UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053357 |
|---|---|
| Receipt number | R000060904 |
| Scientific Title | Effect of consumption of the test food on visual function A Randomized, Double-blind, Placebo-controlled, Parallel-group Study |
| Date of disclosure of the study information | 2024/02/16 |
| Last modified on | 2024/01/15 17:42:56 |
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Basic information
Public title
Effect of consumption of the test food on visual function
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Acronym
Effect of consumption of the test food on visual function
Scientific Title
Effect of consumption of the test food on visual function
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study
Scientific Title:Acronym
Effect of consumption of the test food on visual function
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of intake of the test food on visual function in healthy adults who are aware of their visual decline.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Evaluation of eye focusing
Key secondary outcomes
Evaluation of visual acuity, flicker fusion frequency, and visual analogue scale score
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Participants will intake one test beverages per day for twelve weeks. They will also get clinical tests before and 12 weeks after the beginning of the intervention.
Interventions/Control_2
Participants will intake one placebo beverages per day for twelve weeks. They will also get clinical tests before and 12 weeks after the beginning of the intervention.
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)Healthy Japanese men and women over 18 years old at the time of obtaining consent to participate in the study
2)Subjects who have given written consent(Consent to participate in MYCODE Research) to participate in MYCODE Research
3)Subjects who have be given sufficient explanation about the purpose and contents of this study, volunteer for voluntary participation with good understanding, and can consent to the study
4)Subjects who are aware of eye strain
Key exclusion criteria
1)Subjects with a history of alcoholism or mental illness
2)Subjects with insomnia
3)Subjects who have a habit of intaking supplements to improve visual function
4)Subjects who are receiving continuous pharmaceutical treatment
5)Subjects with previous and/or current medical history of serious disease (e.g. liver, kidney, heart, lung, blood)
6)Females who are pregnant and/or lactating, or those with willingness/intention to become pregnant during the study
7)Subjects that plan to have irregular life cycle (e.g. midnight shift work, long-term travel) and/or those with extremely irregular dining and sleep habits
8)Subjects who have a habit of intaking lactic acid bacteria beverages
9)Subjects who have a habit of intaking Food for Specified Health Uses and/or Foods with Functional Claims
10)Subjects with current or past experience of participating in other clinical studies and/or subjects who plan to participate in other clinical trials after obtaining consent to participate in the study
11)Subjects with refractive errors that have not been properly corrected
12)Subjects who have severe astigmatism
13)Subjects who have undergone LASIK surgery in the past
14)Subjects who are judged by the principal investigator to be unsuitable as the study
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Shoko |
| Middle name | |
| Last name | Sassa |
Organization
Allm Inc.
Division name
Medical DX Solutions Department
Zip code
1500043
Address
16F Shibuya Mark City West, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-4361-2650
IRB_dls@dena.com
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Tajima |
Organization
Allm Inc.
Division name
Medical DX Solutions Department
Zip code
1500043
Address
16F Shibuya Mark City West, 1-12-1 Dogenzaka, Shibuya-ku, Tokyo
TEL
03-4361-2650
Homepage URL
IRB_dls@dena.com
Sponsor or person
Institute
Allm Inc.
Institute
Department
Personal name
Funding Source
Organization
NISSIN YORK 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
DeNA Life Science, Inc. Ethics Review Committee
Address
Shibuya Scramble Square 2 Chome-24-12 Shibuya, Shibuya City, Tokyo
Tel
03-6758-7200
IRB_dls@dena.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
| 2024 | Year | 02 | 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
| 2023 | Year | 12 | Month | 20 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 20 | Day |
Anticipated trial start date
| 2024 | Year | 02 | Month | 16 | Day |
Last follow-up date
| 2024 | Year | 08 | Month | 04 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 15 | Day |
Last modified on
| 2024 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060904
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| Registered date | File name |
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