Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12625000805471p
Ethics application status
Submitted, not yet approved
Date submitted
21/07/2025
Date registered
29/07/2025
Date last updated
29/07/2025
Date data sharing statement initially provided
29/07/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of Magtein on cognitive performance and sleep quality in adults experiencing subjective cognitive difficulties and sleep dissatisfaction
Scientific title
An examination into the effects of Magtein on cognitive performance and sleep quality in adults experiencing subjective cognitive difficulties and sleep dissatisfaction: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 314954 0
None
Universal Trial Number (UTN)
U1111-1325-6298
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive impairment 338272 0
Sleep disturbance 338273 0
Condition category
Condition code
Neurological 334570 334570 0 0
Other neurological disorders
Alternative and Complementary Medicine 334571 334571 0 0
Other alternative and complementary medicine
Mental Health 334572 334572 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 2g a day for 6 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 6.
Intervention code [1] 331555 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] 342247 0
Cognitive Performance
Timepoint [1] 342247 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [1] 450082 0
Cognitive Performance
Timepoint [1] 450082 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [2] 450083 0
Cognitive Performance
Timepoint [2] 450083 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [3] 450084 0
Cognitive Performance
Timepoint [3] 450084 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [4] 450085 0
Sleep quality
Timepoint [4] 450085 0
Day 0 (the day before commencement of intervention), week 2, 4, and 6 post-intervention commencement
Secondary outcome [5] 450086 0
Sleep quality
Timepoint [5] 450086 0
Day 0 (the day before commencement of intervention), week 2, 4, and 6 post-intervention commencement
Secondary outcome [6] 450087 0
Brain Fog
Timepoint [6] 450087 0
Day 0 (the day before commencement of intervention), week 2, 4, and 6 post-intervention commencement
Secondary outcome [7] 450088 0
Global impression of change
Timepoint [7] 450088 0
Week 2 (14 days after the commencement of intervention), 4, and 6 post-intervention commencement
Secondary outcome [8] 450089 0
Cognitive performance
Timepoint [8] 450089 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [9] 450090 0
Cognitive performance
Timepoint [9] 450090 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [10] 450091 0
Cognitive performance
Timepoint [10] 450091 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [11] 450092 0
Cognitive performance
Timepoint [11] 450092 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [12] 450093 0
Cognitive performance
Timepoint [12] 450093 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [13] 450094 0
Cognitive performance
Timepoint [13] 450094 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [14] 450095 0
Cognitive performance
Timepoint [14] 450095 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement
Secondary outcome [15] 450096 0
Brain Fog
Timepoint [15] 450096 0
Day 0 (the day before commencement of intervention), week 2, 4, and 6 post-intervention commencement
Secondary outcome [16] 450097 0
Brain fog
Timepoint [16] 450097 0
Day 0 (the day before commencement of intervention), week 2, 4, and 6 post-intervention commencement
Secondary outcome [17] 450323 0
Cognitive performance
Timepoint [17] 450323 0
Day 0 (the day before commencement of intervention) and week 6 post-intervention commencement

Eligibility
Key inclusion criteria
1. Adults (male and female) aged between 18 to 70 years
2. Subjective complaints with memory and concentration abilities lasting at least 3 months, comprising a rating of 6 or lower on an 11-point scale ranging from 0 (terrible) to 10 (excellent)
3. Subjective complaints of sleep-related problems, lasting at least 4 weeks, comprising a rating of 6 or lower on an 11-point scale ranging from 0 (terrible) to 10 (excellent)
4. Non-smoker
5. BMI between 18 and 30 kg/m2
6. No plan to commence new treatments for cognition or sleep 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
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Suffering from recently diagnosed or unmanaged medical conditions including but not limited to diabetes, hypertension, cardiovascular disease, gallbladder disease, autoimmune disease, renal disease, endocrine disease, or cancer/ malignancy
2. Have a psychiatric disorder (other than mild-to-moderate depression and/or anxiety), or a neurological condition/ disease including but not limited to Parkinson’s or Alzheimer’s disease
3. A score below the 5th percentile for age and educational level on the Modified Telephone Interview for Cognitive Status (TICS-M)
4. Regular medication intake including but not limited to anticonvulsants, benzodiazepines, opioids, corticosteroids, antibiotics 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 influence cognitive function or sleep
7. Work or home conditions that may impact cognition or sleep (e.g., shift worker, caring for an infant, severe stress, recent divorce, the recent passing of a loved one, etc)
8. Current daily use of supplements that contain more than 25mg of elemental magnesium.
9. Alcohol intake greater than 14 standard drinks per week
10. Current or 12-month history of regular illicit drug use
11. Planned major lifestyle change in the next 2 months
12. Pregnant women, women who are breastfeeding, or women who intend to fall pregnant during the study period
13. Any significant surgeries over the last year that continue to affect daily function
14. Participation in any other clinical trial in the last month

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 opaque 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
Not yet recruiting
Date of first participant enrolment
Anticipated
25/08/2025
Actual
Date of last participant enrolment
Anticipated
22/12/2025
Actual
Date of last data collection
Anticipated
2/02/2026
Actual
Sample size
Target
100
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 319512 0
Commercial sector/Industry
Name [1] 319512 0
AIDP Inc.
Country [1] 319512 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 322007 0
Commercial sector/Industry
Name [1] 322007 0
AIDP Inc
Address [1] 322007 0
Country [1] 322007 0
United States of America

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 318087 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 318087 0
Ethics committee country [1] 318087 0
Australia
Date submitted for ethics approval [1] 318087 0
07/07/2025
Approval date [1] 318087 0
Ethics approval number [1] 318087 0

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

Contacts
Principal investigator
Name 143070 0
Dr Adrian Lopresti
Address 143070 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143070 0
Australia
Phone 143070 0
+61 8 94487376
Fax 143070 0
Email 143070 0
[email protected]
Contact person for public queries
Name 143071 0
Adrian Lopresti
Address 143071 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143071 0
Australia
Phone 143071 0
+61 8 94487376
Fax 143071 0
Email 143071 0
[email protected]
Contact person for scientific queries
Name 143072 0
Adrian Lopresti
Address 143072 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 143072 0
Australia
Phone 143072 0
+61 8 94487376
Fax 143072 0
Email 143072 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Case-by-case basis at the discretion of Primary Sponsor

Conditions for requesting access:
• No requirements
What individual participant data might be shared?
• for IPD meta-analyses

What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
A finite period of: 5 years
Where can requests to access individual participant data be made, or data be obtained directly?
• Access subject to approvals by Principal Investigator ([email protected])

Are there extra considerations when requesting access to individual participant data?
No


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.