UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024957 |
|---|---|
| Receipt number | R000028713 |
| Scientific Title | Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties. |
| Date of disclosure of the study information | 2016/11/24 |
| Last modified on | 2019/11/26 17:31:40 |
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Basic information
Public title
Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties.
Acronym
Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties.
Scientific Title
Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties.
Scientific Title:Acronym
Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties.
Region
| Japan |
Condition
Condition
Not applicable
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the efficacy of dietary fiber-containing food on defecation frequency, stool amount and number of Bifidobacterium in feces as primary endpoints.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Defecation frequency, stool amount and number of Bifidobacterium in feces
Key secondary outcomes
Questionnaires on fecal properties and subjective symptoms
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
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Daily intake of control food for 14 days
Washout period (14 days or more)
Daily intake of test food for 14 days
Interventions/Control_2
Daily intake of test food for 14 days
Washout period (14 days or more)
Daily intake of control food for 14 days
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
| 69 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Japanese males and females from 20 to 70 years of age when consented.
(2) Subjects with a tendency for constipation (2 to 4 times of defecation per week).
(3) Subjects taking meals regularly.
(4) Subjects available at every designated visit.
(5) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Key exclusion criteria
(1) Subjects with hepatic, renal, cardiac or organ disorders or diabetes or other serious diseases.
(2) Subjects with a surgical history of digestive system (except appendicectomy)
(3) Subjects currently under treatment with chronic diseases.
(4) Subjects who regularly take intestinal drugs or health foods which may influence intestinal regulation (including Food for Specified Health Uses and Foods with Function Claims).
(5) Subjects who cannot abstain from taking laxatives during the study periods.
(6) Subjects who are pregnant or expect to become pregnant during the study or lactate.
(7) Subjects who work on midnight or irregular shifts.
(8) Subjects who regularly take excessive alcohol (equivalent or larger amount to 540 ml of Japanese sake or 1.5 L of 5% alcohol beer or such)
(9) Subjects judged as unsuitable for the study by the principal investigator for other reasons.
Target sample size
28
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Takano |
Organization
Medical Corporation Hokubukai
Division name
Utsukushigaoka Hospital
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
takano@ughp-cpc.jp
Public contact
Name of contact person
| 1st name | Takuya |
| Middle name | |
| Last name | Matsuda |
Organization
Medical Corporation Hokubukai
Division name
Utsukushigaoka Hospital
Zip code
004-0839
Address
61-1, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
TEL
011-882-0111
Homepage URL
wakimoto@ughp-cpc.jp
Sponsor or person
Institute
Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department
Personal name
Funding Source
Organization
KOBAYASHI Pharmaceutical Co., Limited
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
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, Sinei, Kiyota-ku, Sapporo, Hokkaido, Japan
Tel
0118820111
matsuda@csc-smo.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
| 2016 | Year | 11 | Month | 24 | Day |
Related information
URL releasing protocol
Evaluation of Dietary Fiber-Containing Food on Bowl Movement and Fecal Properties.
Publication of results
Unpublished
Result
URL related to results and publications
Safety was confirmed.
Number of participants that the trial has enrolled
28
Results
Safety was confirmed.
Results date posted
| 2019 | Year | 11 | Month | 26 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
(1) Japanese males and females from 20 to 70 years of age when consented.
(2) Subjects with a tendency for constipation (2 to 4 times of defecation per week).
(3) Subjects taking meals regularly.
(4) Subjects available at every designated visit.
(5) Subjects who agree to participate in this study and can put signature and date to informed consent form by themselves prior to the study.
Participant flow
28
Adverse events
Nothing
Outcome measures
Safety was confirmed.
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2016 | Year | 10 | Month | 20 | Day |
Date of IRB
| 2016 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 11 | Month | 24 | Day |
Last follow-up date
| 2017 | Year | 03 | Month | 07 | Day |
Date of closure to data entry
Date trial data considered complete
| 2017 | Year | 07 | Month | 22 | Day |
Date analysis concluded
| 2017 | Year | 08 | Month | 08 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 11 | Month | 22 | Day |
Last modified on
| 2019 | Year | 11 | Month | 26 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028713
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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