UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041665 |
|---|---|
| Receipt number | R000047556 |
| Scientific Title | Verification study of the effect of a single intake of the test food on dry eyes and eyestrain |
| Date of disclosure of the study information | 2021/09/12 |
| Last modified on | 2020/12/10 16:18:43 |
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Basic information
Public title
Verification study of the effect of a single intake of the test food on dry eyes and eyestrain
Acronym
Verification study of the effect of a single intake of the test food on dry eyes and eyestrain
Scientific Title
Verification study of the effect of a single intake of the test food on dry eyes and eyestrain
Scientific Title:Acronym
Verification study of the effect of a single intake of the test food on dry eyes and eyestrain
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy and safety of the test food on dry eye and eyestrain in healthy male and female subjects between the ages of 20 and 50 years old by single intake of the test food.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tear strage
Near point distance measurement
Key secondary outcomes
Tear layer destruction time
Questionnaire about eye symptoms
amount of saliva
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingest 100ml high concentration test beverage at room temperature
Interventions/Control_2
Ingest 100ml low concentration test beverage at room temperature
Interventions/Control_3
Ingest 100ml placebo beverage at room temperature
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
| 50 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. 20 to 49 years old (at the time of submission of an informed consent document).
2. Japanese male and female.
3. Those who have subjective symptoms of being dry in the condition of their eyes.
4. Those who have subjective symptoms of being tired in the condition of the eyes.
5. Those who can read QR codes using a smart phone.
6. Those who have been briefed on the clinical trial and whose written consent has been obtained.
Key exclusion criteria
1. Those who are currently receiving some types of drug (except for the drugs that are taken as needed). Cholinergic agonists and anticholinergic drugs are not allowed even for abortive use (e.g., for use in stomach medicine and treatment of hyperhidrosis).
2. Those who have some kind of eye treatment (including dry eye).
3. Those who have had eye surgery within one year of the screening test and those who are planning to have eye surgery (including LASIK surgery) during the study period
4. People with serious or progressive diseases or symptoms (such as those for which drugs are used regularly on a daily basis)
5. Those who take health foods (foods or supplements that affect the body's composition, or are intended to maintain or restore health).
6. Those who have a past and current medical history of drug or food allergy.
7. Those who are participating in or currently participating in another clinical trial within one month prior to obtaining consent.
8. Pregnant, wishing to become pregnant between the screening date and the end of the food study, and breastfeeding
9. Those who regularly take foods containing lactobacillus and who have ingested dairy products (yogurt, kefir, sour cream, cheese, fermented butter, lactic acid bacteria drinks) containing lactobacillus even once within the past 7 days.
10. Those who plan to take dairy products containing lactobacillus (yogurt, kefir, sour cream, cheese, fermented butter, lactic acid bacteria drink) from the screening date to the end of the test period.
11. People with hay fever
12. Those who the investigator has determined to be inappropriate for this study.
Target sample size
12
Research contact person
Name of lead principal investigator
| 1st name | Hidetoshi |
| Middle name | |
| Last name | Miyazaki |
Organization
Asahi Quality & Innovations, Ltd.
Division name
Core Technology Institute
Zip code
3020106
Address
1-1-21 Midori Moriya-city Ibaraki
TEL
0297-46-9498
hidetoshi.miyazaki@asahi-qi.co.jp
Public contact
Name of contact person
| 1st name | Hirokuni |
| Middle name | |
| Last name | Kayama |
Organization
imeQ RD inc.
Division name
Sales department
Zip code
104-0061
Address
6-2-1 Ginza Chuo-ku Tokyo Japan
TEL
03-6704-5968
Homepage URL
h-kayama@imeqrd.co.jp
Sponsor or person
Institute
imeQ RD inc.
Institute
Department
Personal name
Funding Source
Organization
Asahi Quality & Innovations, Ltd.
Organization
Division
Category of Funding Organization
Self funding
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
03-6205-6222
suda-clinic_irb@imeq.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
| 2021 | Year | 09 | Month | 12 | 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
Completed
Date of protocol fixation
| 2020 | Year | 08 | Month | 18 | Day |
Date of IRB
| 2020 | Year | 08 | Month | 25 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 13 | Day |
Last follow-up date
| 2020 | Year | 10 | 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
| 2020 | Year | 09 | Month | 03 | Day |
Last modified on
| 2020 | Year | 12 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047556
| Research Plan | |
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| Registered date | File name |
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