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Eye Care Benefits of Anti-Aging Compound Capsules in Healthy Adults (Eye Care)

2026年6月14日 更新者:Hui Wen Lin、China Medical University Hospital

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.

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

25

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Taichung、台湾
        • Department of Optometry, Chung Shan Medical University

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人

接受健康志愿者

是的

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:支持治疗
  • 分配:不适用
  • 介入模型:单组作业
  • 屏蔽:无(打开标签)

武器和干预

参与者组/臂
干预/治疗
实验性的: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).
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.

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Change in Ocular Surface Disease Index (OSDI) Score
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Distance Visual Acuity (DVA, logMAR)
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Near Visual Acuity (NVA)
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Accommodative Response
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Accommodative Facility (cycles per minute)
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Tear Film Break-Up Time (TBUT)
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Macular Pigment Optical Density (MPOD)
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4
Change in Photostress Recovery Time
大体时间:baseline / week2 / week4
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.
baseline / week2 / week4

次要结果测量

结果测量
措施说明
大体时间
Change in Intraocular Pressure (IOP)
大体时间:baseline / week2 / week4
Intraocular pressure will be measured using non-contact tonometry. Measurements will be performed at baseline, Week 2, and Week 4.
baseline / week2 / week4

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Lin, associated professor、Institute of Medical Research, Chung Shan Medical University

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月30日

初级完成 (实际的)

2026年6月3日

研究完成 (实际的)

2026年6月10日

研究注册日期

首次提交

2026年6月14日

首先提交符合 QC 标准的

2026年6月14日

首次发布 (实际的)

2026年6月18日

研究记录更新

最后更新发布 (实际的)

2026年6月18日

上次提交的符合 QC 标准的更新

2026年6月14日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CS1-25234

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

IPD 计划说明

Individual participant data (IPD) will not be shared due to ethical and privacy considerations. The dataset includes ophthalmic measurements and health-related questionnaire data that could potentially identify participants. Data may be available upon reasonable request and with approval from the corresponding ethics committee.

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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