UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000023028 |
|---|---|
| Receipt number | R000026540 |
| Scientific Title | Consideration of an effect food in bowel habits. |
| Date of disclosure of the study information | 2016/07/05 |
| Last modified on | 2018/10/03 11:38:02 |
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Basic information
Public title
Consideration of an effect food in bowel habits.
Acronym
Consideration of an effect food in bowel habits.
Scientific Title
Consideration of an effect food in bowel habits.
Scientific Title:Acronym
Consideration of an effect food in bowel habits.
Region
| Japan |
Condition
Condition
bowel habits
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine the relevance of the food for defecation ease and feces of shape.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Assessment
Primary outcomes
Evaluation item is carried out by the food record and defecation record.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
5
Purpose of intervention
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
The subjects are divided into five groups, split into four types of sample administrartion group and control group.
Interventions/Control_2
Samples1 are administered and evaluated.
Interventions/Control_3
Samples2 are administered and evaluated.
Interventions/Control_4
Samples3 are administered and evaluated.
Interventions/Control_5
Samples4 are administered and evaluated.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Subject is healthy, that you are not taking a laxative and antibiotic.
Key exclusion criteria
That it is taking laxatives and antibiotics.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Etsuro Tanaka |
Organization
Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science
Division name
Clinical Nutrition Laboratory
Zip code
Address
Setagaya-ku, Tokyo Sakuragaoka 1-1-1
TEL
03-5477-2455
etanaka-circ@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Etsuro Tanaka |
Organization
Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science
Division name
Clinical Nutrition Laboratory
Zip code
Address
Setagaya-ku, Tokyo Sakuragaoka 1-1-1
TEL
03-5477-2455
Homepage URL
etanaka-circ@umin.ac.jp
Sponsor or person
Institute
Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science Clinical Nutrition Laboratory
Institute
Department
Personal name
Funding Source
Organization
Tokyo University Of Agriculture Faculty Of Applied Bio-Science Nutritional Science Clinical Nutrition Laboratory
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
東京農業大学応用生物科学部栄養科学科臨床栄養学研究室
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 07 | Month | 05 | 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
| 2016 | Year | 07 | Month | 05 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 07 | Month | 05 | 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
| 2016 | Year | 07 | Month | 05 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000026540
