UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062132 |
|---|---|
| Receipt number | R000071095 |
| Scientific Title | A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults - A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial - |
| Date of disclosure of the study information | 2026/07/16 |
| Last modified on | 2026/07/03 13:53:10 |
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Basic information
Public title
A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults
Acronym
A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults
Scientific Title
A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Scientific Title:Acronym
A Study on the Effects of a Test Food on Intraocular Pressure in Healthy Adults
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial -
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of 8-week continuous intake of the test food on intraocular pressure in middle-aged and older adults with relatively high intraocular pressure, using a randomized, placebo-controlled trial.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
-Intraocular pressure(IOP)
Key secondary outcomes
-Quality of Life (QOL) Questionnaires (NEI VFQ-25, VAS)
-Cellular Activity
-Blood pressure
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 consume 3 tablets of the test supplement once daily with water or warm water without chewing.
Interventions/Control_2
Participants will consume 3 tablets of the placebo supplement once daily with water or warm water without chewing.
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
| 50 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Age 50 to under 65 years at consent
2.Japanese men and women
3.IOP less than 20.0 mmHg at the time of screening
4.Capability to enter data into an electronic diary via a smartphone or PC
5.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.
Key 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.BMI <18.5 kg/m^2 or >=30.0 kg/m^2
4.Eye allergy symptoms from July to December (including those at risk)
5.History of eye surgery (retinal detachment, LASIK, ICL) or eye diseases, including normal-tension glaucoma.
6.Severe liver, kidney, heart, respiratory, endocrine, metabolic diseases, or history thereof.
7.History of gastrointestinal surgery (appendectomy allowed).
8.Using medications, quasi-drugs, health foods, supplements, or foods with functional claims for eye care.
9.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)
10.Current or history of drug or food allergies.
11.Excessive alcohol consumption (pure alcohol intake of 40 g or more per day)
12.Excessive smoking (21 or more cigarettes per day).
13.Extremely irregular diet or lifestyle, shift/night workers with irregular routines
14.Plans to significantly change lifestyle (diet, sleep, exercise) during the study
15.Plans for overseas travel during the study
16.Currently pregnant, breastfeeding, or planning pregnancy during the study
17.Symptoms of anemia
18.Donated blood components or 200 mL of whole blood within one month, or 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.Participation in another clinical study within 1 month before consent, currently participating, or planning to participate during the study
21.Deemed unsuitable for participation by the principal investigator
Target sample size
64
Research contact person
Name of lead principal investigator
| 1st name | Yoshinobu |
| Middle name | |
| Last name | Iwahana |
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Division name
Life Science Research Department, R&D Headquarters
Zip code
562-0029
Address
4-1-66 Saito Aokita, Minoh, Osaka, 562-0029, Japan
TEL
080-9181-6393
y.iwahana@kobayashi.co.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
IMEQRD Co., Ltd.
Division name
Planning and Sales Department
Zip code
104-0061
Address
6-2-1 Ginza, Chuo-ku, Tokyo, Japan
TEL
03-6704-5968
Homepage URL
clinical-trial@imeqrd.co.jp
Sponsor or person
Institute
IMEQRD Co. Ltd.
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14, Takadanobaba, Shinjyuku, Tokyo
Tel
03-6704-5968
jimukyoku@imeqrd.co.jp
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 | 07 | Month | 16 | 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 | 06 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 10 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 11 | 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 | 07 | Month | 03 | Day |
Last modified on
| 2026 | Year | 07 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071095
