- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07657936
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
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Taichung, Taiwan
- Department of Optometry, Chung Shan Medical University
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
Accetta volontari sani
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Terapia di supporto
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
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Sperimentale: 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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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Change in Ocular Surface Disease Index (OSDI) Score
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Change in Intraocular Pressure (IOP)
Lasso di tempo: 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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Collaboratori e investigatori
Investigatori
- Investigatore principale: Lin, associated professor, Institute of Medical Research, Chung Shan Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- CS1-25234
Piano per i dati dei singoli partecipanti (IPD)
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