Eye Care Benefits of Anti-Aging Compound Capsules in Healthy Adults (Eye Care)
Exploring the Eye Care Benefits of Anti-aging Compound Capsules
This study aims to evaluate the eye care benefits of anti-aging compound capsules in healthy adults. Participants will consume anti-aging compound capsules containing botanical extracts, omega-3 fatty acids, vitamins, minerals, and hyaluronic acid for four weeks.
The primary outcome is the improvement of ocular discomfort and eye fatigue symptoms assessed using the Ocular Surface Disease Index (OSDI). Secondary outcomes include visual acuity, accommodative function, tear film stability, macular pigment optical density, intraocular pressure, and photostress recovery time. The study will investigate whether daily supplementation with anti-aging compound capsules can improve visual comfort and support ocular health.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Szczegółowy opis
Visual fatigue and ocular discomfort have become increasingly prevalent due to prolonged use of digital devices, environmental stressors, and age-related changes in visual function. Nutritional supplementation containing antioxidants, carotenoids, omega-3 fatty acids, vitamins, minerals, and other bioactive compounds may help maintain ocular health and visual performance.
This prospective, single-arm, open-label clinical study aims to evaluate the eye care benefits of anti-aging compound capsules in healthy adults. Twenty-five participants will be enrolled and instructed to consume anti-aging compound capsules for four consecutive weeks.
Each capsule contains 550 mg of a proprietary formulation consisting of grape skin extract, marigold flower extract, red algae extract, fish oil, black soybean seed coat extract, Streptococcus fermentation products containing sodium hyaluronate, black pepper extract, zinc glycinate, selenium yeast, vitamins A, B1, B2, B6, B12, niacin, vitamin E, soybean lecithin, and glycerol fatty acid esters.
Participants will consume two capsules twice daily for a total daily intake of 2,200 mg. Ophthalmic assessments will be performed at baseline, Week 2, and Week 4.
The primary outcome measure is the Ocular Surface Disease Index (OSDI) score. Secondary outcome measures include distance visual acuity, near visual acuity, accommodative response, accommodative facility, tear film break-up time, macular pigment optical density, intraocular pressure, and photostress recovery time.
The study aims to determine whether supplementation with anti-aging compound capsules can improve eye fatigue symptoms and support ocular health in healthy adults.
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Taichung, Tajwan
- Department of Optometry, Chung Shan Medical University
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- Adults aged 20 to 60 years. Willing to participate in the study and able to provide written informed consent.
Spherical equivalent refractive error less than 700 diopters of myopia (i.e., < -7.00 D).
Exclusion Criteria:
- Regular consumption within the past 1 month of dietary supplements primarily indicated for eye health, or products containing active ocular health-related ingredients that may influence study outcomes (e.g., high-dose lutein ≥10 mg/day or zeaxanthin ≥2 mg/day). Use of general multivitamins or non-eye-specific supplements containing low-dose related ingredients (≤2 mg) may be allowed at the discretion of the investigators.
History of ocular infection or ocular surgery within the past 3 months. Clinically diagnosed ocular diseases, including but not limited to glaucoma, cataract, age-related macular degeneration, or diabetic retinopathy, or a history of ocular procedures such as cataract surgery, retinal laser therapy, or refractive surgery (e.g., LASIK).
Known or self-reported hypersensitivity or allergic reaction to any component of the investigational product, including but not limited to fish oil, soybean-derived products, gelatin (bovine source), yeast, or any other listed ingredients.
Individuals with direct affiliation, supervisory, evaluative, or dependent relationships with the research team, including but not limited to:
Students taught, supervised, or evaluated by members of the research team; Laboratory or research assistants, staff, or collaborators within the same research unit; Interns, part-time workers, or employees under the supervision of the research team.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie podtrzymujące
- Przydział: Nie dotyczy
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Eksperymentalny: Anti-Aging Compound Capsules
Participants will receive anti-aging compound capsules containing botanical extracts, omega-3 fatty acids, vitamins, minerals, and hyaluronic acid for 4 weeks.
Participants will take 2 capsules twice daily (total daily dose 2,200 mg).
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Participants will consume anti-aging compound capsules twice daily for 4 weeks.
Each capsule contains 550 mg of a proprietary formulation consisting of grape skin extract, marigold flower extract, red algae extract, fish oil, black soybean seed coat extract, Streptococcus fermentation products containing sodium hyaluronate, black pepper extract, zinc glycinate, selenium yeast, vitamins A, B1, B2, B6, B12, niacin, vitamin E, soybean lecithin, and glycerol fatty acid esters.
Total daily intake is 2,200 mg.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Ocular Surface Disease Index (OSDI) Score
Ramy czasowe: baseline / week2 / week4
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Changes in ocular discomfort and eye fatigue symptoms will be assessed using the Ocular Surface Disease Index (OSDI) questionnaire.
The OSDI is a validated 12-item questionnaire used to evaluate symptoms related to ocular surface disease and visual function.
Assessments will be performed at baseline, Week 2, and Week 4. A decrease in OSDI score indicates improvement in ocular symptoms.
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baseline / week2 / week4
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Change in Distance Visual Acuity (DVA, logMAR)
Ramy czasowe: baseline / week2 / week4
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Changes in distance visual acuity will be measured using a Snellen chart at 6 meters and converted to logarithm of the minimum angle of resolution (logMAR) for statistical analysis.
Assessments will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Near Visual Acuity (NVA)
Ramy czasowe: baseline / week2 / week4
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Changes in near visual acuity will be assessed using a Snellen near-vision chart at a distance of 40 cm.
Assessments will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Accommodative Response
Ramy czasowe: baseline / week2 / week4
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Accommodative response will be measured using a Shin-Nippon NVision-K5001 open-field autorefractor, including accommodative lag and accommodative lead.
Measurements will be conducted at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Accommodative Facility (cycles per minute)
Ramy czasowe: baseline / week2 / week4
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Accommodative facility will be assessed using ±0.50 diopter flipper lenses with standard accommodative targets.
Results will be recorded as cycles per minute (CPM).
Assessments will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Tear Film Break-Up Time (TBUT)
Ramy czasowe: baseline / week2 / week4
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Tear film stability will be evaluated using non-invasive tear break-up time measured by a corneal topography system (Topcon CA-800).
Assessments will be conducted at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Macular Pigment Optical Density (MPOD)
Ramy czasowe: baseline / week2 / week4
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Macular pigment optical density will be measured using a macular pigment optical density analyzer.
Assessments will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Change in Photostress Recovery Time
Ramy czasowe: baseline / week2 / week4
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Photostress recovery time will be assessed by measuring the time required for visual function to return to baseline following exposure to a standardized bright light stimulus.
Assessments will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
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Change in Intraocular Pressure (IOP)
Ramy czasowe: baseline / week2 / week4
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Intraocular pressure will be measured using non-contact tonometry.
Measurements will be performed at baseline, Week 2, and Week 4.
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baseline / week2 / week4
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Współpracownicy i badacze
Śledczy
- Główny śledczy: Lin, associated professor, Institute of Medical Research, Chung Shan Medical University
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- CS1-25234
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Opis planu IPD
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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