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The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep

The dose and timing relationship between theacrine, cognitive performance, and subsequent sleep in healthy adult males

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12623000308695
Enrollment
24
Registered
2023-03-21
Start date
2023-07-19
Completion date
2023-11-15
Last updated
2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This project will investigate the effects of theacrine, a supplement that is similar to caffeine. It is well shown in the literature that caffeine can improve cognitive performance, which refers to the ability of an individual to use their mental processes to perform tasks such as thinking, problem-solving, and decision making. With the similarities to caffeine, it is suggested that theacrine may be able to improve cognitive performance without some of the side effects associated with caffeine including sleep disturbance. However, as theacrine is a relatively new supplement, there is limited investigations to support these findings. Therefore, this project aims to investigate the effect of theacrine dose and timing combinations on cognitive performance across the day and subsequent night-time sleep. Using a placebo-controlled, double-blind, randomised crossover design, participants will complete seven conditions separated by a six-day washout period. Conditions will include a placebo (glucose) and a low (100 mg) and high dose (400 mg) of theacrine administered 12, eight, and four hours prior to bedtime. These timepoints reflect consumption in the morning, afternoon, and evening. With the repeated measures design, it is estimated that 21 participants will be required. Participants will be healthy males aged between 18 and 40 years with no reported medical or sleep condition and a daily habitual caffeine consumption between 2-5mg/kg/day.

Interventions

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 pr

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.

Sponsors

Australian Catholic University
Lead SponsorUniversity

Study design

Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
Male
Age
18 Years to 40 Years
Healthy volunteers
Yes

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

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

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026