None listed
Conditions
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.
Sponsors
Clinical Research Australia
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
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
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
Outcome results
None listed