Trial Review

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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
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
Secondary ID [1] 311761 0
None
Universal Trial Number (UTN)
U1111-1305-7183
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 333264 0
Sleep disturbance 333265 0
Condition category
Condition code
Neurological 329957 329957 0 0
Other neurological disorders
Alternative and Complementary Medicine 329958 329958 0 0
Other alternative and complementary medicine
Mental Health 329959 329959 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 328216 0
Treatment: Other
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)
Control group
Placebo

Outcomes
Primary outcome [1] 337717 0
Cognitive Peformance
Timepoint [1] 337717 0
Day -7 (7 days before commencement of intervention) and week 6 (primary endpoint) post-intervention commencement
Secondary outcome [1] 432945 0
Cognitive Peformance
Timepoint [1] 432945 0
Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [2] 432946 0
Cognitive Peformance
Timepoint [2] 432946 0
Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [3] 432947 0
Cognitive Peformance
Timepoint [3] 432947 0
Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [4] 432948 0
Sleep quality
Timepoint [4] 432948 0
Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
Secondary outcome [5] 432949 0
Sleep quality
Timepoint [5] 432949 0
Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
Secondary outcome [6] 432950 0
Restorative sleep
Timepoint [6] 432950 0
Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
Secondary outcome [7] 432951 0
Sleep quality
Timepoint [7] 432951 0
Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
Secondary outcome [8] 432952 0
Sleep quality
Timepoint [8] 432952 0
Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
Secondary outcome [9] 432953 0
Sleep quality
Timepoint [9] 432953 0
Daily day -7 (7 days before commencement of intervention) to week 6 post-intervention commencement
Secondary outcome [10] 432954 0
World Health Organisation (WHO) - 5 Wellbeing Index (WHO-5)
Timepoint [10] 432954 0
Day -7 (7 days before commencement of intervention), day 0, week 2, 4, and 6 post-intervention commencement
Secondary outcome [11] 432955 0
Reaction time and accuracy
Timepoint [11] 432955 0
Day -7 (7 days before commencement of intervention) and week 6 post-intervention commencement

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
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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

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)
Numbered containers
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)
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

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
30/04/2024
Actual
26/04/2024
Date of last participant enrolment
Anticipated
30/09/2024
Actual
Date of last data collection
Anticipated
15/11/2024
Actual
Sample size
Target
100
Accrual to date
59
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 316096 0
Commercial sector/Industry
Name [1] 316096 0
AIDP Inc.
Country [1] 316096 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 318263 0
None
Name [1] 318263 0
Address [1] 318263 0
Country [1] 318263 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314919 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 314919 0
Ethics committee country [1] 314919 0
Australia
Date submitted for ethics approval [1] 314919 0
05/03/2024
Approval date [1] 314919 0
16/04/2024
Ethics approval number [1] 314919 0
0140E_2024

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

Contacts
Principal investigator
Name 133142 0
Dr Adrian Lopresti
Address 133142 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 133142 0
Australia
Phone 133142 0
+61 8 94487376
Fax 133142 0
Email 133142 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 133143 0
Adrian Lopresti
Address 133143 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 133143 0
Australia
Phone 133143 0
+61 8 94487376
Fax 133143 0
Email 133143 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 133144 0
Adrian Lopresti
Address 133144 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 133144 0
Australia
Phone 133144 0
+61 8 94487376
Fax 133144 0
Email 133144 0
adrian@clinicalresearch.com.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator (adrian@clinicalresearch.com.au)


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.