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Trial registered on ANZCTR
Registration number
ACTRN12624000379516
Ethics application status
Approved
Date submitted
18/03/2024
Date registered
2/04/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
2/04/2024
Type of registration
Prospectively registered
Titles & IDs
Public title
An examination into the effects of Magtein on cognitive performance and sleep quality in young adults experiencing dissatisfied sleep
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Scientific title
An examination into the effects of Magtein on cognitive performance and sleep quality in young adults experiencing dissatisfied sleep: a randomised, double-blind, placebo-controlled trial
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Secondary ID [1]
311761
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None
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Universal Trial Number (UTN)
U1111-1305-7183
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment
333264
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Sleep disturbance
333265
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Condition category
Condition code
Neurological
329957
329957
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0
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Other neurological disorders
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Alternative and Complementary Medicine
329958
329958
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0
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Other alternative and complementary medicine
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Mental Health
329959
329959
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0
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Other mental health disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Magnesium L-threonate (Magtein) (1 capsule taken orally, twice daily, with or without food, delivering 1800 mg a day for 6 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 6.
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Intervention code [1]
328216
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Treatment: Other
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Comparator / control treatment
A matching placebo (containing rice flour) in terms of taste and appearance and containing all ingredients except the active ingredient (magnesium L-threonate)
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Control group
Placebo
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Outcomes
Primary outcome [1]
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Cognitive Peformance
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Assessment method [1]
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National Institute of Health (NIH) Toolbox Cognition Battery: total cognition composite score
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Timepoint [1]
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Day -7 (7 days before commencement of intervention) and week 6 (primary endpoint) post-intervention commencement
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Secondary outcome [1]
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Cognitive Peformance
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Assessment method [1]
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National Institute of Health (NIH) Toolbox Cognition Battery: fluid composite score
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Timepoint [1]
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Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
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Secondary outcome [2]
432946
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Cognitive Peformance
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Assessment method [2]
432946
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National Institute of Health (NIH) Toolbox Cognition Battery: crystalized composite score
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Timepoint [2]
432946
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Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
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Secondary outcome [3]
432947
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Cognitive Peformance
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Assessment method [3]
432947
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Raven’s 2 Total Raw Score
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Timepoint [3]
432947
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Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
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Secondary outcome [4]
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Sleep quality
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Assessment method [4]
432948
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PROMIS Sleep disturbance score
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Timepoint [4]
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Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
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Secondary outcome [5]
432949
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Sleep quality
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Assessment method [5]
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PROMIS Sleep-related impairment score
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Timepoint [5]
432949
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Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
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Secondary outcome [6]
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Restorative sleep
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Assessment method [6]
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Restorative Sleep Questionnaire total score
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Timepoint [6]
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Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
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Secondary outcome [7]
432951
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Sleep quality
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Assessment method [7]
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Oura Ring: total sleep time (min)
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Timepoint [7]
432951
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Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
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Secondary outcome [8]
432952
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Sleep quality
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Assessment method [8]
432952
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Our Ring: sleep efficiency (perecent)
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Timepoint [8]
432952
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Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
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Secondary outcome [9]
432953
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Sleep quality
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Assessment method [9]
432953
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Oura Ring: sleep latency (minutes)
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Timepoint [9]
432953
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Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
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Secondary outcome [10]
432954
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World Health Organisation (WHO) - 5 Wellbeing Index (WHO-5)
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Assessment method [10]
432954
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WHO-5 total score
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Timepoint [10]
432954
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Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
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Secondary outcome [11]
432955
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Reaction time and accuracy
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Assessment method [11]
432955
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3D Aim Trainer total score
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Timepoint [11]
432955
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Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
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Eligibility
Key inclusion criteria
1. Adults (male and female) aged between 18 to 45 years.
2. Self-reported symptoms of poor sleep lasting longer than 4 weeks.
3. Non-smoker
4. BMI between 18 and 35 kg/m2
5. Typical bedtime is between 9 p.m. and 12 a.m.
6. No plan to commence new treatments over the study period
7. Understand, willing and able to comply with all study procedures
8. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial
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Minimum age
18
Years
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Maximum age
45
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
1. Suffer from a diagnosed sleep disorder other than moderate insomnia (e.g., sleep apnoea, restless leg syndrome, periodic limb movement disorder)
2. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease requiring regular use of medications, gallbladder disease/gallstones/biliary disease, autoimmune disease, endocrine disease, acute or chronic pain condition
3. Diagnosis of medical or psychiatric conditions including but not limited to: psychiatric disorder (other than mild-to-moderate depression or anxiety), neurological disease (Parkinson’s, Alzheimer’s disease, intracranial haemorrhage, head or brain injury), pr cancer/malignancy
4. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, or immunosuppressants.
