An examination into the effects of tocotrienols (TheraPrimE rice) on cognitive abilities in healthy adults

Not Applicable

Recruiting

• Conditions: Cognitive Impairment; Memory impairment; Sleep; Neurological - Other neurological disorders; Alternative and Complementary Medicine - Other alternative and complementary medicine

• Registration Number: ACTRN12624000351516
• Lead Sponsor: Clinical Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-03-27
• Last Update Posted: 29 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 90

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Memory[Test of Memory and Learning (TOMAL-2) Composite Memory Index Day 0 (pre-commencement of intervention) and week 12 (primary endpoint) post-intervention commencement]