None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 100 adults aged 18 to 70 years with self-reported cognitive and sleep-related 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 NIH Toolbox Cognition Battery and related subtests. Moreover, self-report questionnaires will be administered to examine changes in sleep quality and brain fog.
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 70 Years
Healthy volunteers
No
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.
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
Outcome results
None listed