Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000427673
Ethics application status
Approved
Date submitted
13/04/2023
Date registered
28/04/2023
Date last updated
19/01/2024
Date data sharing statement initially provided
28/04/2023
Date results information initially provided
19/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
Effects of lutein/ zeaxanthin on eye health, eye strain, sleep quality, and attention in high electronic screen users
Scientific title
Effects of lutein/ zeaxanthin on eye health, eye strain, sleep quality, and attention in high electronic screen users: a randomised, double-blind, placebo-controlled study
Secondary ID [1] 309450 0
None
Universal Trial Number (UTN)
U1111-1291-2557
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Eye health 329701 0
Sleep quality 329702 0
Attention 329703 0
Condition category
Condition code
Eye 326601 326601 0 0
Normal eye development and function
Neurological 326602 326602 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] 325874 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] 334455 0
Visual Fatigue Scale
Timepoint [1] 334455 0
Day 0, 30, 60, 90, 150 and 180 (primary endpoint) post-intervention commencement
Primary outcome [2] 334456 0
Schirmer tear test to examine tear production
Timepoint [2] 334456 0
Day 0, 90, and 180 (primary endpoint) post-intervention commencement
Secondary outcome [1] 420753 0
Computer Vision Syndrome Questionnaire
Timepoint [1] 420753 0
Day 0, 30, 60, 90, 150 and 180 post-intervention commencement
Secondary outcome [2] 420754 0
Photo-stress recovery time assessed using a light from the ophthalmoscope and stopwatch
Timepoint [2] 420754 0
Day 0, 90, and 180 post-intervention commencement
Secondary outcome [3] 420755 0
Contrast sensitivity using the Melbourne Edge Test chart
Timepoint [3] 420755 0
Day 0, 90, and 180 post-intervention commencement
Secondary outcome [4] 420756 0
Visual acuity test using the Snellen chart
Timepoint [4] 420756 0
Day 0, 90, and 180 post-intervention commencement
Secondary outcome [5] 420757 0
Tear film break-up time using sodium fluorescein dye, a slit lamp and stopwatch
Timepoint [5] 420757 0
Day 0, 90, and 180 post-intervention commencement
Secondary outcome [6] 420758 0
PROMIS sleep disturbance and sleep-related impairment scale
Timepoint [6] 420758 0
Day 0, 30, 60, 90, 150 and 180 post-intervention commencement
Secondary outcome [7] 420759 0
Everyday life attention scale
Timepoint [7] 420759 0
Day 0, 90, and 180 post-intervention commencement
Secondary outcome [8] 420760 0
Blood liver function profile (safety measure) comprising aspartate transaminase, alanine aminotransferase, alkaline phosphatase, gamma-glutamyl transferase, total protein, globulin, albumin, and bilirubin.
Timepoint [8] 420760 0
Day 0 and 180 post-intervention commencement
Secondary outcome [9] 420761 0
Renal function blood test (safety measure) comprising urea, creatinine, estimated glomerular filtration rate, sodium, potassium, chloride, and bicarbonate.
Timepoint [9] 420761 0
Day 0 and 180 post-intervention commencement
Secondary outcome [10] 420762 0
Full blood count (safety measure) comprising haemoglobin, red blood cells, haematocrit, mean cell volume, mean cell haemoglobin, mean cell haemoglobin concentration, red blood cell distribution width, white cell count, neutrophils, lymphocytes, monocytes, eosinophils, basophils, platelets, and mean platelet volume
Timepoint [10] 420762 0
Day 0 and 180 post-intervention commencement
Secondary outcome [11] 420763 0
Blood lipid profile (safety measure) comprising cholesterol, triglycerides, high-density lipoprotein, and low-density lipoprotein
Timepoint [11] 420763 0
Day 0 and 180 post-intervention commencement

