NCT01851122

Brief Summary

The amino acid l-theanine (the active ingredient in green tea) is considered to have a calming effect without causing sleepiness. This study evaluates whether l-theanine affects blood pressure, heart rate, alertness, and sense of well-being.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2011

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

Study Start

First participant enrolled

November 1, 2011

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2012

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 3, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 10, 2013

Completed
Last Updated

December 13, 2023

Status Verified

December 1, 2023

Enrollment Period

11 months

First QC Date

May 3, 2013

Last Update Submit

December 5, 2023

Conditions

Theanine, (L)-Isomer

Keywords

l-theaninealertnesswell-being

Outcome Measures

Primary Outcomes (3)

  • Alertness

    The average response time to identify a small rectangle shown on a computer screen.

    48 hrs

  • Alertness

    Degree of subjective alertness, measured on a visual analog scale

    48 hrs

  • Well-Being

    Sense of subjective well-being as measured on a visual analog scale

    48 hrs

Study Arms (2)

Placebo capsule

PLACEBO COMPARATOR
Dietary Supplement: Placebo capsule

L-theanine capsule

EXPERIMENTAL
Dietary Supplement: L-theanine capsule

Interventions

L-theanine capsuleDIETARY_SUPPLEMENT

L-theanine 250mg capsule

L-theanine capsule
Placebo capsuleDIETARY_SUPPLEMENT
Placebo capsule

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adult
  • able to swallow capsule

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Physicians at Sugar Creek

Sugar Land, Texas, 77478, United States

Location

MeSH Terms

Interventions

theanine

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Staff - Internal Medicine - Cardiology

Study Record Dates

First Submitted

May 3, 2013

First Posted

May 10, 2013

Study Start

November 1, 2011

Primary Completion

October 1, 2012

Study Completion

October 1, 2012

Last Updated

December 13, 2023

Record last verified: 2023-12

Locations

US(1)