Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000308695
Ethics application status
Approved
Date submitted
9/03/2023
Date registered
21/03/2023
Date last updated
21/07/2024
Date data sharing statement initially provided
21/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep
Scientific title
The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep in healthy adult males
Secondary ID [1] 309159 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 329281 0
Cognitive performance 329282 0
Condition category
Condition code
Neurological 326234 326234 0 0
Studies of the normal brain and nervous system
Mental Health 326332 326332 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study is a placebo controlled, double blind, randomised crossover design where each participant will be exposed to seven conditions including a control (placebo) and two different theacrine doses administered over three time points. The intervention will run for seven weeks with a six-day washout between each condition. Conditions include:
- 100 mg of theacrine administered 12 h prior to bedtime
- 100 mg of theacrine administered 8 h prior to bedtime
- 100 mg of theacrine administered 4 h prior to bedtime
- 400 mg of theacrine administered 12 h prior to bedtime
- 400 mg of theacrine administered 8 h prior to bedtime
- 400 mg of theacrine administered 4 h prior to bedtime

Participants will consume a single capsule at all three timepoints (4h ,8h ,12h) each intervention day, however the theacrine dose relevant to the condition will be contained in one capsule, and the remaining two capsules will contain the placebo. Data collection will occur in the home environment of each participant. Participants will be required to send a text message confirmation to confirm compliance with the capsule consumption.

Across each condition day, participants will complete a brief cognitive testing battery on their smartphone and will monitor their subsequent night-time sleep using a portable sleep sensor (Somfit) that will be applied to their forehead using a disposable electrode patch. Participants will control the sleep recording using a smartphone app.
Intervention code [1] 325608 0
Treatment: Other
Comparator / control treatment
For the control condition, all three capsules will contain the placebo. The placebo will be an identical appearing cellulose capsule containing glucose.
Control group
Placebo

Outcomes
Primary outcome [1] 334102 0
Objective sleep outcome:
Total sleep time (min)
Assessed using the Somfit sleep sensor
Timepoint [1] 334102 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Primary outcome [2] 334103 0
Objective sleep outcome:
Sleep efficiency (%)
Assessed using the Somfit sleep sensor
Timepoint [2] 334103 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Primary outcome [3] 334104 0
Objective sleep outcome:
Sleep onset latency (min)
Assessed using the Somfit sleep sensor
Timepoint [3] 334104 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [1] 419354 0
Objective sleep outcome:
Wake after sleep onset (min)
Assessed using the Somfit sleep sensor
Timepoint [1] 419354 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [2] 419355 0
Objective sleep outcome:
Duration of N1 sleep
Assessed using the Somfit sleep sensor
Timepoint [2] 419355 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [3] 419356 0
Objective sleep outcome:
Proportion of N1 sleep relative to total sleep time (%)
Assessed using the Somfit sleep sensor
Timepoint [3] 419356 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [4] 419357 0
Subjective sleep outcome:
Total sleep time (min)
Assessed using a participant-reported electronic sleep diary
Timepoint [4] 419357 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [5] 419358 0
Subjective sleep outcome:
Sleep efficiency (%)
Assessed using a participant-reported electronic sleep diary
Timepoint [5] 419358 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [6] 419359 0
Subjective sleep outcome:
Sleep onset latency (min)
Assessed using a participant-reported electronic sleep diary
Timepoint [6] 419359 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [7] 419360 0
Subjective sleep outcome:
Wake after sleep onset (min)
Assessed using a participant-reported electronic sleep diary
Timepoint [7] 419360 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [8] 419361 0
Subjective sleep outcome:
Sleep quality (1-5 Likert scale)
Assessed using a participant-reported electronic sleep diary
Timepoint [8] 419361 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [9] 419362 0
Karolinska Sleepiness Scale (1-9 Likert scale)
Assessed using a participant-reported electronic questionnaire
Timepoint [9] 419362 0
Immediately prior to bedtime (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [10] 419363 0
Psychomotor Vigilance Task outcome:
Response time (ms) to assess reaction time
Assessed using Inquist6 on smartphone
Timepoint [10] 419363 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [11] 419364 0
Psychomotor Vigilance Task outcome:
Number of lapses (latency >500ms) to assess sustained attention and vigilance
Assessed using Inquist6 on smartphone
Timepoint [11] 419364 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [12] 419365 0
Psychomotor Vigilance Task outcome:
Number of errors (count) to assess sustained attention and vigilance
Assessed using Inquist6 on smartphone
Timepoint [12] 419365 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [13] 419366 0
Simon task outcome:
Proportion (%) of correct responses for all trials, congruent trials (colour/word match), and incongruent trials (colour/word mismatch) to assess cognitive control through response selection and response inhibition
Assessed using Inquist6 on smartphone
Timepoint [13] 419366 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [14] 419367 0
Simon task outcome:
Response time (ms) of correct responses for all trials, congruent trials (colour/word match), and incongruent trials (colour/word mismatch) to assess cognitive control through response selection and response inhibition
Assessed using Inquist6 on smartphone
Timepoint [14] 419367 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [15] 419368 0
Simon task outcome:
Mean difference between response time for congruent and incongruent trials (Simon effect) (ms) to assess cognitive control through response selection and response inhibition
Assessed using Inquist6 on smartphone
Timepoint [15] 419368 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [16] 419369 0
Subjective rating of mood/arousal outcome (VAS):
Level of fatigue (none at all to maximal)
Assessed using a participant-reported electronic questionnaire
Timepoint [16] 419369 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [17] 419370 0
Subjective rating of mood/arousal outcome (VAS):
Level of anxiousness (none at all to maximal)
Assessed using a participant-reported electronic questionnaire
Timepoint [17] 419370 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [18] 419371 0
Subjective rating of mood/arousal outcome (VAS):
Level of alertness (none at all to maximal)
Assessed using a participant-reported electronic questionnaire
Timepoint [18] 419371 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [19] 419372 0
Subjective rating of mood/arousal outcome (VAS):
How positive overall mood is (none at all to maximal)
Assessed using a participant-reported electronic questionnaire
Timepoint [19] 419372 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [20] 419373 0
Subjective rating of mood/arousal outcome (VAS):
Readiness to perform (none at all to maximal)
Assessed using a participant-reported electronic questionnaire
Timepoint [20] 419373 0
15 minutes post waking, 10, six, and two hours prior to bedtime, and 15 minutes post waking the following morning
Secondary outcome [21] 419374 0
Perception of condition using a questionnaire specific to this study:
Perceived dose and timing of theacrine consumed
Assessed using a participant-reported electronic questionnaire
Timepoint [21] 419374 0
Within 30 minutes of waking the following morning
Secondary outcome [22] 419754 0
Objective sleep outcome:
Duration of N2 sleep
Assessed using the Somfit sleep sensor
Timepoint [22] 419754 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [23] 419755 0
Objective sleep outcome:
Duration of N3 sleep
Assessed using the Somfit sleep sensor
Timepoint [23] 419755 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [24] 419756 0
Objective sleep outcome:
Duration of REM sleep
Assessed using the Somfit sleep sensor
Timepoint [24] 419756 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [25] 419757 0
Objective sleep outcome:
Proportion of N2 sleep relative to total sleep time (%)
Assessed using the Somfit sleep sensor
Timepoint [25] 419757 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [26] 419758 0
Objective sleep outcome:
Proportion of N3 sleep relative to total sleep time (%)
Assessed using the Somfit sleep sensor
Timepoint [26] 419758 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)
Secondary outcome [27] 419759 0
Objective sleep outcome:
Proportion of REM sleep relative to total sleep time (%)
Assessed using the Somfit sleep sensor
Timepoint [27] 419759 0
Subsequent overnight sleep bout (12, eight, or four hours from theacrine ingestion depending on the condition)

