Assessment of anti-stress, behavioural, and neurophysiological effects of L-theanine: A randomised, double-blind, placebo-controlled, crossover trial

Phase 4

Completed

• Conditions: Neurophysiological function; Mental Health - Studies of normal psychology, cognitive function and behaviour; Cognitive function; Stress and mood reactivity

• Registration Number: ACTRN12614000826640
• Lead Sponsor: Swinburne University of Technology

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-08-04
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 34

Inclusion Criteria

1. Male or female.
2. Aged 18-40 years.
3. Willing and able to provide written informed consent.
4. Understands and is willing and able to comply with all study procedures.
5. Fluent in written and spoken English.
6. Are in good general health with no history of psychiatric disease.
7. Must have normal, or corrected to normal vision
8. Participants must be right handed. This is for ease of analysis of the MEG data. There are hemispheric differences in terms of structure and function between right and left handed individuals that prove to be problematic when analysing the output. Given that this investigation will employ a method where participants need to press buttons as a response (in turn involving the motor cortex), it is wise to use an all right handed population.

Exclusion Criteria

1. Females who are pregnant or breast-feeding
2. Individuals currently taking medication (other than the contraceptive pill).
3. Any significant concurrent illness including any bleeding disorders, heart conditions, diabetes, glaucoma, high blood pressure or osteoporosis.
4. Individuals who suffer from Diabetes Mellitus.
5. Any known or suspected food allergies (this would cover all ingredients in the investigational product).
6. Smokers and users of recreational drugs (except alcohol and other food grade actives)
7. Have participated in any other study involving an investigational product in the last 4 weeks.
8. Metal implants (for safety in MRI and MEG)
9. Have undergone an MRI scan within the previous 7 days
10. Individuals who suffer from claustrophobia
11. Individuals who are colour blind

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress (using Visual Analogue Mood Scales)[Baseline, 30 minutes post dose, 180 minutes post dose]

Secondary Outcome Measures

Name	Time	Method
Cognitive function using Purple Multitasking Framework, attentional cuing task performance<br>[Baseline, 30 minutes post dose, 180 minutes post dose];Neurophysiological function using Magnetoencephalography (MEG) Alpha band (8-14Hz) oscillatory activity during rest and completion of attentional cuing task<br>[30 minutes post dose];Saliva measures using salivary cortisol[Baseline, 30 minutes post dose, 180 minutes post dose]