UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000058286 |
|---|---|
| Receipt number | R000066361 |
| Scientific Title | A verification Study on the Effects of Test Food Intake on Visual Function in Healthy Adults - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial - |
| Date of disclosure of the study information | 2025/06/26 |
| Last modified on | 2025/07/22 14:29:38 |
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Basic information
Public title
A verification Study on the Effects of Test Food Intake on Visual Function in Healthy Adults - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial -
Acronym
A verification Study on the Effects of Test Food Intake on Visual Function in Healthy Adults
Scientific Title
A verification Study on the Effects of Test Food Intake on Visual Function in Healthy Adults - Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparison Trial -
Scientific Title:Acronym
A verification Study on the Effects of Test Food Intake on 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 12 weeks of continuous consumption 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
Accommodation amplitude
Key secondary outcomes
Near visual acuity, Near point distance, Morphological measurement by Anterior segment OCT, Questionnaire survey, Pupil diameter
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
intake one tablet of test food once daily, for 12 weeks
Interventions/Control_2
intake one tablet of placebo food once daily, for 12 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
| 20 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1. Age: 20-60 years old
2. Healthy men or women
3. Individuals who feel difficulty seeing nearby objects or reading small text
4. Uncorrected or corrected visual acuity of 1.0 or higher in both eyes
5. No subjective symptoms of dry eye
6. Able to attend visits wearing glasses instead of contact lenses (soft or hard) on the day of the visit
7. Non-smokers (have not smoked for at least one year)
8. Capable of entering data into an electronic diary using a smartphone or PC
9. Individuals who have received sufficient explanation about the study's purpose and content, fully understand it, voluntarily wish to participate, and provide written informed consent
Key exclusion criteria
1. Individuals currently undergoing treatment for any disease with medication or herbal remedies (as-needed use permitted)
2. Individuals under dietary or exercise therapy supervised by a physician
3. Individuals who have a history of or currently have a severe diseases
4. Individuals who have a history of or currently have a organic ophthalmic diseases other than refractive errors, or those with a history of refractive correction surgery or intraocular surgery
5. Individuals taking or using medications (including eye drops) or supplements that may affect test results (e.g., those claiming to improve visual function or affecting pupil diameter/function), unless they can discontinue use during the study period (starting one week prior to screening).
6. Individuals who routinely use hot eye masks or similar care products
7. Individuals who habitually consume fruits (including processed food such as fruit jam) or vegetable/fruit juices (including green juice) more than twice a week, unless they can discontinue consumption during the study period (starting one week prior to screening).
8. Individuals with potential allergic reactions to the investigational food or its ingredients
9. Individuals working night shifts or rotating shifts
10. Individuals planning significant lifestyle changes (diet, sleep, exercise, etc.) during the study period
11. Individuals planning overseas travel during the study period
12. Pregnant or breastfeeding individuals, or those planning to become pregnant during the study period
13. Individuals who participated in another clinical study within one month prior to consent or are currently participating, or planning to participate during the study period
14. Individuals deemed unsuitable for participation by the principal investigator or study director
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hitoshi |
| Middle name | |
| Last name | Mitsuzumi |
Organization
Nagase Viita Co., Ltd.
Division name
Product Value Creation Department
Zip code
702-8006
Address
675-1 Fujisaki, Naka-ku, Okayama-shi, Okayama, Japan
TEL
086-276-3141
hitoshi.mitsuzumi@nagase.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
Nagase Viita Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
ROHTO Pharmaceutical Co., Ltd
IRB Contact (For public release)
Organization
Suda Clinic institutional review board
Address
2-8-14,Takadanobaba,Shinjuku,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
| 2025 | Year | 06 | Month | 26 | 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
No longer recruiting
Date of protocol fixation
| 2025 | Year | 05 | Month | 27 | Day |
Date of IRB
| 2025 | Year | 05 | Month | 27 | Day |
Anticipated trial start date
| 2025 | Year | 06 | Month | 27 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 07 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066361
