Dry Eye Disease, Immunity
Conditions
Keywords
Lutein, Zeaxanthin, Elderberry, Ocular Health, Immunity
Brief 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).
Interventions
DIETARY_SUPPLEMENTTwinkle 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_SUPPLEMENTPlacebo
The placebo supplement was identical in composition but excluded the active ingredients.
Sponsors
UCSI University
Ecolite Group
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Masking description
To maintain blinding, placebo supplements were identical in appearance to the intervention supplements, and investigators remained unaware of the participants' group assignments.
Intervention model description
One group intervention and one group placebo, consumption of supplements for 20 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* presence of dry eye symptoms * age 18 years or older * ability to comprehend the study protocol and information provided by the investigators * provision of informed consent.
Exclusion criteria
* ongoing medical treatment for ocular diseases or conditions * use of certain medications, including hormone replacement therapy, antidepressants, and treatments for high blood pressure, acne, birth control, and Parkinson's disease * history of eye surgery within the past three months * pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ocular Health | 20 days | 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 |
| Immunity | 20 days | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lutein and zeaxanthin intakes | 20 days | 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. |
Countries
Malaysia
Outcome results
None listed