Efficacy of Twinkle Eyez Supplementation in Improving Ocular Health and Immunity
NCT ID: NCT06574685
Last Updated: 2024-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
110 participants
INTERVENTIONAL
2024-07-01
2024-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
DOUBLE
Study Groups
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Twinkle Eyez Supplementation
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.
Placebo control
Placebo
The placebo supplement was identical in composition but excluded the active ingredients.
Interventions
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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.
Placebo
The placebo supplement was identical in composition but excluded the active ingredients.
Eligibility Criteria
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Inclusion Criteria
* age 18 years or older
* ability to comprehend the study protocol and information provided by the investigators
* provision of informed consent.
Exclusion Criteria
* 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
18 Years
ALL
Yes
Sponsors
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UCSI University
OTHER
Ecolite Group
INDUSTRY
Responsible Party
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Locations
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UCSI University
Cheras, Kuala Lumpur, Malaysia
Countries
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References
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Cena H, Roggi C, Turconi G. Development and validation of a brief food frequency questionnaire for dietary lutein and zeaxanthin intake assessment in Italian women. Eur J Nutr. 2008 Feb;47(1):1-9. doi: 10.1007/s00394-007-0689-0. Epub 2007 Dec 28.
Miller KL, Walt JG, Mink DR, Satram-Hoang S, Wilson SE, Perry HD, Asbell PA, Pflugfelder SC. Minimal clinically important difference for the ocular surface disease index. Arch Ophthalmol. 2010 Jan;128(1):94-101. doi: 10.1001/archophthalmol.2009.356.
Verster JC, Kraneveld AD, Garssen J. The Assessment of Immune Fitness. J Clin Med. 2022 Dec 20;12(1):22. doi: 10.3390/jcm12010022.
Frings A, Ziaei M, Lundstrom M, Allan BD. The Vision Correction Questionnaire: an electronic patient-reported outcome measure for refractive surgery. J Cataract Refract Surg. 2022 Dec 1;48(12):1427-1432. doi: 10.1097/j.jcrs.0000000000001018.
Other Identifiers
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ECO0001
Identifier Type: -
Identifier Source: org_study_id
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