NCT04779398

Brief Summary

This study aims to investigate in healthy adults 18-65 years of age the association of electronic device blue light exposure and macular pigment optical density (MPOD) considering usual dietary intake of lutein and zeaxanthin (L/Z) as confirmed by serum lutein and zeaxanthin concentrations. It is hypothesised in healthy adults 18-65 years of age:

  1. 1.Higher usual daily electronic device blue light exposure will be negatively correlated with MPOD value.
  2. 2.Usual dietary intake of L/Z will be positively correlated with MPOD value.
  3. 3.L/Z concentration will be positively correlated with MPOD value.
  4. 4.Usual dietary intake of L/Z will be positively correlated with plasma L/Z concentrations.
  5. 5.Higher usual intake of L/Z will mitigate the effect of higher electronic device exposure on MPOD value.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 25, 2020

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 24, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

March 3, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2022

Completed
Last Updated

May 19, 2022

Status Verified

May 1, 2022

Enrollment Period

1.5 years

First QC Date

January 24, 2021

Last Update Submit

May 17, 2022

Conditions

Keywords

macular pigment optical densityluteinzeaxanthindietary intakeblue light

Outcome Measures

Primary Outcomes (1)

  • Macular Pigment Optical Density

    Machine: Macular Pigment Screener II (Elektron Eye Technology). The non-invasive test uses heterochromatic flicker photometry.

    Triplicate measurement day 1

Secondary Outcomes (3)

  • Dietary intake of lutein and zeaxanthin

    Retrospective intake prior one month

  • Usual use of electronic devices.

    Retrospective use of devices prior 3 months.

  • Blood lutein and zeaxanthin concentration

    Single sample drawn on day of study visit (Day 1).

Other Outcomes (1)

  • Dietary intake of lutein and zeaxanthin on day prior to study visit.

    Intake over single day prior to study visit (Day 1).

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Healthy males and females, 18-65 years of age from Brisbane and surroudning areas, Australia.

You may qualify if:

  • Male and females 18 to 65 years.
  • Generally healthy.
  • No participant reported history of clinically significant medical conditions including, but not limited to, cardiovascular, neurological, psychiatric, renal, immunological, endocrine (including uncontrolled diabetes or thyroid disease) or haematological abnormalities that are uncontrolled.
  • Non-smoker

You may not qualify if:

  • Participant reported diagnosis of serious ocular conditions (e.g. cataracts, glaucoma, diabetic retinopathy, retinitis pigmentosa, Stagardt's disease)
  • Participant reported diagnosis, or current treatment of age-related macular degeneration.
  • Participant reported diagnosis of epilepsy.
  • Current or past smoker (within last 12 months).
  • Under 18 or over 65 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

School of Human Movement and Nutrition Sciences, The University of Queensland

Saint Lucia, Queensland, 4067, Australia

Location

Related Publications (7)

  • Chiu CJ, Chang ML, Zhang FF, Li T, Gensler G, Schleicher M, Taylor A. The relationship of major American dietary patterns to age-related macular degeneration. Am J Ophthalmol. 2014 Jul;158(1):118-127.e1. doi: 10.1016/j.ajo.2014.04.016. Epub 2014 Apr 29.

    PMID: 24792100BACKGROUND
  • Wu J, Seregard S, Algvere PV. Photochemical damage of the retina. Surv Ophthalmol. 2006 Sep-Oct;51(5):461-81. doi: 10.1016/j.survophthal.2006.06.009.

    PMID: 16950247BACKGROUND
  • Algvere PV, Marshall J, Seregard S. Age-related maculopathy and the impact of blue light hazard. Acta Ophthalmol Scand. 2006 Feb;84(1):4-15. doi: 10.1111/j.1600-0420.2005.00627.x.

    PMID: 16445433BACKGROUND
  • Widomska J, Subczynski WK. Why has Nature Chosen Lutein and Zeaxanthin to Protect the Retina? J Clin Exp Ophthalmol. 2014 Feb 21;5(1):326. doi: 10.4172/2155-9570.1000326.

    PMID: 24883226BACKGROUND
  • Stringham JM, Stringham NT, O'Brien KJ. Macular Carotenoid Supplementation Improves Visual Performance, Sleep Quality, and Adverse Physical Symptoms in Those with High Screen Time Exposure. Foods. 2017 Jun 29;6(7):47. doi: 10.3390/foods6070047.

    PMID: 28661438BACKGROUND
  • Williams R, Bakshi S, Ostrin EJ, Ostrin LA. Continuous Objective Assessment of Near Work. Sci Rep. 2019 May 6;9(1):6901. doi: 10.1038/s41598-019-43408-y.

    PMID: 31061427BACKGROUND
  • van der Veen RL, Berendschot TT, Hendrikse F, Carden D, Makridaki M, Murray IJ. A new desktop instrument for measuring macular pigment optical density based on a novel technique for setting flicker thresholds. Ophthalmic Physiol Opt. 2009 Mar;29(2):127-37. doi: 10.1111/j.1475-1313.2008.00618.x.

    PMID: 19236582BACKGROUND

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Plasma blood sample.

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal DegenerationRetinal DiseasesEye Diseases

Study Officials

  • Veronique Chachay, PhD

    The University of Queensland

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2021

First Posted

March 3, 2021

Study Start

September 25, 2020

Primary Completion

March 31, 2022

Study Completion

March 31, 2022

Last Updated

May 19, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations