Effects of dietary supplementation containing lutein, zeaxanthin, and omega-3 polyunsaturated fatty on the serum carotenoids and fatty acids concentrations, macular pigment and visual function in people with long-term computer display light exposure

Phase 4

Active, not recruiting

• Conditions: Serum carotenoids and fatty acids concentrations, macular pigment and visual function in people with long-term computer display light exposure; lutein, zeaxanthin, omega-3 polyunsaturated fatty, macular pigment, visual function, light exposure

• Registration Number: TCTR20220904002
• Lead Sponsor: BYHEALTH Institute of Nutrition & Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-09-04
• Study Completion: 2022-12-31
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Active, not recruiting
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1) Individuals aged between18 and 45 years who has a screen time of more than 8 h/day within two years
2) were able and willing to consent to both the qualification and the randomization/follow-up phases of the study
3) were likely, willing and able to undergo examinations for at least three times
4) agreed to stop current use of supplements containing lutein, zeaxanthin, omega-3 LCPUFAs (specifically DHA and EPA), beta-carotene, other than those supplied by our study

Exclusion Criteria

1) A chronic requirement for any systemic or ocular medication administered for other diseases and known to be toxic to the retina or optic nerve
2) Previous daily supplementation with lutein and/or omega-3 LCPUFAs within six months
3) History of ocular trauma or eye surgery
4) A chronic requirement for any systemic or ocular medication administered for other diseases and known to be toxic to the retina or optic nerve
5) Any condition that would make adherence or follow-up difficult or unlikely

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Serum carotenoids and fatty acids concentrations At baseline, 12 weeks, and 24 weeks during the intervention High performance liquid chromatography,Macular pigment optical density At baseline, 12 weeks, and 24 weeks during the intervention MPS II,Uncorrected visual acuity At baseline, 12 weeks, and 24 weeks during the intervention ETDRS chart,Corrected visual acuity At baseline, 12 weeks, and 24 weeks during the intervention ETDRS chart,Contrast sensitivity At baseline, 12 weeks, and 24 weeks during the intervention CSV-1000,Glare sensitivity At baseline, 12 weeks, and 24 weeks during the intervention CSV-1000

Secondary Outcome Measures

Name	Time	Method
Dietary carotenoid and omega-3 intake At baseline, 12 weeks, and 24 weeks during the intervention Food frequency questionnaire,Dry eye assessment At baseline, 12 weeks, and 24 weeks during the intervention The Ocular Surface Disease Index and OCULUS Keratograph,Macular thickness At baseline, 12 weeks, and 24 weeks during the intervention Optical coherence tomography,Visual quality At baseline, 12 weeks, and 24 weeks during the intervention Optical quality analysis system and OPD Scan ,Key gene related to the effect of the intervention At baseline Genome-wide association studies