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A Study on the Effects of Supplement Intake on Visual Function - A Randomized Double-Blind Parallel Group Comparison Trial

A Study on the Effects of Supplement Intake on Visual Function - A Randomized Double-Blind Parallel Group Comparison Trial - A Study on the Effects of Supplement Intake on Visual Function

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000056048
Enrollment
40
Registered
2024-11-23
Start date
2025-02-22
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy adults

Interventions

Participants will consume 2 capsules of the test supplement once daily with water or warm water without chewing. Participants will consume 2 capsules of the placebo supplement once daily with water

Sponsors

IMEQRD Co. Ltd.
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1.Age: 40 years or older, but younger than 65 years. 2.Men and women of Japanese nationality. 3.BMI between 18.5 kg/m2 and 30.0 kg/m2. 4.IOP less than 20.0 mmHg at the time of screening. 5.Capability to enter data into an electronic diary via a smartphone or PC. 6.Individuals who have received a sufficient explanation about the study's purpose and content, fully understood it, voluntarily consented to participate and provided written consent.

Exclusion criteria

Exclusion criteria: 1.Receiving treatment for any disease or taking medication (on-demand use allowed). 2.Undergoing dietary or exercise therapy under medical supervision. 3.History of eye surgery (retinal detachment, LASIK, ICL) or eye diseases, including normal-tension glaucoma. 4.Severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, or history thereof. 5.History of gastrointestinal surgery (appendectomy allowed). 6.Using medications, quasi-drugs, health foods, supplements, or foods with functional claims for eye care. 7.Regularly (three or more times a week) consuming over-the-counter medications, quasi-drugs, health foods, supplements, foods for specified health uses, or foods with functional claims (participation allowed if stopped post-consent). 8.Current or past history of drug or food allergies. 9.Eye allergy symptoms from November to March (including those at risk). 10.Excessive alcohol consumption (pure alcohol intake of 40g or more per day). 11.Excessive smoking (21 or more cigarettes per day). 12.Engaged in shift work with night shifts. 13.Planning significant lifestyle changes (diet, sleep, exercise) during the study period due to long-term travel, etc. 14.History of vagal reactions or frequent anemia symptoms after blood collection. 15.Currently pregnant or breastfeeding, or planning to become pregnant during the study period. 16.Participating in other clinical trials, or within 4 weeks of this study, or planning to participate in another clinical trial post-consent. 17.Donated blood components or 200 mL of whole blood within one month before the study. 18.Donated 400 mL of whole blood within three months before the study. 19.Total blood donation volume, including this study, exceeds 1200 mL within 12 months prior. 20.Considered inappropriate for the study by the principal or sub-investigators.

Design outcomes

Primary

MeasureTime frame
Intraocular pressure (IOP)

Secondary

MeasureTime frame
Contrast Sensitivity Quality of Life (QOL) Questionnaires (NEI VFQ-25, VAS, Anti-Aging QOL) Cellular Activity

Countries

Japan

Contacts

Public ContactYoshitada Hira

IMEQRD Co., Ltd. Planning and Sales Department

clinical-trial@imeqrd.co.jp0367045968

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026