Eligibility
Key inclusion criteria
-Healthy male aged 18 to 40 years
-Free from any known sleep disorders or disturbances
-Regular caffeine consumer with habitual consumption between 2-5 mg/kg/day
-Non-smoker
-Must be able to provide written informed consent upon having the study procedure explained to them verbally and in writing
Minimum age
18 Years
Maximum age
40 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
-Participant has a clinically diagnosed sleeping disorder
-Participant has a known medical condition or current illness that may affect sleep
-Participant has consumed cigarettes, drugs, or medications known to affect sleep in the three months prior to study admission
-Participant has undertaken overnight shift work in the three months prior to study admission
-Participant has undertaken international time zone travel in the three months prior to study admission

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
19/07/2023
Actual
19/07/2023
Date of last participant enrolment
Anticipated
4/12/2023
Actual
15/11/2023
Date of last data collection
Anticipated
5/02/2024
Actual
5/02/2024
Sample size
Target
21
Accrual to date
Final
24
Recruitment in Australia
Recruitment state(s)
QLD

Funding & Sponsors
Funding source category [1] 313358 0
University
Name [1] 313358 0
Australian Catholic University
Country [1] 313358 0
Australia
Primary sponsor type
University
Name
Australian Catholic University
Address
1100 Nudgee Road
Banyo QLD 4014
Country
Australia
Secondary sponsor category [1] 315109 0
None
Name [1] 315109 0
Address [1] 315109 0
Country [1] 315109 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312580 0
ACU Human Research Ethics Committee
Ethics committee address [1] 312580 0
Ethics committee country [1] 312580 0
Australia
Date submitted for ethics approval [1] 312580 0
09/03/2023
Approval date [1] 312580 0
18/07/2023
Ethics approval number [1] 312580 0

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

Contacts
Principal investigator
Name 125166 0
Prof Shona Halson
Address 125166 0
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 125166 0
Australia
Phone 125166 0
+61 422224491
Fax 125166 0
Email 125166 0
[email protected]
Contact person for public queries
Name 125167 0
Carissa Gardiner
Address 125167 0
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 125167 0
Australia
Phone 125167 0
+61 439833967
Fax 125167 0
Email 125167 0
[email protected]
Contact person for scientific queries
Name 125168 0
Carissa Gardiner
Address 125168 0
Australian Catholic University
1100 Nudgee Road
Banyo QLD 4014
Country 125168 0
Australia
Phone 125168 0
+61 439833967
Fax 125168 0
Email 125168 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


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.