NCT06574685

Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 110 (actual)
• Sponsor: Ecolite Group · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, double-blind, placebo-controlled study that recruited 110 participants. The objectives of this study are to determine the dietary intake levels of lutein and zeaxanthin among precipitants. In additionally, this study also aimed to determine the efficacy of twinkle eyez supplementation in improving ocular health and immunity. The participant are required to take one sachet of twinkle eyez supplements or placebo for 20 days. The outcomes were assessed by food frequency questionnaire (FFQ), Ocular Surface Disease Index (OSDI), the Immune Status Questionnaire (ISQ), and the Visual Analogue Scale (VAS).

Conditions

• Dry Eye Disease
• Immunity

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Twinkle Eyez Supplementation	The intervention supplement consisted of marigold extract, zeaxanthin, elderberry extract, bilberry extract, lycopene extract, multivitamin, silicon dioxide, inulin, and dextrose monohydrate, all in powder form and packaged in individual sachets (Twinkle Eyez™; Xmegami, Selangor, Malaysia). Each sachet contained 4.6 mg of lutein and zeaxanthin and 15.4 mg of elderberry extract.
DIETARY_SUPPLEMENT	Placebo	The placebo supplement was identical in composition but excluded the active ingredients.

Timeline

• Start date: 2024-07-01
• Primary completion: 2024-07-31
• Completion: 2024-07-31
• First posted: 2024-08-28
• Last updated: 2024-08-28

Locations

1 site across 1 country: Malaysia