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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000038520
Receipt No. R000043886
Scientific Title A clinical trial on improving effect of consumption of a beverage on stool frequency
Date of disclosure of the study information 2019/11/10
Last modified on 2019/11/08

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Basic information
Public title A clinical trial on improving effect of consumption of a beverage on stool frequency
Acronym A clinical trial on improving effect of consumption of a beverage on stool frequency
Scientific Title A clinical trial on improving effect of consumption of a beverage on stool frequency
Scientific Title:Acronym A clinical trial on improving effect of consumption of a beverage on stool frequency
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the improving effect of 21 days consumption of a beverage on stool in healthy adults with lower stool frequency.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Stool frequency
Key secondary outcomes Stool characteristics,fecal microbiota

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 Test meal : take a test beverage for 21days(118g/day).
Interventions/Control_2 Control meal : take a placebo beverage for 21days(118g/day).
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 Volunteer having screening test result and questionnaire result judged tobe appropriate for this study by investigator.
Key exclusion criteria 1.Diabetes under medical treatment.
2.Volunteers having diseases (e.g. liver,kindney,heart, blood diseases, and infections requiring the notification.)
3.volunteers received gresctomy, enterectomy, and gastro-intestinal diseases, juded to be inappropriatebfor this study.
4.pregnant,women having the possibility, and 1actating women.
5.Paticipants in order clinical trial.
6.Volunteers rejected participating in this study by chief investigator.
Target sample size 44

Research contact person
Name of lead principal investigator
1st name Kenichi
Middle name
Last name Watanabe
Organization Niigata Bio-Research Park, Inc.
Division name advisor
Zip code 956-0841
Address 316-2,Higashijima, Akiha-ku, Niigata City
TEL 0250-25-1196
Email wataken@med.niigata-u.ac.jp

Public contact
Name of contact person
1st name Hiroshi
Middle name
Last name Goto
Organization Niigata Bio-Research Park, Inc.
Division name Bussiness promotion division
Zip code 956-0841
Address 316-2,Higashijima, Akiha-ku, Niigata City, 956-0841,Japan
TEL 0250-25-1196
Homepage URL
Email goto@nbrp.co.jp

Sponsor
Institute Niigata Bio-Research Park, Inc.
Institute
Department

Funding Source
Organization HAKKAISAN BREWERY CO.,LTD.
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 NBRC Research Ethics Review Committee
Address 316-2,Higashijima, Akiha-ku, Niigata City, 956-0841,Japan
Tel 0250-25-1196
Email nbrp-food-navi@nbrp.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
2019 Year 11 Month 10 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
2019 Year 10 Month 23 Day
Date of IRB
Anticipated trial start date
2019 Year 11 Month 10 Day
Last follow-up date
2020 Year 05 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2019 Year 11 Month 08 Day
Last modified on
2019 Year 11 Month 08 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043886

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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