Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000826640
Ethics application status
Approved
Date submitted
28/07/2014
Date registered
4/08/2014
Date last updated
5/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Assessment of anti-stress, behavioural, and neurophysiological effects of L-theanine: A randomised, double-blind, placebo-controlled, crossover trial
Scientific title
Assessment of anti-stress, behavioural, and neurophysiological effects of L-theanine: A randomised, double-blind, placebo-controlled, crossover trial in healthy adults
Secondary ID [1] 285067 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress and mood reactivity 292594 0
Cognitive function 292595 0
Neurophysiological function 292596 0
Condition category
Condition code
Mental Health 292898 292898 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The present study will test the anti-stress, cognitive, and neurophysiological effects of acute L-theanine, Chamomile, Alpha GPC and phospholipid administration when compared to a placebo (vehicle control), using a randomised, controlled, double-blind, crossover design.

Participants will be required to attend three sessions. The first visit is a screening and practice session, assessing eligibility and familiarising participants with cognitive tasks. Finally, structural brain information will be obtained during an MRI scan. Subsequently, two testing days will be conducted a minimum of 48 hours apart. Participants will be assigned to a treatment sequence, such that one of each treatment is received across the two testing days. At testing days participants will receive a standardised lunch upon arrival, followed by a 30-minute break, then undergo baseline assessment of stress, mood, and cognitive function. After baseline assessment, treatment will be administered. 30-minutes after administration of treatment, participants will once again undergo assessment of stress, mood, and cognitive function, followed by recording of brain activity during rest and an attention task using magnetoencephalography (MEG). After this, the assessment of stress, mood, and cognitive function will be conducted a third time.

Participants will consume all interventions orally as a drink of approximately 430 ml (14.5 fl oz). Both active and vehicle control treatments contain identical ingredients of sweeteners (crystalline fructose and sucralose) and preservatives (sodium benzoate, potassium sorbate) , gum acacia and malic acid. In addition, the active treatment contains L-Theanine (200 mg, L-Tea-Active), L-Alpha Glycerylphosphorylcholine (Alpha GPC; 25 mg)), phosphatidylserine (1mg) and chamomile (10 mg).
Intervention code [1] 289905 0
Treatment: Other
Comparator / control treatment
Placebo (identical ingredients of sweeteners (crystalline fructose and sucralose) and preservatives (sodium benzoate, potassium sorbate) , gum acacia and malic acid)
Control group
Placebo

Outcomes
Primary outcome [1] 292772 0
Stress (using Visual Analogue Mood Scales)
Timepoint [1] 292772 0
Baseline, 30 minutes post dose, 180 minutes post dose
Secondary outcome [1] 309646 0
Cognitive function using Purple Multitasking Framework, attentional cuing task performance
Timepoint [1] 309646 0
Baseline, 30 minutes post dose, 180 minutes post dose
Secondary outcome [2] 309647 0
Neurophysiological function using Magnetoencephalography (MEG) Alpha band (8-14Hz) oscillatory activity during rest and completion of attentional cuing task
Timepoint [2] 309647 0
30 minutes post dose
Secondary outcome [3] 309648 0
Saliva measures using salivary cortisol
Timepoint [3] 309648 0
Baseline, 30 minutes post dose, 180 minutes post dose

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
40 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Participants responded to advertisements. After successfully completing a telephone screen, they completed a practice session where they were introduced to mood questionnaires and then practiced the computerised cognitive tasks that will be used on testing days, passed a brief medical test and informed consent was obtained. They were then given a numerical identification number and was randomly allocated to a treatment series. Participants then returned for 2 testing sessions, receiving a different treatment each visit. The person who determined if a participant was eligible for inclusion in the trial was unaware, when this decision was made, to which group the participant would be allocated. Allocation was concealed by central randomisation by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A disinterested third party performed the randomisation sequence using a Latin Square to ensure a counter-balanced design.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Randomised, double-blind, placebo-controlled
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
11/12/2013
Actual
11/12/2013
Date of last participant enrolment
Anticipated
Actual
3/04/2014
Date of last data collection
Anticipated
Actual
Sample size
Target
34
Accrual to date
Final
36
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 8481 0
3122 - Hawthorn

Funding & Sponsors
Funding source category [1] 289675 0
Commercial sector/Industry
Name [1] 289675 0
Neurobrands LLC
Country [1] 289675 0
United States of America
Primary sponsor type
University
Name
Swinburne University of Technology
Address
Mail H24, PO Box 218
Hawthorn VIC 3122
Country
Australia
Secondary sponsor category [1] 288367 0
None
Name [1] 288367 0
Address [1] 288367 0
Country [1] 288367 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 291411 0
Swinburne University Human Research Ethics Committee (SUHREC)
Ethics committee address [1] 291411 0
Mail H68, PO Box 218
Hawthorn VIC 3122
Ethics committee country [1] 291411 0
Australia
Date submitted for ethics approval [1] 291411 0
Approval date [1] 291411 0
23/07/2014
Ethics approval number [1] 291411 0
SUHREC 2013/073

Summary
Brief summary
This study is a randomised, double-blind, placebo-controlled, crossover trial. A total of 34 healthy right-handed male and female participants aged 18 to 40 years old will take part in the study.

Participants will be required to attend three sessions. The first visit is a screening and practice session, assessing eligibility and familiarising participants with cognitive tasks. Finally, structural brain information will be obtained during an MRI scan. Subsequently, two testing days will be conducted a minimum of 48 hours apart. Participants will be assigned to a treatment sequence, such that one of each treatment is received across the two testing days. At testing days participants will receive a standardised lunch upon arrival, followed by a 30-minute break, then undergo baseline assessment of stress, mood, and cognitive function. After baseline assessment, treatment will be administered. 30-minutes after administration of treatment, participants will once again undergo assessment of stress, mood, and cognitive function, followed by recording of brain activity during rest and an attention task using magnetoencephalography (MEG). After this, the assessment of stress, mood, and cognitive function will be conducted a third time.

Participants will consume all interventions orally as a drink of approximately 430 ml (14.5 fl oz). Both active and vehicle control treatments contain identical ingredients of sweeteners (crystalline fructose and sucralose) and preservatives (sodium benzoate, potassium sorbate) , gum acacia and malic acid. In addition, the active treatment contains L-Theanine (200 mg, L-Tea-Active), L-Alpha Glycerylphosphorylcholine (Alpha GPC; 25 mg)), phosphatidylserine (1mg) and chamomile (10 mg).
Trial website
Trial related presentations / publications
Title: Anti-Stress, Behavioural and Magnetoencephalography Effects of an l-Theanine-Based Nutrient Drink: A Randomised, Double-Blind, Placebo-Controlled, Crossover Trial
Author/Creator: David White; Suzanne de Klerk; William Woods;Shakuntla Gondalia; Chris Noonan; Andrew Scholey
From: Nutrients , 2016, Vol.8(1), p.53
Public notes

Contacts
Principal investigator
Name 50258 0
Prof Andrew Scholey
Address 50258 0
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 50258 0
Australia
Phone 50258 0
+61392148932
Fax 50258 0
Email 50258 0
[email protected]
Contact person for public queries
Name 50259 0
Antionette Goh
Address 50259 0
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 50259 0
Australia
Phone 50259 0
+61392145094
Fax 50259 0
Email 50259 0
[email protected]
Contact person for scientific queries
Name 50260 0
Andrew Scholey
Address 50260 0
Mail H24, PO Box 218,
Swinburne University of Technology,
Hawthorn VIC 3122
Country 50260 0
Australia
Phone 50260 0
+61392148932
Fax 50260 0
Email 50260 0
[email protected]

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What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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