5. Change in medication in the last 3 months or an expectation to change during the study duration.
6. In the last 3 months, commenced or changed the dose of nutritional and/or herbal supplements that may impact treatment outcomes.
7. Current use of supplements that contain more than 25mg of elemental magnesium.
8. Coffee intake greater than 3 cups a day (or equivalent caffeine intake from other caffeinated drinks e.g., tea, energy drinks)
9. Experiencing external or lifestyle factors that may affect sleep patterns (e.g., infant/children regularly wakening, excess noise, a snoring partner, pain condition, variable work or study schedules, mid-to-late afternoon/ evening intake of caffeine)
10. Currently experiencing a severe life stressor (e.g., work, finances, relationship, health) that significantly impacts on daily function and activity
11. Planned major lifestyle change in the next 3 months.
12. Alcohol intake greater than 14 standard drinks per week
13. Illicit drug use in the last 12 months
14. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period.
15. Any significant surgeries over the last year or planned surgery during the study period
16. Participation in any other clinical trial in the last 3 months
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered containers
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. computerised sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
30/04/2024
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Actual
26/04/2024
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Date of last participant enrolment
Anticipated
30/09/2024
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Actual
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Date of last data collection
Anticipated
15/11/2024
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Actual
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Sample size
Target
100
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Accrual to date
59
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Final
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Recruitment in Australia
Recruitment state(s)
WA
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Funding & Sponsors
Funding source category [1]
316096
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Commercial sector/Industry
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Name [1]
316096
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AIDP Inc.
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Address [1]
316096
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Country [1]
316096
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United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Clinical Research Australia
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Address
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Country
Australia
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Secondary sponsor category [1]
318263
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None
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Name [1]
318263
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Address [1]
318263
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Country [1]
318263
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
314919
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National Institute of Integrative Medicine Human Research Ethics Committee
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Ethics committee address [1]
314919
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https://niim.com.au/research/niim-human-research-ethics-committee
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Ethics committee country [1]
314919
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Australia
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Date submitted for ethics approval [1]
314919
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05/03/2024
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Approval date [1]
314919
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16/04/2024
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Ethics approval number [1]
314919
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0140E_2024
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Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 young-to-middle-aged adults aged 18 to 45 years with self-reported sleep difficulties will be randomly assigned to receive magnesium L-threonate (Magtein) or a placebo for 6 weeks. Changes in cognitive performance will be assessed at baseline and week 6 by administering The National Institutes of Health (NIH) Toolbox Cognition Battery and Raven’s Progressive Matrices Second Edition (Raven’s 2). Moreover, self-report questionnaires will be administered to examine changes in sleep quality, restorative sleep, and general wellbeing. Changes in sleep patterns will also be monitored using an Oura Ring. Finally, to measure potential changes in gaming skills, the 3D Aim Trainer, a first-person shooting game, will be administered at baseline and week 6.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
133142
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Dr Adrian Lopresti
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Address
133142
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
133142
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Australia
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Phone
133142
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+61 8 94487376
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Fax
133142
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Email
133142
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[email protected]
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Contact person for public queries
Name
133143
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Adrian Lopresti
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Address
133143
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
133143
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Australia
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Phone
133143
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+61 8 94487376
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Fax
133143
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Email
133143
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[email protected]
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Contact person for scientific queries
Name
133144
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Adrian Lopresti
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Address
133144
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Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
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Country
133144
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Australia
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Phone
133144
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+61 8 94487376
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Fax
133144
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Email
133144
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
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What data in particular will be shared?
Individual participant data underlying published results
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When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
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Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
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Available for what types of analyses?
for IPD meta-analyses
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How or where can data be obtained?
Access subject to approvals by Principal Investigator (
[email protected]
)
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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.
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