood pressure during acute mental stress

    Time frame: Between 30-45 minutes after test product intake

Secondary outcomes

  1. Diastolic blood pressure during stress

    Diastolic blood pressure during acute mental stress

    Time frame: Between 30-45 minutes after test product intake

  2. Systolic blood pressure after stress

    Systolic blood pressure immediately after acute mental stress

    Time frame: Between 45-60 minutes after test product intake

  3. Diastolic blood pressure after stress

    Diastolic blood pressure immediately after acute mental stress

    Time frame: Between 45-60 minutes after test product intake

  4. STAI before and immediately after stress

    Self-reported mental state: State-Trait Anxiety Inventory

    Time frame: -15 and 45 relative to test product intake

  5. UWIST before and immediately after stress

    Self-reported mental state: University Of Wales Institute of Science and Technology mood adjective questionnaire

    Time frame: -10, 45 minutes relative to test product intake

Other outcomes

  1. Cortisol in saliva before and immediately after stress

    Concentration of cortisol in saliva

    Time frame: -5, 45 min relative to test product intake

  2. Heart rate during stress

    Heart rate during acute mental stress

    Time frame: Between 30-45 minutes after test product intake

  3. Heart rate after stress

    Heart rate immediately after acute mental stress

    Time frame: Between 45-60 minutes after test product intake

  4. Heart rate variability during stress

    Heart rate variability during acute mental stress

    Time frame: Between 30-45 minutes after test product intake

  5. Heart rate variability after stress

    Heart rate variability immediately after acute mental stress

    Time frame: Between 45-60 minutes after test product intake

  6. Performance STROOP

    Task performance on STROOP task

    Time frame: Between 30-45 minutes after test product intake

  7. Performance mirror tracing

    Task performance on mirror tracing task

    Time frame: Between 30-45 minutes after test product intake

  8. Systolic blood pressure, free living phase

    Ambulatory systolic blood pressure during free living phase

    Time frame: Between 80-270 minutes after test product intake

  9. Diastolic blood pressure, free living phase

    Ambulatory diastolic blood pressure during free living phase

    Time frame: Between 80-270 minutes after test product intake

  10. Cortisol, free living phase

    Concentration of cortisol in saliva during free living phase

    Time frame: 140, 200 and 260 minutes after test product intake

  11. STAI, free living phase

    Self-reported mental state: State-Trait Anxiety Inventory during free living phase

    Time frame: 140, 200 and 260 minutes after test product intake

  12. UWIST, free living phase

    Self-reported mental state: University Of Wales Institute of Science and Technology) mood adjective questionnaire during free living phase

    Time frame: 140, 200 and 260 minutes after test product intake

  13. Pulse pressure during stress

    Mean pulse pressure during mental stress

    Time frame: Between 30-45 minutes after test product intake

  14. Pulse pressure after stress

    Mean pulse pressure after acute mental stress

    Time frame: Between 45-60 minutes after test product intake

  15. Mental wellbeing

    Mental well being as assessed by on line survey an each evening during the 7 day period the accelerometer is worn.

    Time frame: 7 consecutive days prior to the lab sessions

  16. Physical activity

    Habitual patterns in physical activity as measured by accelerometer

    Time frame: 7 consecutive days prior to the lab sessions

  17. STAI screening

    State-Trait Anxiety Inventory (STAI) - Trait version, covariate

    Time frame: Screening

  18. CES-D

    Center for Epidemiologic Studies Depression scale, covariate

    Time frame: Screening

  19. CISS

    CISS coping scale, covariate

    Time frame: Screening

  20. loneliness

    UCLA loneliness scale, covariate

    Time frame: Screening

  21. Perceived stress

    Perceived Stress Scale, covariate

    Time frame: Screening

07

Study locations

1 site
  • University College London
    London, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 4, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02298530
Lead sponsor
Unilever R&D
Collaborators
University College, London
Responsible party
Sponsor
First posted
Nov 24, 2014
Start date
Mar 2015
Primary completion
Oct 2015
Completion
Nov 2015
Last update
Dec 4, 2015

Study contacts

Mark Hamer, Dr
principal investigator · UCL, Epidemiology & Public Health, London

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2015. You cannot join it, but the record below documents what was studied.

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