Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000776606
Ethics application status
Approved
Date submitted
4/07/2023
Date registered
17/07/2023
Date last updated
25/08/2024
Date data sharing statement initially provided
17/07/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of green tea amino acid L-Theanine formulation on markers of stress and quality of sleep (THESLeep Project)
Scientific title
The effect of green tea amino acid L-Theanine formulation on markers of stress and quality of sleep in adults with mild to moderate sleep disturbances (THESLeep Project).
Secondary ID [1] 309582 0
Nil known
Universal Trial Number (UTN)
U1111-1292-0328
Trial acronym
THESleep project
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Quality of sleep 329885 0
Anxiety 329887 0
Condition category
Condition code
Mental Health 326789 326789 0 0
Anxiety
Alternative and Complementary Medicine 326790 326790 0 0
Other alternative and complementary medicine
Neurological 327485 327485 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All enrolled participants will be allocated into one of the three treatment groups or into the control group. After one week baseline measurements, participants in the treatment groups will be provided with the L-theanine sachet for period of two weeks containing, flavoring and effervescent powder and 100, 200 or 400mg of L-theanine. Participants will be asked to consume the content of the sachet by dissolving it in the water (around 125 ml) one hour before bedtime every evening for 14 days.

Participants will be asked to return their supplement at the end of the treatment period. Unused sachets will be counted to determine the compliance.
Intervention code [1] 326416 0
Treatment: Other
Comparator / control treatment
Comparator (placebo) consists of sachet containing the same flavouring ingredients as the intervention sachet without the addition of L-theanine. Participants will be instructed to consume the placebo sachet in a same manner as in treatment groups.

Participants will be asked to return their unused sachets at the end of the treatment period. Unused sachets will be counted to determine the compliance.
Control group
Placebo

Outcomes
Primary outcome [1] 335234 0
Sleep onset latency (Measured using Motionwatch 8 Actigraphy device)
Timepoint [1] 335234 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Primary outcome [2] 335283 0
Pittsburgh Sleep Quality Index (PSQI)
Timepoint [2] 335283 0
Administered at screening, baseline (Week 1 post-screening), start of the treatment (Week 2 post-screening), end of the treatment (Week 3 post-screening) and two week post completion follow up.
Primary outcome [3] 335284 0
The Consensus Sleep Diary (15 item)
Timepoint [3] 335284 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Secondary outcome [1] 423722 0
Salivary marker of stress (diurnal cortisol)
Timepoint [1] 423722 0
End of baseline week (Week 1 post-screening) and End of treatment period (Week 3 post-screening)
Secondary outcome [2] 423723 0
Heart Rate Variability (using Polar H10, HR Sensor chest strap)
Timepoint [2] 423723 0
End of baseline week (Week 1 post-screening) and End of treatment period (Week 3 post-screening
Secondary outcome [3] 423724 0
Resting Blood Pressure using digital blood pressure monitor (Omron, Florida, USA)
Timepoint [3] 423724 0
End of baseline week (Week 1 post-screening) and End of treatment period (Week 3 post-screening)
Secondary outcome [4] 423734 0
Depression Anxiety and Stress Scale 21 (DASS-21) - this will be assessed as a composite outcome
Timepoint [4] 423734 0
End of baseline week (Week 1 post-screening) and End of treatment period (Week 3 post-screening)
Secondary outcome [5] 424097 0
Percent sleep efficiency (Measured using Motionwatch 8 Actigraphy device) - This is an additional primary outcome
Timepoint [5] 424097 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Secondary outcome [6] 424098 0
Sleep duration (Measured using Motionwatch 8 Actigraphy device) - This is an additional primary outcome
Timepoint [6] 424098 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Secondary outcome [7] 424100 0
Total sleep time (Measured using Motionwatch 8 Actigraphy device) - This is an additional primary outcome
Timepoint [7] 424100 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Secondary outcome [8] 424101 0
Wake after sleep onset (Measured using Motionwatch 8 Actigraphy device) - This is an additional primary outcome
Timepoint [8] 424101 0
Administered every night during the baseline period (Week 1 post-screening) and during the treatment period (Week 2 and 3 post-screening)
Secondary outcome [9] 424102 0
Salivary marker of stress (alpha-amylase)
Timepoint [9] 424102 0
End of baseline week (Week 1 post-screening) and End of treatment period (Week 3 post-screening)

