NCT07355725

To Evaluate the Efficacy of Lutemax 2020 on Vision and Cognitive Performance in Health Children.

A Prospective, Randomized, Double-Blind, Parallel, Placebo- Controlled Study to Evaluate Efficacy of Lutemax 2020 (Lutein 10 mg & Zeaxanthin Isomers 2 mg) on Vision and Cognitive Performance in Children

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Bioagile Therapeutics Pvt. Ltd. · Industry
• Sex: All
• Age: 5 Years – 12 Years
• Healthy volunteers: Accepted

Summary

To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children

Detailed description

Extensive exposure to digital devices like laptops, smart phones, etc.is a result of advanced technology in today's modern world. Especially, the children of 21st century are avid users of technology. The precipitous rise in the use of digital devices has raised concerns about potentially deleterious health effects due to increased screen time and associated exposure to short wavelength blue light. Adverse effects include damage to retina, physical health and cognitive performance. To adapt to this change, a diet-derived, blue-absorbing pigment, composed of the dietary carotenoids lutein (L) and zeaxanthin (Z), which are found in relatively high concentrations in leafy-green vegetables, and along with the Z isomer mesozeaxanthin (MZ), are deposited in rich concentrations in the macular retina. They play an important role in protecting the retina from cumulative damage that can result in visual and cognitive detriments and further progress to Age-related Macular Degeneration (AMD). To address the detrimental effects of the sudden rise in the use of digital devices leading to increased screen time, the present study will assess the efficacy of macular carotenoid supplementation Lutemax 2020 in young children. Efficacy will be evaluated based on the effect of Lutemax 2020 on MPOD and other visual parameters, visual processing speed, contrast sensitivity along with cognitive performance parameters in comparison with the baseline readings. Serum parameters such as BDNF, L and Z concentrations will also be assessed and compared with the baseline levels.

Conditions

• Cognitive

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Lutemax 2020 gummies	Lutein 10 mg \& Zeaxanthin isomers 2 mg
OTHER	Placebo	Placebo gummies

Timeline

• Start date: 2022-07-21
• Primary completion: 2023-01-27
• Completion: 2023-01-27
• First posted: 2026-01-21
• Last updated: 2026-01-21

Locations

1 site across 1 country: India