NCT02298530

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
56

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 12, 2014

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 24, 2014

Completed
3 months until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

December 4, 2015

Status Verified

December 1, 2015

Enrollment Period

7 months

First QC Date

November 12, 2014

Last Update Submit

December 3, 2015

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Systolic blood pressure during stress

    Systolic blood pressure during acute mental stress

    Between 30-45 minutes after test product intake

Secondary Outcomes (5)

  • Diastolic blood pressure during stress

    Between 30-45 minutes after test product intake

  • Systolic blood pressure after stress

    Between 45-60 minutes after test product intake

  • Diastolic blood pressure after stress

    Between 45-60 minutes after test product intake

  • STAI before and immediately after stress

    -15 and 45 relative to test product intake

  • UWIST before and immediately after stress

    -10, 45 minutes relative to test product intake

Other Outcomes (21)

  • Cortisol in saliva before and immediately after stress

    -5, 45 min relative to test product intake

  • Heart rate during stress

    Between 30-45 minutes after test product intake

  • Heart rate after stress

    Between 45-60 minutes after test product intake

  • +18 more other outcomes

Study Arms (2)

Combination of caffeine and theanine

EXPERIMENTAL

250 mg caffeine + 200 mg theanine

Other: Combination of caffeine and theanine

Caffeine

PLACEBO COMPARATOR

250 mg caffeine

Other: Caffeine

Interventions

Combination of caffeine and theanineOTHER

Beverage containing caffeine and theanine

Combination of caffeine and theanine
CaffeineOTHER

Beverage containing caffeine

Caffeine

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Apparently healthy males and females
  • Women taking the contraceptive pill
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University College London

London, United Kingdom

Location

MeSH Terms

Interventions

theanineCaffeine

Intervention Hierarchy (Ancestors)

XanthinesAlkaloidsHeterocyclic CompoundsPurinonesPurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Mark Hamer, Dr

    UCL, Epidemiology & Public Health, London

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 12, 2014

First Posted

November 24, 2014

Study Start

March 1, 2015

Primary Completion

October 1, 2015

Study Completion

November 1, 2015

Last Updated

December 4, 2015

Record last verified: 2015-12

Locations

GB(1)