Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000351516
Ethics application status
Approved
Date submitted
5/03/2024
Date registered
27/03/2024
Date last updated
21/07/2024
Date data sharing statement initially provided
27/03/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of tocotrienols (TheraPrimE rice) on cognitive abilities in healthy adults
Scientific title
An examination into the effects of tocotrienols (TheraPrimE rice) on cognitive abilities in healthy adults: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 311668 0
None
Universal Trial Number (UTN)
U1111-1305-1188
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Cognitive Impairment 333126 0
Memory impairment 333127 0
Sleep 333128 0
Condition category
Condition code
Neurological 329822 329822 0 0
Other neurological disorders
Alternative and Complementary Medicine 329823 329823 0 0
Other alternative and complementary medicine

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 328132 0
Treatment: Other
Comparator / control treatment
A matching placebo (containing safflower oil) in terms of taste and appearance and containing all ingredients except the active ingredient (tocotrienols/ vitamin E)
Control group
Placebo

Outcomes
Primary outcome [1] 337595 0
Memory
Timepoint [1] 337595 0
Day 0 (pre-commencement of intervention) and week 12 (primary endpoint) post-intervention commencement
Secondary outcome [1] 432433 0
Verbal memory
Timepoint [1] 432433 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [2] 432434 0
Non-verbal memory
Timepoint [2] 432434 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [3] 432435 0
Executive Function
Timepoint [3] 432435 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [4] 432436 0
Change in blood concentrations of tocopherols
Timepoint [4] 432436 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [5] 432437 0
Change in blood concentrations of tocotrienols
Timepoint [5] 432437 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [6] 432438 0
Change in blood concentrations of Tumour Necrosis Factor – alpha
Timepoint [6] 432438 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [7] 432439 0
Change in blood concentrations of interleukin-6
Timepoint [7] 432439 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [8] 432440 0
Change in blood concentrations of high-sensitivity C-reactive protein
Timepoint [8] 432440 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [9] 432441 0
Change in blood concentrations of Malondialdehyde
Timepoint [9] 432441 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [10] 432442 0
Change in blood concentrations of Brain-derived neurotrophic factor
Timepoint [10] 432442 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [11] 432443 0
Change in blood concentrations of Insulin-like growth factor 1 (IGF-1)
Timepoint [11] 432443 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [12] 432444 0
Verbal, delayed memory
Timepoint [12] 432444 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [13] 432445 0
Executive function - Behavioural regulation
Timepoint [13] 432445 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [14] 432446 0
Executive function - Metacognition
Timepoint [14] 432446 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [15] 432447 0
Sleep disturbance
Timepoint [15] 432447 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [16] 432448 0
Sleep-related impairment
Timepoint [16] 432448 0
Day 0 (pre-commencement of intervention), week 4, 8, and 12 post-intervention commencement
Secondary outcome [17] 432449 0
Change in blood concentration of total cholesterol
Timepoint [17] 432449 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [18] 432450 0
Change in blood concentration of low-density lipoprotein (LDL)
Timepoint [18] 432450 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement
Secondary outcome [19] 432451 0
Change in blood concentration of high-density lipoprotein (HDL)
Timepoint [19] 432451 0
Day 0 (pre-commencement of intervention) and week 12 post-intervention commencement

Eligibility
Key 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.
Minimum age
40 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Numbered 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
Recruiting
Date of first participant enrolment
Anticipated
1/05/2024
Actual
4/06/2024
Date of last participant enrolment
Anticipated
16/09/2024
Actual
Date of last data collection
Anticipated
13/12/2024
Actual
Sample size
Target
90
Accrual to date
42
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 315997 0
Commercial sector/Industry
Name [1] 315997 0
BGG Americas, Inc
Country [1] 315997 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 318146 0
None
Name [1] 318146 0
Address [1] 318146 0
Country [1] 318146 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314822 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 314822 0
Ethics committee country [1] 314822 0
Australia
Date submitted for ethics approval [1] 314822 0
22/01/2024
Approval date [1] 314822 0
27/02/2024
Ethics approval number [1] 314822 0
0136E_2024

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

Contacts
Principal investigator
Name 132834 0
Dr Adrian Lopresti
Address 132834 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 132834 0
Australia
Phone 132834 0
+61 8 94487376
Fax 132834 0
Email 132834 0
[email protected]
Contact person for public queries
Name 132835 0
Adrian Lopresti
Address 132835 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 132835 0
Australia
Phone 132835 0
+61 8 94487376
Fax 132835 0
Email 132835 0
[email protected]
Contact person for scientific queries
Name 132836 0
Adrian Lopresti
Address 132836 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 132836 0
Australia
Phone 132836 0
+61 8 94487376
Fax 132836 0
Email 132836 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Individual participant data underlying published results
When will data be available (start and end dates)?
Beginning 3 months and ending 5 years following main results publication
Available to whom?
Case-by-case basis at the discretion of Primary Sponsor
Available for what types of analyses?
for IPD meta-analyses
How or where can data be obtained?
Access subject to approvals by Principal Investigator ([email protected])


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.