Tea Components, Mental Stress and Blood Pressure

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02298530
• Other study ID #: REF-BEV-1803
• Status: Completed
• Phase: N/A
• First received: November 12, 2014
• Last updated: December 3, 2015
• Start date: March 2015
• Est. completion date: November 2015

Study information

• Verified date: December 2015
• Source: Unilever R&D
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: November 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy
• Stress, Psychological

Intervention

Other:
• Combination of caffeine and theanine
Beverage containing caffeine and theanine
• Caffeine
Beverage containing caffeine

Locations

Country	Name	City	State
United Kingdom	University College London	London

Sponsors (2)

Lead Sponsor	Collaborator
Unilever R&D	University College, London

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cortisol in saliva before and immediately after stress	Concentration of cortisol in saliva	-5, 45 min relative to test product intake	No
Other	Heart rate during stress	Heart rate during acute mental stress	Between 30-45 minutes after test product intake	No
Other	Heart rate after stress	Heart rate immediately after acute mental stress	Between 45-60 minutes after test product intake	No
Other	Heart rate variability during stress	Heart rate variability during acute mental stress	Between 30-45 minutes after test product intake	No
Other	Heart rate variability after stress	Heart rate variability immediately after acute mental stress	Between 45-60 minutes after test product intake	No
Other	Performance STROOP	Task performance on STROOP task	Between 30-45 minutes after test product intake	No
Other	Performance mirror tracing	Task performance on mirror tracing task	Between 30-45 minutes after test product intake	No
Other	Systolic blood pressure, free living phase	Ambulatory systolic blood pressure during free living phase	Between 80-270 minutes after test product intake	No
Other	Diastolic blood pressure, free living phase	Ambulatory diastolic blood pressure during free living phase	Between 80-270 minutes after test product intake	No
Other	Cortisol, free living phase	Concentration of cortisol in saliva during free living phase	140, 200 and 260 minutes after test product intake	No
Other	STAI, free living phase	Self-reported mental state: State-Trait Anxiety Inventory during free living phase	140, 200 and 260 minutes after test product intake	No
Other	UWIST, free living phase	Self-reported mental state: University Of Wales Institute of Science and Technology) mood adjective questionnaire during free living phase	140, 200 and 260 minutes after test product intake	No
Other	Pulse pressure during stress	Mean pulse pressure during mental stress	Between 30-45 minutes after test product intake	No
Other	Pulse pressure after stress	Mean pulse pressure after acute mental stress	Between 45-60 minutes after test product intake	No
Other	Mental wellbeing	Mental well being as assessed by on line survey an each evening during the 7 day period the accelerometer is worn.	7 consecutive days prior to the lab sessions	No
Other	Physical activity	Habitual patterns in physical activity as measured by accelerometer	7 consecutive days prior to the lab sessions	No
Other	STAI screening	State-Trait Anxiety Inventory (STAI) - Trait version, covariate	Screening	No
Other	CES-D	Center for Epidemiologic Studies Depression scale, covariate	Screening	No
Other	CISS	CISS coping scale, covariate	Screening	No
Other	loneliness	UCLA loneliness scale, covariate	Screening	No
Other	Perceived stress	Perceived Stress Scale, covariate	Screening	No
Primary	Systolic blood pressure during stress	Systolic blood pressure during acute mental stress	Between 30-45 minutes after test product intake	No
Secondary	Diastolic blood pressure during stress	Diastolic blood pressure during acute mental stress	Between 30-45 minutes after test product intake	No
Secondary	Systolic blood pressure after stress	Systolic blood pressure immediately after acute mental stress	Between 45-60 minutes after test product intake	No
Secondary	Diastolic blood pressure after stress	Diastolic blood pressure immediately after acute mental stress	Between 45-60 minutes after test product intake	No
Secondary	STAI before and immediately after stress	Self-reported mental state: State-Trait Anxiety Inventory	-15 and 45 relative to test product intake	No
Secondary	UWIST before and immediately after stress	Self-reported mental state: University Of Wales Institute of Science and Technology mood adjective questionnaire	-10, 45 minutes relative to test product intake	No