None listed
Conditions
Brief summary
In this randomised, double-blind, placebo-controlled study, 90 adults aged 40 to 80 years with self-reported memory problems will be randomly assigned to receive tocotrienols (TheraPrimE rice) or a placebo for 12 weeks. Changes in cognitive performance will be assessed at baseline and week 12 by administering the Test of Memory and Learning (TOMAL-2) and Behavior Rating Inventory of Executive Function–Adult Version (BRIEF-A). Moreover, a self-report questionnaire assessing sleep quality will be administered monthly to assess changes in sleep quality. Changes in blood concentrations of several markers associated with inflammation, neuroplasticity, oxidative stress/ antioxidant activity, and blood lipids will also be measured to help identify the mechanisms of action associated with tocotrienol supplementation.
Interventions
Vitamin E (tocotrienols) (1 softgel taken orally, twice daily, with food, delivering 100 mg a day for 12 weeks). Adherence to capsule intake will be measured by a count of capsules returned at week 12.
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
40 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
1. Healthy individuals (male and female) aged between 40 to 80 years 2. Residing in independent living accommodation 3. Subjective report of memory or attention problems by answering ‘yes’ to the following question: Do you have problems with your memory, attention, or concentration? 4. Non-smoker 5. BMI between 18 and 30 kg/m2 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. Diagnosis of dementia based on the revised National Institute on Aging-Alzheimer’s Association (NIA/AA) criteria 2. A score below the 5th percentile for age, education, and gender on the Telephone Interview for Cognitive Status (TICS-M) 3. 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, cancer/ malignancy, acute or chronic pain condition 4. Diagnosis of neurological 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), or cancer/malignancy 5. History of paralysis, stroke or seizures or head injury (with loss of consciousness). 6. Regular medication intake including but not limited to anticholinergics, acetylcholinesterase inhibitors, or steroid medications. 7. Change in medication in the last 3 months or expectation to change during the study duration 8. Taking vitamins or herbal supplements that are reasonably expected to influence study measures. 9. Alcohol intake greater than 14 standard drinks per week 10. Current or 12-month history of illicit drug abuse 11. Pregnant women, women who are breastfeeding, or women who intended to fall pregnant. 12. Any significant surgeries over the last year 13. Planned major lifestyle change in the next 3 months
Outcome results
None listed