UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045944 |
|---|---|
| Receipt number | R000052158 |
| Scientific Title | Evaluation of the effect of test food ingestion on eyesight |
| Date of disclosure of the study information | 2021/12/10 |
| Last modified on | 2022/11/18 11:16:00 |
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Basic information
Public title
Evaluation of the effect of test food ingestion on eyesight
Acronym
Evaluation of the effect of test food ingestion on eyesight
Scientific Title
Evaluation of the effect of test food ingestion on eyesight
Scientific Title:Acronym
Evaluation of the effect of test food ingestion on eyesight
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to assess the effect of continuous intake of test food on depth perception and dynamic vision by comparison with control food
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Depth perception and dynamic vision before and after the intervention of eye abuse task
Key secondary outcomes
Near vision acuity and distance vision acuity before and after the intervention of eye abuse task, and visual malaise questionnaire
Eye condition questionnaire
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingestion of test food for 8 weeks
Interventions/Control_2
Ingestion of placebo for 8 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
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Male and female adult aged 20 or more and less than 65 years old
2) Subject with bilateral distant vision (unaided eye) of 0.6 or higher
3) Subject who can use electronic diary application (e-DCA)
4) Subject who received sufficient explanation about the purpose and content of the trial, had the ability to consent, volunteered to participate after understanding it well, and agreed to participate in the trial in writing.
Key exclusion criteria
1) Subject who has serious disorders on brain, hepatic, kidney, cardiac, lung, digestive organs, blood, endocrine system, and metabolic system
2) Subject who is under medication on a steady basis or history of medication for serious disorders
3) Subject currently undergoing treatment or with digestive diseases that affect the study or have a surgical history of digestive system(except appendicectomy)
4) Subject who has ophthalmic disease, has an ophthalmic surgical history, or regularly use eye drops for treatment or prevention
5) Subject who has history of sensitivity to the ingredients of test food
6) Subject who takes medications and supplements on a daily basis *Except subject who can cancel an intake of health foods and supplements during this trial
7) Subject who is pregnant, lactating mother, or who is willing to become pregnant during this trial
8) Any candidates considered to be ineligible for enrollment due to the results of health condition questionnaire*1
9) Subject who took part in the other clinical/monitoring trial within a month before giving informed consent to take part in this trial.
10) Any candidates considered to be unsuitable for enrollment in the opinion of the principal investigator
*1:Those who smoke an average of 21 or more cigarettes in a day, drink an average of more than 20g of pure alcohol in a day more than 4 days a week, often skip two or more meals a day, work shifts at night etc.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kouji |
| Middle name | |
| Last name | Furunishi |
Organization
Kensou factory Co., Ltd.
Division name
-
Zip code
263-0021
Address
5-3-28 Todoroki-cho, Inage-ku, Chiba-shi, Chiba,Japan
TEL
080-9820-7352
okada.kf@gmail.com
Public contact
Name of contact person
| 1st name | Shigeru |
| Middle name | |
| Last name | Imai |
Organization
Leverage Brain Inc.
Division name
Clinical Trial Department
Zip code
105-0004
Address
Shinbashi2-16-1 Minato-ku, Tokyo, Japan
TEL
080-7290-0404
Homepage URL
imai@levbrain.com
Sponsor or person
Institute
Leverage Brain Inc.
Institute
Department
Personal name
Funding Source
Organization
Maruga Japan 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
Japan Conference of Clinical Research
Address
1-13-23 Minamiikebukuro Toshima-ku, Tokyo, Japan
Tel
03-6868-7022
jccr-info@cts-smo.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
| 2021 | Year | 12 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
50
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
| 2022 | Year | 10 | Month | 20 | Day |
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2021 | Year | 10 | Month | 05 | Day |
Date of IRB
| 2021 | Year | 10 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 12 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 03 | Month | 19 | Day |
Date of closure to data entry
| 2022 | Year | 03 | Month | 30 | Day |
Date trial data considered complete
| 2022 | Year | 04 | Month | 11 | Day |
Date analysis concluded
| 2022 | Year | 09 | Month | 16 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 01 | Day |
Last modified on
| 2022 | Year | 11 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052158
