UMIN-CTR Clinical Trial

Recruitment status Completed
Unique ID issued by UMIN UMIN000024957
Receipt No. 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 (Ver. 5)

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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
Email 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
Email wakimoto@ughp-cpc.jp

Sponsor
Institute Medical Corporation Hokubukai Utsukushigaoka Hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028713