UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063293 |
|---|---|
| Receipt number | R000072421 |
| Scientific Title | Effects of Test Food Intake on Near Visual Function in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial |
| Date of disclosure of the study information | 2026/11/01 |
| Last modified on | 2026/10/15 13:53:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Test Food Intake on Near Visual Function in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial
Acronym
Effects of Test Food Intake on Near Visual Function in Healthy Adults
Scientific Title
Effects of Test Food Intake on Near Visual Function in Healthy Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Comparative Trial
Scientific Title:Acronym
Effects of Test Food Intake on Near Visual Function in Healthy Adults
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 24-week intake of the test food on visual function in adult men and women.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in amplitude of accommodation
Key secondary outcomes
Near visual acuity, refraction, pupil diameter, and questionnaire survey
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will take two tablets of the test food once daily for 24 weeks.
Interventions/Control_2
Participants will take two tablets of the placebo food once daily for 24 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 41 | years-old | <= |
Age-upper limit
| 49 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Age: 41 to 49 years
2.Healthy men and women
3.Participants who feel that near objects or small print have become difficult to see
4.Participants with a binocular uncorrected or corrected visual acuity of 1.0 or better
5.Non-smokers (those who have not smoked for at least 1 year)
6.Participants who are able to visit the study site between 8:30 and 10:30 or between 13:30 and 15:30 on weekdays
7.Participants who have received a full explanation of the purpose and procedures of the study, understand them, voluntarily volunteer to participate, and provide written informed consent
Key exclusion criteria
1.Participants with organic ocular disease other than refractive error, including a history thereof, or refractive or intraocular surgery
2.Participants with symptoms due to ocular dryness or dry eye
3.Participants with a history of pollinosis, including allergic conjunctivitis or rhinitis
4.Contact lens users
5.Participants receiving treatment for any disease or using medications, including Kampo medicines, except as-needed medications
6.Participants undergoing dietary or exercise therapy under medical supervision
7.Participants with a current or previous serious illness
8.Participants using medications, including eye drops, that may affect test results, such as visual function-improving drugs or those affecting pupil size or function, or regularly consuming health foods, such as visual function supplements. Those able to stop these during the study, from 1 week before screening, may participate.
9.Participants routinely performing eye care involving the periorbital area, such as heated eye masks
10.Participants habitually consuming citrus fruits, including marmalade, or vegetable or fruit juices, including green juice, twice or more weekly. Those able to stop these during the study, from 1 week before screening, may participate.
11.Participants with known or suspected allergy to the test food, its ingredients, other foods, or food additives
12.Shift workers with night shifts
13.Participants planning major lifestyle changes, including diet, sleep, or exercise, during the study
14.Participants planning overseas travel during the study
15.Pregnant or lactating participants, or those planning pregnancy during the study
16.Participants in another clinical study within 1 month before consent, currently, or planned during the study
17.Participants judged unsuitable by the principal investigator or investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Miyuki |
| Middle name | |
| Last name | Kubota |
Organization
Keio University
Division name
Keio University Global Research Institute
Zip code
252-0882
Address
5322 Endo, Fujisawa-shi, Kanagawa, Japan
TEL
+81-466-49-3404
myu.kubota@keio.jp
Public contact
Name of contact person
| 1st name | Eriko |
| Middle name | |
| Last name | Toda |
Organization
Shonan Keiiku Hospital
Division name
Department of Ophthalmology
Zip code
252-0816
Address
4360 Endo, Fujisawa-shi, Kanagawa, Japan
TEL
0466-48-0050
Homepage URL
keiiku.research@gmail.com
Sponsor or person
Institute
Keio University
Institute
Department
Personal name
Kubota Miyuki
Funding Source
Organization
Ministry of Education, Culture, Sports, Science and Technology
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
SOUKEN Co., Ltd.
Name of secondary funder(s)
Nagase Viita Co., Ltd.
IRB Contact (For public release)
Organization
Shiba Palace Clinic Ethics Review Committee
Address
6F, Daiwa A Hamamatsucho Building, 1-9-10 Hamamatsucho, Minato-ku, Tokyo, Japan
Tel
03-5408-1599
shiba_palace@s-palace-clinic.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 11 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Preinitiation
Date of protocol fixation
| 2026 | Year | 09 | Month | 03 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 03 | Day |
Anticipated trial start date
| 2026 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 07 | Month | 15 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 10 | Month | 15 | Day |
Last modified on
| 2026 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072421
