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Tea Components, Mental Stress and Blood Pressure

Primary Purpose

Healthy

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Combination of caffeine and theanine
Caffeine
Sponsored by
Unilever R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Healthy

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University College London

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Combination of caffeine and theanine

Caffeine

Arm Description

250 mg caffeine + 200 mg theanine

250 mg caffeine

Outcomes

Primary Outcome Measures

Systolic blood pressure during stress
Systolic blood pressure during acute mental stress

Secondary Outcome Measures

Diastolic blood pressure during stress
Diastolic blood pressure during acute mental stress
Systolic blood pressure after stress
Systolic blood pressure immediately after acute mental stress
Diastolic blood pressure after stress
Diastolic blood pressure immediately after acute mental stress
STAI before and immediately after stress
Self-reported mental state: State-Trait Anxiety Inventory
UWIST before and immediately after stress
Self-reported mental state: University Of Wales Institute of Science and Technology mood adjective questionnaire

Full Information

First Posted
November 12, 2014
Last Updated
December 3, 2015
Sponsor
Unilever R&D
Collaborators
University College, London
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1. Study Identification

Unique Protocol Identification Number
NCT02298530
Brief Title
Tea Components, Mental Stress and Blood Pressure
Official Title
A Study to Determine the Acute Effects of a Tea Component on Blood Pressure and Mental Stress Challenge
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
November 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Unilever R&D
Collaborators
University College, London

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Combination of caffeine and theanine
Arm Type
Experimental
Arm Description
250 mg caffeine + 200 mg theanine
Arm Title
Caffeine
Arm Type
Placebo Comparator
Arm Description
250 mg caffeine
Intervention Type
Other
Intervention Name(s)
Combination of caffeine and theanine
Intervention Description
Beverage containing caffeine and theanine
Intervention Type
Other
Intervention Name(s)
Caffeine
Intervention Description
Beverage containing caffeine
Primary Outcome Measure Information:
Title
Systolic blood pressure during stress
Description
Systolic blood pressure during acute mental stress
Time Frame
Between 30-45 minutes after test product intake
Secondary Outcome Measure Information:
Title
Diastolic blood pressure during stress
Description
Diastolic blood pressure during acute mental stress
Time Frame
Between 30-45 minutes after test product intake
Title
Systolic blood pressure after stress
Description
Systolic blood pressure immediately after acute mental stress
Time Frame
Between 45-60 minutes after test product intake
Title
Diastolic blood pressure after stress
Description
Diastolic blood pressure immediately after acute mental stress
Time Frame
Between 45-60 minutes after test product intake
Title
STAI before and immediately after stress
Description
Self-reported mental state: State-Trait Anxiety Inventory
Time Frame
-15 and 45 relative to test product intake
Title
UWIST before and immediately after stress
Description
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 Pre-specified Outcome Measures:
Title
Cortisol in saliva before and immediately after stress
Description
Concentration of cortisol in saliva
Time Frame
-5, 45 min relative to test product intake
Title
Heart rate during stress
Description
Heart rate during acute mental stress
Time Frame
Between 30-45 minutes after test product intake
Title
Heart rate after stress
Description
Heart rate immediately after acute mental stress
Time Frame
Between 45-60 minutes after test product intake
Title
Heart rate variability during stress
Description
Heart rate variability during acute mental stress
Time Frame
Between 30-45 minutes after test product intake
Title
Heart rate variability after stress
Description
Heart rate variability immediately after acute mental stress
Time Frame
Between 45-60 minutes after test product intake
Title
Performance STROOP
Description
Task performance on STROOP task
Time Frame
Between 30-45 minutes after test product intake
Title
Performance mirror tracing
Description
Task performance on mirror tracing task
Time Frame
Between 30-45 minutes after test product intake
Title
Systolic blood pressure, free living phase
Description
Ambulatory systolic blood pressure during free living phase
Time Frame
Between 80-270 minutes after test product intake
Title
Diastolic blood pressure, free living phase
Description
Ambulatory diastolic blood pressure during free living phase
Time Frame
Between 80-270 minutes after test product intake
Title
Cortisol, free living phase
Description
Concentration of cortisol in saliva during free living phase
Time Frame
140, 200 and 260 minutes after test product intake
Title
STAI, free living phase
Description
Self-reported mental state: State-Trait Anxiety Inventory during free living phase
Time Frame
140, 200 and 260 minutes after test product intake
Title
UWIST, free living phase
Description
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
Title
Pulse pressure during stress
Description
Mean pulse pressure during mental stress
Time Frame
Between 30-45 minutes after test product intake
Title
Pulse pressure after stress
Description
Mean pulse pressure after acute mental stress
Time Frame
Between 45-60 minutes after test product intake
Title
Mental wellbeing
Description
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
Title
Physical activity
Description
Habitual patterns in physical activity as measured by accelerometer
Time Frame
7 consecutive days prior to the lab sessions
Title
STAI screening
Description
State-Trait Anxiety Inventory (STAI) - Trait version, covariate
Time Frame
Screening
Title
CES-D
Description
Center for Epidemiologic Studies Depression scale, covariate
Time Frame
Screening
Title
CISS
Description
CISS coping scale, covariate
Time Frame
Screening
Title
loneliness
Description
UCLA loneliness scale, covariate
Time Frame
Screening
Title
Perceived stress
Description
Perceived Stress Scale, covariate
Time Frame
Screening

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mark Hamer, Dr
Organizational Affiliation
UCL, Epidemiology & Public Health, London
Official's Role
Principal Investigator
Facility Information:
Facility Name
University College London
City
London
Country
United Kingdom

12. IPD Sharing Statement

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Tea Components, Mental Stress and Blood Pressure

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