Eligibility
Key inclusion criteria
Healthy participants with mild to moderate sleep disturbances that score greater or equal to 5 on the Pittsburgh Sleep Quality Index (PSQI) questionnaire.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Smokers, known cardiovascular, hepatic, gastrointestinal, renal, malignant, neurological, degenerative illnesses, suffer from diabetes (type 1 and type 2), are pregnant or lactating. Suffer from clinical sleep disorders (obstructive sleep apnoea), are shift workers or have completed trans-meridian travel within the previous month. Taking medication or herbal supplements for sleep, or taking antipsychotic or hypnotic medication. Adults older than 65 years as well as children and adolescents are also excluded.

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 will be assigned a pre-determined and unique four digit participant code during enrollment which will be non-identifiable. All participants will be randomly allocated either the placebo group or one of three treatment groups.
Method of allocation will be located within a sealed envelope and broken when they study is completed (all participants data) is final.
The person randomising the participants will not know the treatment allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Sequence generation will be block randomised 1:1:1:1 using an online randomizer tool (https://www.randomizer.org/).
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
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The total number of participants required for this study will be 60 (15 per group). This number was calculated with percent sleep efficiency as the primary outcome measure, based on results from a previous studies. With power set to 0.8 and a type 1 error rate a = 0.05, the sample size for a pilot study to explore a 30-40% effectiveness is 10-15 participants per arm as per estimating the sample size for a pilot randomised trial to minimise the overall trial sample size for the external pilot and main trial for a continuous outcome variable. The sample size also accounts for modest participant dropout (20%) and incomplete sleep data. All data will be exported into SPSS (v27 or later) and statistical analysis will comprise baseline to post-intervention within-group and between-group effects using paired Student's t-test and repeated measures ANOVA for within-between group analysis with Bonferroni post-hoc correction.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/07/2023
Actual
7/08/2023
Date of last participant enrolment
Anticipated
31/05/2024
Actual
12/07/2024
Date of last data collection
Anticipated
31/05/2024
Actual
2/08/2024
Sample size
Target
60
Accrual to date
Final
49
Recruitment in Australia
Recruitment state(s)
ACT,NSW
Recruitment postcode(s) [1] 40724 0
2617 - University Of Canberra
Recruitment postcode(s) [2] 40725 0
2600 - Canberra
Recruitment postcode(s) [3] 40726 0
2620 - Queanbeyan

Funding & Sponsors
Funding source category [1] 313768 0
University
Name [1] 313768 0
University of Canberra (Discovery Translation Fund 5.0)
Country [1] 313768 0
Australia
Primary sponsor type
University
Name
University of Canberra
Address
11 Kirinari Street
Bruce ACT 2617
Country
Australia
Secondary sponsor category [1] 315597 0
Individual
Name [1] 315597 0
Professor Nenad Naumovski
Address [1] 315597 0
University of Canberra
PO Box 5018
Bruce, ACT, 2617
Country [1] 315597 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312936 0
University of Canberra Human Research Ethics Committee
Ethics committee address [1] 312936 0
Ethics committee country [1] 312936 0
Australia
Date submitted for ethics approval [1] 312936 0
31/05/2023
Approval date [1] 312936 0
28/06/2023
Ethics approval number [1] 312936 0
2023-13247

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126402 0
Prof Nenad Naumovski
Address 126402 0
University of Canberra
PO Box 5018
Bruce, ACT, 2617
Country 126402 0
Australia
Phone 126402 0
+61 2 62068719
Fax 126402 0
Email 126402 0
[email protected]
Contact person for public queries
Name 126403 0
Nenad Naumovski
Address 126403 0
University of Canberra
PO Box 5018
Bruce, ACT, 2617
Country 126403 0
Australia
Phone 126403 0
+61 2 62068719
Fax 126403 0
Email 126403 0
[email protected]
Contact person for scientific queries
Name 126404 0
Nenad Naumovski
Address 126404 0
University of Canberra
PO Box 5018
Bruce, ACT, 2617
Country 126404 0
Australia
Phone 126404 0
+61 2 62068719
Fax 126404 0
Email 126404 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Participants have not consented to provide IPD


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19610Clinical study report    A clinical study report will be provided when the ... [More Details]



Results publications and other study-related documents

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