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Completed

NCT Number: NCT02298530

Tea Components, Mental Stress and Blood Pressure

Assess the effects of adding theanine to a caffeinated beverage on changes in blood pressure during acute mental stress.

Completed

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Key information

Conditions

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College London

London, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Combination of caffeine and theanine

Other

Beverage containing caffeine and theanine

Caffeine

Other

Beverage containing caffeine

Primary outcomes

  1. Systolic blood pressure during stress

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

    Systolic blood pressure during acute mental stress

Secondary outcomes

  1. Diastolic blood pressure during stress

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

    Diastolic blood pressure during acute mental stress

  2. Systolic blood pressure after stress

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

    Systolic blood pressure immediately after acute mental stress

  3. Diastolic blood pressure after stress

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

    Diastolic blood pressure immediately after acute mental stress

  4. STAI before and immediately after stress

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

    Self-reported mental state: State-Trait Anxiety Inventory

  5. UWIST before and immediately after stress

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

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

Other outcomes

  1. Cortisol in saliva before and immediately after stress

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

    Concentration of cortisol in saliva

  2. Heart rate during stress

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

    Heart rate during acute mental stress

  3. Heart rate after stress

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

    Heart rate immediately after acute mental stress

  4. Heart rate variability during stress

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

    Heart rate variability during acute mental stress

  5. Heart rate variability after stress

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

    Heart rate variability immediately after acute mental stress

  6. Performance STROOP

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

    Task performance on STROOP task

  7. Performance mirror tracing

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

    Task performance on mirror tracing task

  8. Systolic blood pressure, free living phase

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

    Ambulatory systolic blood pressure during free living phase

  9. Diastolic blood pressure, free living phase

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

    Ambulatory diastolic blood pressure during free living phase

  10. Cortisol, free living phase

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

    Concentration of cortisol in saliva during free living phase

  11. STAI, free living phase

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

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

  12. UWIST, free living phase

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

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

  13. Pulse pressure during stress

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

    Mean pulse pressure during mental stress

  14. Pulse pressure after stress

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

    Mean pulse pressure after acute mental stress

  15. Mental wellbeing

    Time frame: 7 consecutive days prior to the lab sessions

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

  16. Physical activity

    Time frame: 7 consecutive days prior to the lab sessions

    Habitual patterns in physical activity as measured by accelerometer

  17. STAI screening

    Time frame: Screening

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

  18. CES-D

    Time frame: Screening

    Center for Epidemiologic Studies Depression scale, covariate

  19. CISS

    Time frame: Screening

    CISS coping scale, covariate

  20. loneliness

    Time frame: Screening

    UCLA loneliness scale, covariate

  21. Perceived stress

    Time frame: Screening

    Perceived Stress Scale, covariate

Sponsors and collaborators

Lead sponsor

Unilever R&D

Industry

Collaborators

  • University College, London

Registry information

Official study title

A Study to Determine the Acute Effects of a Tea Component on Blood Pressure and Mental Stress Challenge

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2014
Registry last updated
Dec 4, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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