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Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity

NCT06574685 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 110

Last updated 2024-08-28

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • UCSI University

    collaborator OTHER

  • Ecolite Group

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-01
Primary Completion
2024-07-31
Completion
2024-07-31

Countries

  • Malaysia

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06574685 on ClinicalTrials.gov