UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054776 |
|---|---|
| Receipt number | R000062583 |
| Scientific Title | Effects of consumption of the test food on visual acuity in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study |
| Date of disclosure of the study information | 2024/07/02 |
| Last modified on | 2025/02/14 11:34:35 |
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Basic information
Public title
Effects of consumption of the test food on visual acuity in healthy Japanese
Acronym
Effects of consumption of the test food on visual acuity in healthy Japanese
Scientific Title
Effects of consumption of the test food on visual acuity in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study
Scientific Title:Acronym
Effects of consumption of the test food on visual acuity in healthy Japanese
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To verify the effects of consumption of the test food on visual acuity in healthy Japanese
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
The measured value of dominant eye visual acuity at 12 weeks after intervention (12w) [Before and after visual display terminals (VDT) workload: The change from before to after VDT workload]
Key secondary outcomes
1. The change of dominant eye visual acuity from screening (before consumption; Scr) to 12w [Before and after VDT workload]
2. The measured value of dominant eye visual acuity at 12w, and the change from Scr [Before VDT workload, After VDT workload]
3. The measured values of binocular visual acuity and non-dominant eye visual acuity at 12w, and their changes from Scr [Before VDT workload, After VDT workload, Before and after VDT workload]
4. The measured values of binocular near visual acuity, dominant eye near visual acuity, non-dominant eye near visual acuity, binocular intraocular pressure, dominant eye intraocular pressure, non-dominant eye intraocular pressure, and an original questionnaire at 12w, and their change from Scr [Before VDT workload, After VDT workload, Before and after VDT workload]
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
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Intervention
No. of arms
2
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Duration: 12 weeks
Test food: Test food A
Interventions/Control_2
Duration: 12 weeks
Test food: Placebo food
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Japanese
2. Men or women
3. Adults
4. Healthy subjects
5. Individuals who feel eye strain when performing VDT operation
6. Individuals whose monocular visual acuity is 1.0 or better with the unaided eye or corrected eye (whichever is worse)
7. Individuals who do not wear contact lenses or who wear contact lenses but can change to glasses during this study (between the date of consent and the final examination)
8. Individuals who the difference of visual acuity from VDT load (after load-before load) are large negatively
Key exclusion criteria
1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, and myocardial infarction
2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)
3. Individuals who are currently undergoing treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases
4. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"
5. Individuals who are taking or using medications (including herbal medicines) and supplements
6. Individuals who are allergic to medicines and/or the test product related products
7. Individuals who are diagnosed with presbyopia, or have presbyopia in self-knowledge
8. Individuals who have eye disease, entropion or trichiasis
9. Individuals who apply eye drops for eye diseases
10. Individuals who have ametropia and have not been properly corrected
11. Individuals who have undergone laser in situ keratomileusis surgery
12. Individuals who have excessive astigmatism
13. Individuals who are pregnant, lactating, or planning to become pregnant during this study
14. Individuals who have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate another study during this study
15. Individuals who are judged as ineligible to participate in this study by the physician
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Takahiro |
| Middle name | |
| Last name | Yamada |
Organization
Ario Nishiarai Eye Clinic
Division name
Director
Zip code
123-0843
Address
2F Ario Nishiarai, 1-20-1, Nishiarai sakae-cho, Adachi-ku, Tokyo, Japan
TEL
03-5681-1133
dr_yamada@orthomedico.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Suzuki |
Organization
ORTHOMEDICO Inc.
Division name
R&D Department
Zip code
112-0002
Address
2F Sumitomo Fudosan Korakuen Bldg., 1-4-1, Koishikawa, Bunkyo-ku, Tokyo, Japan
TEL
03-3818-0610
Homepage URL
nao@orthomedico.jp
Sponsor or person
Institute
ORTHOMEDICO Inc.
Institute
Department
Personal name
Funding Source
Organization
BGG Japan Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Seishinkai, Takara Clinic
Nerima Medical Association, Minami-machi Clinic
Ario Nishiarai Eye Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The ethical committee of the Takara Clinic, Medical Corporation Seishinkai
Address
9F Taisei Bldg., 2-3-2, Higashi-gotanda, Shinagawa-ku, Tokyo, Japan
Tel
03-5793-3623
IRB@takara-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
医療法人社団盛心会 タカラクリニック (東京都)
Medical Corporation Seishinkai, Takara Clinic (Tokyo, Japan)
南町医院 (東京都)
Nerima Medical Association, Minami-machi Clinic (Tokyo, Japan)
アリオ西新井クリニック眼科 (東京都)
Ario Nishiarai Eye Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 07 | Month | 02 | 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
44
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
| 2024 | Year | 06 | Month | 12 | Day |
Date of IRB
| 2024 | Year | 06 | Month | 12 | Day |
Anticipated trial start date
| 2024 | Year | 07 | Month | 02 | Day |
Last follow-up date
| 2025 | Year | 02 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
<Statistical Analysis Details>
Subgroup analysis will be performed for the following four populations. All subgroups will be constructed based on full analysis set (FAS) or per protocol set (PPS).
a. Subgroup of individuals aged >=40 (40HSS)
b. Subgroup of individuals aged <40 (40LSS)
c. Subgroup of males (MSS)
d. Subgroup of females (FSS)
Management information
Registered date
| 2024 | Year | 06 | Month | 26 | Day |
Last modified on
| 2025 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062583
