UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029577 |
|---|---|
| Receipt number | R000033790 |
| Scientific Title | Effect of test food consumption on tear secretion and physical condition. |
| Date of disclosure of the study information | 2017/10/17 |
| Last modified on | 2020/03/02 16:19:05 |
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Basic information
Public title
Effect of test food consumption on tear secretion and physical condition.
Acronym
Effect of test food consumption on tear secretion and physical condition.
Scientific Title
Effect of test food consumption on tear secretion and physical condition.
Scientific Title:Acronym
Effect of test food consumption on tear secretion and physical condition.
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Ophthalmology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To quantify the effect of continuous consumption of test food, which is cows' milk containing dietary fibers, on tear secretion and physical condition.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
BUT, Schirmer's test, Questionnaire about ocular symptoms
Key secondary outcomes
Fecal microbiota, breath hydrogen concentration, oxidative-stress marker in tear, and 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
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Subjects take 200mL test food every morning in daily life for 3 weeks.
Interventions/Control_2
Subjects take 200mL placebo every morning in daily life for 3 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.Healthy adults
2.Subjects who feel eye dryness
Key exclusion criteria
1. Subjects under treatment of eyes
2. Subjects who operated or plan an operation for eyes within three months of screening test
3. Subjects who have serious or progressive illness and symptom
4. Subjects who routinely take pharmaceutical, quasi drug or health food, which may influence the result of this trial (including foods containing oligosaccharide, dietary fiber, hydrogen water and supplements that produce hydrogen gas)
5. Subjects who can avoid the intake of milk and dairy products except test food from screening examination to three weeks later
6. Subjects who have food allergies or drug allergies
7. Subjects with serious lactose intolerance (diarrhea)
8. Subjects who have serious constipation which need to take cathartic drugs and laxative products
9. Subjects under treatment of dry eye
10. Subjects who were enrolled in other trails within one month of screening test
11. Female Subjects who are or might become pregnant
12. Subjects who have history of serious hepatic disorder, renal damage, or myocardial infarction
13. Subjects who have been receiving drug treatment
14. Subjects with severe anemia
15. Inappropriate cases evaluated by doctors
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Motoko |
| Middle name | |
| Last name | Kawashima |
Organization
Keio University School of Medicine
Division name
Department of Ophthalmology
Zip code
160-8582
Address
35, Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
TEL
03-3353-1211
motoko-k@a3.keio.jp
Public contact
Name of contact person
| 1st name | Yoshitada |
| Middle name | |
| Last name | Hira |
Organization
imeQ CO. Ltd.
Division name
CRO division
Zip code
169-0051
Address
a vous primus Bld, 2-14-6, nishiwaseda, Shinjuku-ku, Tokyo 169-0075
TEL
03-6205-6222
Homepage URL
y-hira@imeq.co.jp
Sponsor or person
Institute
Kyodo Milk Industry Co. Ltd.
Research Laboratories
Institute
Department
Personal name
Funding Source
Organization
Kyodo Milk Industry Co. Ltd.
Research Laboratories
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
Iryouhoujinsyadan Hakusuikai Suda Clinical Institutional Review Board
Address
2-8-14 Takadanobaba, Shinjuku-ku, Tokyo 169-0051, Japan
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
医療法人社団浩央会 国立さくら病院
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 10 | Month | 17 | 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
| 2017 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2017 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2017 | Year | 10 | Month | 17 | Day |
Last follow-up date
| 2017 | Year | 12 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
| 2018 | Year | 02 | Month | 09 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 10 | Month | 16 | Day |
Last modified on
| 2020 | Year | 03 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033790
