Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000047493
Ethics application status
Approved
Date submitted
20/12/2024
Date registered
20/01/2025
Date last updated
20/01/2025
Date data sharing statement initially provided
20/01/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
An examination into the effects of Lute-gen on Macular Pigment Optical Density (MPOD) and cognitive performance in teenagers
Scientific title
An examination into the effects of Lute-gen on Macular Pigment Optical Density (MPOD) and cognitive performance in teenagers: a randomised, double-blind, placebo-controlled trial
Secondary ID [1] 313600 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eye health 336145 0
Cognitive performance 336146 0
Condition category
Condition code
Eye 332693 332693 0 0
Normal eye development and function
Alternative and Complementary Medicine 332694 332694 0 0
Other alternative and complementary medicine
Neurological 332817 332817 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Lutein and zeaxanthin (Lute-gen) (1 capsule taken orally, once daily with food, delivering 10mg of lutein and 2mg of zeaxanthin for 6 months). Adherence to capsule intake will be measured by capsule return at month 3 and 6.
Intervention code [1] 330197 0
Treatment: Other
Comparator / control treatment
A matching placebo (sunflower oil) in terms of taste and appearance and containing all ingredients except the active ingredient (lutein and zeaxanthin)
Control group
Placebo

Outcomes
Primary outcome [1] 340220 0
Macular pigment
Timepoint [1] 340220 0
Days 0 (day before commencement of intervention), 90, and 180 (primary endpoint) post-intervention commencement
Secondary outcome [1] 443372 0
Visual/ non-verbal memory
Timepoint [1] 443372 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [2] 443373 0
Processing speed
Timepoint [2] 443373 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [3] 443374 0
Attention
Timepoint [3] 443374 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [4] 443375 0
Non-verbal and visual reasoning (this will be assessed as a composite outcome)
Timepoint [4] 443375 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement
Secondary outcome [5] 443376 0
Attention
Timepoint [5] 443376 0
Days 0 (day before commencement of intervention), 90, and day 180 post-intervention commencement
Secondary outcome [6] 443377 0
Sleep
Timepoint [6] 443377 0
Days 0 (day before commencement of intervention), 90, and day 180 post-intervention commencement
Secondary outcome [7] 443378 0
Reaction time and accuracy (this will be assessed as a composite outcome)
Timepoint [7] 443378 0
Days 0 (day before commencement of intervention) and 180 post-intervention commencement

Eligibility
Key inclusion criteria
1. Healthy (male and female) aged between 13 to 18 years (13 years to less than 19 years old)
2. Eats a diet generally low in fruit and vegetables as measured by a score less than or equal to 11 on the Block Rapid Fruit and Vegetable Intake Screener
3. Uses light emitting diode (LED) screens (e.g., televisions, computer screens, mobile/phones, tablets) for more than 4hrs a day
4. If attends school, attends mainstream schooling and mainstream classes
5. BMI equal to or greater than the 5th percentile and less than the 85th percentile for age, sex, and height.
6. Has no plan to commence a new treatment over the study period which might affect the treatment outcomes.
7. The teen and parent/legal guardian of the teen (if under 18 years) are willing to provide personally signed and dated informed consent indicating that they have been informed of all pertinent aspects of the trial.
8. Willing and able to swallow capsules
9. Teen and parent/legal guardian of the teen (if under 18 years) are fluent in English
Minimum age
13 Years
Maximum age
18 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Has a diagnosed learning disability
2. Has a current or 12-month history of any significant psychiatric disorder (including attention deficit hyperactivity disorder)
3. Has a current or history of clinically significant chronic medical condition including cardiovascular disease, organic brain disorder, seizure, diabetes, or gastrointestinal disease
4. Is currently taking pharmaceutical medications that might affect the treatment outcomes.
5. Is regularly taking nutritional or herbal supplements that might affect the treatment outcomes.
6. Is experiencing exceptional social/family stressors (e.g., serious illness in the family, recent parental separation, etc).
7. Has plans for major lifestyle changes in the next 6 months.
8. Is a regular nicotine smoker or vaper
9. Currently (or in the last 12 months) has used illicit drugs
10. Consumes more than 14 standard drinks of alcohol a week
11. Is pregnant, breastfeeding, or intends to fall pregnant during the study period.
12. Has had a major surgery over the last year or has a planned major surgery during the study period
13. Has participated in any other clinical trial in the last month

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)
Opaque 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
Not yet recruiting
Date of first participant enrolment
Anticipated
31/01/2025
Actual
Date of last participant enrolment
Anticipated
23/06/2025
Actual
Date of last data collection
Anticipated
22/12/2025
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 318071 0
Commercial sector/Industry
Name [1] 318071 0
Bio-gen Extracts Pvt. Ltd
Country [1] 318071 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
Country
Australia
Secondary sponsor category [1] 320426 0
None
Name [1] 320426 0
Address [1] 320426 0
Country [1] 320426 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316720 0
National Institute of Integrative Medicine Human Research Ethics Committee
Ethics committee address [1] 316720 0
Ethics committee country [1] 316720 0
Australia
Date submitted for ethics approval [1] 316720 0
01/07/2024
Approval date [1] 316720 0
17/08/2024
Ethics approval number [1] 316720 0
0145E_2024

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

Contacts
Principal investigator
Name 138782 0
Dr Adrian Lopresti
Address 138782 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138782 0
Australia
Phone 138782 0
+61 08 94487376
Fax 138782 0
Email 138782 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 138783 0
Adrian Lopresti
Address 138783 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138783 0
Australia
Phone 138783 0
+61 08 94487376
Fax 138783 0
Email 138783 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 138784 0
Adrian Lopresti
Address 138784 0
Clinical Research Australia, 38 Arnisdale Road Duncraig WA 6023
Country 138784 0
Australia
Phone 138784 0
+61 08 94487376
Fax 138784 0
Email 138784 0
adrian@clinicalresearch.com.au

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 (adrian@clinicalresearch.com.au)


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.