UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035848 |
|---|---|
| Receipt number | R000040836 |
| Scientific Title | Clinical study on nutrient excretion |
| Date of disclosure of the study information | 2019/02/13 |
| Last modified on | 2019/12/19 10:48:20 |
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Basic information
Public title
Clinical study on nutrient excretion
Acronym
Clinical study on nutrient excretion
Scientific Title
Clinical study on nutrient excretion
Scientific Title:Acronym
Clinical study on nutrient excretion
Region
| Japan |
Condition
Condition
none
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This study aimed to verify the relationship among nutrients and background parameters of subject.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Relationship among measurement parameters
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Japanese aged from 20 to 70 years old
Key exclusion criteria
1. Subjects who have serious medical history and surgical history of resection of the gastrointestinal tract
2. Subjects who are not pregnant and breast feeding
3. Subjects who consume alcohol or excessive smoking
4. Subjects who are judged as unsuitable for the study by the principle doctor for other reason.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | Kei |
| Middle name | |
| Last name | Yui |
Organization
FANCL Corporation
Division name
Research Institute, Health science research center
Zip code
244-0806
Address
12-13 Kamishinano, Totsuka-ku, Yokohama, Kanagawa
TEL
045-820-3755
ke-yui@fancl.co.jp
Public contact
Name of contact person
| 1st name | Isao |
| Middle name | |
| Last name | Takehara |
Organization
Clinical Support Corporation Limited
Division name
PI/Food Service division
Zip code
150-0021
Address
4-1South 1 West 8, Chuo-ku, Sapporo city, Hokkaido, Japan
TEL
011-223-3130
Homepage URL
takehara@csc-smo.co.jp
Sponsor or person
Institute
FANCL Corporation
Institute
Department
Personal name
Funding Source
Organization
FANCL Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical Corporation Hokubukai Utsukushigaoka Hospital Institutional Review Board
Address
61-1, Shinei, Kiyota-ku, Sapporo, Hokkaido
Tel
011-882-0111
wakimoto@ughp-cpc.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
医療法人北武会 美しが丘病院
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 02 | Month | 13 | 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
316
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
| 2019 | Year | 01 | Month | 31 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 07 | Day |
Anticipated trial start date
| 2019 | Year | 02 | Month | 21 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
None
Management information
Registered date
| 2019 | Year | 02 | Month | 12 | Day |
Last modified on
| 2019 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040836