Eligibility
Key inclusion criteria
1. Generally healthy adults (male and female) 18 to 65 years
2. Spends at least 6 hours a day viewing a screen at a distance of 1 metre or less
3. Non-smoker
4. BMI between 18 and 30 kg/m2
5. No plan to commence new treatments over the study period
6. Willing to maintain current diet, exercise, and supplement regimen during the study period
7. If wearing spectacles for vision, best corrected visual acuity must be 6/6
8. Understand, willing and able to comply with all study procedures
9. Willing to provide a personally signed and dated informed consent form detailing all pertinent aspects of the trial.
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. Ocular disorders including but not limited to cataract, corneal diseases, ocular surface disorders, glaucoma, retinal disease, and myopia (except mild to moderate severity)
2. Undergone eye surgery in the past
3. Wear contact lenses more than 3 days a week
4. Suffering from a recently diagnosed or uncontrolled medical condition including but not limited to: diabetes, hyper/hypotension, cardiovascular disease, gastrointestinal disease, gallbladder disease/gallstones/biliary disease, rheumatoid arthritis or another autoimmune disease, asthma, seasonal allergies, or endocrine disease.
5. 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
6. Regular medication intake including but not limited to steroid medications, hormone replacement therapy, eye drops, antihistamines, beta-blockers, or tricyclic antidepressants.
7. Change in medication in the last 3 months or an expectation to change during the study duration
8. Taking vitamins, herbal, or other nutritional supplements that are reasonably expected to influence study measures.
9. Current or 12-month history of illicit drug abuse
10. Alcohol intake greater than 14 standard drinks per week
11. Women who are pregnant, breastfeeding, or intend to fall pregnant in the next 6 months
12. Any significant surgeries over the last year
13. Planned major lifestyle change in the next 6 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)
Permuted block randomisation using a randomisation table created by computer software
Methods used to generate the sequence in which subjects will be randomised (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
An a priori power analysis was undertaken to estimate the required sample size (based on a single outcome variable). In a study on the effects of lutein and zeaxanthin supplementation on high-screen users, effect sizes on various outcome measures associated with eye health ranged from 0.25 to 1.7. Based on this study, an effect size of 0.7 was predicted. Assuming a power of 80% and a type one error rate (alpha) of 5%, the number of participants required per group to find an effect based on a single outcome measure was estimated as 52. Assuming a 20% dropout rate, it is planned to recruit 35 participants per group (70 participants in total), which is hypothesised to give suitable power to find an effect compared to the placebo, even after dropouts.

Data will be analysed from day 0 to 180 using Generalised Linear Mixed Models (GLMM) with intervention effects assessed by intervention group (placebo and lutein/zeaxanthin) x time interaction.

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
1/05/2023
Actual
17/05/2023
Date of last participant enrolment
Anticipated
15/01/2024
Actual
28/09/2023
Date of last data collection
Anticipated
26/03/2024
Actual
Sample size
Target
70
Accrual to date
Final
70
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 313648 0
Commercial sector/Industry
Name [1] 313648 0
Bio-gen Extracts Pvt. Ltd
Country [1] 313648 0
India
Primary sponsor type
Commercial sector/Industry
Name
Clinical Research Australia
Address
38 Arnisdale Road Duncraig WA 6023
Country
Australia
Secondary sponsor category [1] 315440 0
None
Name [1] 315440 0
Address [1] 315440 0
Country [1] 315440 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312816 0
National Institute of Integrative Medicine (NIIM) Human Research Ethics Committee
Ethics committee address [1] 312816 0
11-23 Burwood Rd Hawthorn VIC 3122
Ethics committee country [1] 312816 0
Australia
Date submitted for ethics approval [1] 312816 0
10/01/2023
Approval date [1] 312816 0
21/02/2023
Ethics approval number [1] 312816 0

Summary
Brief summary
In this randomised, double-blind, placebo-controlled study, 70 high electronic screen users aged 18 to 65 years will be randomly assigned to receive capsules containing either Lute-gen (Lutein 10 mg & Zeaxanthin-isomers 2mg) daily or a placebo for 6 months. Changes in eye strain, eye fatigue, dry eye symptoms and general visual health will be assessed over time by administering several validated self-report questionnaires and objective eye assessments. Moreover, changes in sleep quality and attention will be evaluated over time.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126018 0
Dr Adrian Lopresti
Address 126018 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126018 0
Australia
Phone 126018 0
+61 8 94487376
Fax 126018 0
Email 126018 0
adrian@clinicalresearch.com.au
Contact person for public queries
Name 126019 0
Dr Adrian Lopresti
Address 126019 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126019 0
Australia
Phone 126019 0
+61 8 94487376
Fax 126019 0
Email 126019 0
adrian@clinicalresearch.com.au
Contact person for scientific queries
Name 126020 0
Dr Adrian Lopresti
Address 126020 0
Clinical Research Australia
38 Arnisdale Rd Duncraig WA 6023
Country 126020 0
Australia
Phone 126020 0
+61 8 94487376
Fax 126020 0
Email 126020 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.