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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000029577
Receipt No. 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 2017/10/16

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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
Middle name
Last name Motoko Kawashima
Organization Keio University School of Medicine
Division name Department of Ophthalmology
Zip code
Address 35, Shinanomachi, Shinjyuku-ku, Tokyo 160-8582
TEL 03-3353-1211
Email motoko-k@a3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yoshitada Hira
Organization imeQ CO. Ltd.
Division name CRO division
Zip code
Address a vous primus Bld, 2-14-6, nishiwaseda, Shinjuku-ku, Tokyo 169-0075
TEL 03-6205-6222
Homepage URL
Email y-hira@imeq.co.jp

Sponsor
Institute Kyodo Milk Industry Co. Ltd.
Research Laboratories
Institute
Department

Funding Source
Organization None
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
Address
Tel
Email

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 Preinitiation
Date of protocol fixation
2017 Year 10 Month 11 Day
Date of IRB
Anticipated trial start date
2017 Year 10 Month 17 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 10 Month 16 Day
Last modified on
2017 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033790

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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