Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
NCT Number: NCT06574685
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dry Eye Disease|Immunity
Interventions: DIETARY_SUPPLEMENT: Twinkle Eyez Supplementation|DIETARY_SUPPLEMENT: Placebo
Sponsor: Ecolite Group
Collaborators: UCSI University
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 110
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-01
Completion Date: 2024-07-31
Locations: UCSI University, Cheras, Kuala Lumpur, 56000, Malaysia

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).

Primary Outcome Measures: Ocular Health, Ocular Surface Disease Index (OSDI) was used to assess the ocular health of participants. The OSDI, a validated 12-item questionnaire, assesses three subcategories: ocular symptoms, vision-related function, and environmental triggers. Each item is rated on a scale from 0 ('none of the time') to 4 ('all of the time'), with the final OSDI score calculated by summing the participant's responses, 20 days|Ocular Health, Visual Analogue Scale (VAS) was used to assess the ocular health of participants. The VAS is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity or general wellbeing of an individual, often used in epidemiological and clinical research. Participants were asked to self-rate their current overall ocular health using a 10 cm VAS, where 0 indicated a very poor condition and 10 indicated an excellent condition., 20 days|Immunity, Immune Status Questionnaire (ISQ) and Visual Analogue Scale (VAS) was used to assess the immunity status of participants. The ISQ consists of seven items that assess the occurrence of various immune-related symptoms in the past. The total ISQ score was recoded onto a scale from 0 (very poor) to 10 (excellent)., 20 days|Immunity, Visual Analogue Scale (VAS) was used to assess the immunity status of participants. The VAS is a psychometric measuring instrument designed to document the characteristics of disease-related symptom severity or general wellbeing of an individual, often used in epidemiological and clinical research. Participants were asked to self-rate their current overall immunity status using a 10 cm VAS, where 0 indicated a very poor condition and 10 indicated an excellent condition., 20 days
Secondary Outcome Measures: Lutein and zeaxanthin intakes, Dietary intakes of lutein and zeaxanthin over the previous six months were assessed using a validated, simplified food frequency questionnaire (FFQ) tailored to include 30 food items known for their lutein and zeaxanthin content (1). For each food item, a specific serving size was provided, and participants reported their consumption frequency in terms of 'never' or the number of occasions per day, week, or month, as appropriate. The dietary intake of lutein and zeaxanthin was then calculated based on values from the United States Department of Agriculture-National Cancer Institute Carotenoids Database., 20 days