Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12621000038897
Ethics application status
Approved
Date submitted
14/12/2020
Date registered
18/01/2021
Date last updated
28/03/2022
Date data sharing statement initially provided
18/01/2021
Date results provided
28/03/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of Lutein/Zeaxanthin supplementation on cognitive function in adults with self-reported mild cognitive complaints
Scientific title
The effects of Lutein/Zeaxanthin supplementation on cognitive function in adults with self-reported mild cognitive complaints: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 303014 0
None
Universal Trial Number (UTN)
U1111-1262-6756
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Mild cognitive impairment 320079 0
Condition category
Condition code
Neurological 318008 318008 0 0
Other neurological disorders
Alternative and Complementary Medicine 318009 318009 0 0
Other alternative and complementary medicine
Mental Health 318235 318235 0 0
Other mental health disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Condition 1: Placebo capsules (1 capsule taken orally, once daily with dinner for 180 days)

Condition 2: Lutein and Zeaxanthin (1 capsule taken orally, once daily with dinner, delivering 10mg Lutein and 2mg Zeaxanthin a day, for 180 days)

Adherence to capsule intake will be monitored through a mobile phone app and capsule return and count.
Intervention code [1] 319301 0
Treatment: Drugs
Comparator / control treatment
Placebo (containing sunflower oil) is matched to the Lutein/Zeaxanthin capsules in terms of taste and appearance but does not contain any of the active ingredients.
Control group
Placebo

Outcomes
Primary outcome [1] 326004 0
Change in cognitive performance as measured by the Computerised Mental Performance Assessment System (COMPASS)
Timepoint [1] 326004 0
Day 0 and 180
Secondary outcome [1] 389833 0
Change in cognitive skills as measured by the Cognitive Failures Questionnaire (CFQ)
Timepoint [1] 389833 0
Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention
Secondary outcome [2] 389834 0
Change in Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)
Timepoint [2] 389834 0
Day 0 (pre-intervention), 60, 120 and 180 post-intervention
Secondary outcome [3] 389835 0
Change in Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29):
Timepoint [3] 389835 0
Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention
Secondary outcome [4] 389836 0
Change in Profile of Mood States, abbreviated version (POMS):
Timepoint [4] 389836 0
Day 0 (pre-intervention), 30, 60, 90, 120, 150, and 180 post-intervention

Eligibility
Key inclusion criteria
1. Healthy adults (male and female) between 40 and 75 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 35 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
75 Years
Sex
Both males and females
Can healthy volunteers participate?
No
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, acute or chronic pain condition
4. 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), or cancer/malignancy
5. History of 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. Current nutrient deficiencies including low iron or vitamin B12 concentrations
9. Taking vitamins or herbal supplements that are reasonably expected to influence study measures.
10. Current or 12-month history of illicit drug abuse
11. Alcohol intake greater than 14 standard drinks per week
12. Any significant surgeries over the last year

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)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation using a randomisation table created by a computer software. This computer-generated randomisation structure will comprise 10 randomly permuted blocks, containing 10 participants per block.
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
Based on previous studies on herbal treatments for mild cognitive impairment, we are predicting an effect size of 0.6 compared to placebo. Based on this, a sample size of 72 is required. This gives an 80% chance of finding an effect at a statistical significance of 0.05. In this study, we will be recruiting 45 participants per group (90 participants in total), which should give us a suitable power to find an effect, even after dropouts.

Pre and post analyses will be conducted to determine changes in the following:

1. Computerised Mental Performance Assessment System (COMPASS)
2. Profile of Mood States, abbreviated version (POMS)
3. Patient-Reported Outcomes Measurement Information System - 29 (PROMIS-29)
4. Cognitive Failures Questionnaire (CFQ)
5. Behavior Rating Inventory of Executive Function – Adult Version (BRIEF-A)

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
29/01/2021
Actual
5/02/2021
Date of last participant enrolment
Anticipated
30/06/2021
Actual
23/04/2021
Date of last data collection
Anticipated
22/10/2021
Actual
27/10/2021
Sample size
Target
90
Accrual to date
Final
96
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 307425 0
Commercial sector/Industry
Name [1] 307425 0
Bio-gen Extracts Private Limited
Country [1] 307425 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Rd Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 308094 0
None
Name [1] 308094 0
Address [1] 308094 0
Country [1] 308094 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 307507 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 307507 0
Ethics committee country [1] 307507 0
Australia
Date submitted for ethics approval [1] 307507 0
10/11/2020
Approval date [1] 307507 0
22/12/2020
Ethics approval number [1] 307507 0
0082E_2020

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

Contacts
Principal investigator
Name 107482 0
Dr Adrian Lopresti
Address 107482 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 107482 0
Australia
Phone 107482 0
+61894487376
Fax 107482 0
Email 107482 0
[email protected]
Contact person for public queries
Name 107483 0
Adrian Lopresti
Address 107483 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 107483 0
Australia
Phone 107483 0
+61894487376
Fax 107483 0
Email 107483 0
[email protected]
Contact person for scientific queries
Name 107484 0
Adrian Lopresti
Address 107484 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 107484 0
Australia
Phone 107484 0
+61894487376
Fax 107484 0
Email 107484 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.