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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035553
Receipt No. R000040435
Scientific Title Effects of HBF2018-05 on Colon fermentability in healthy humans
Date of disclosure of the study information 2019/01/16
Last modified on 2019/07/05

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Basic information
Public title Effects of HBF2018-05 on Colon fermentability in healthy humans
Acronym Effects of HBF2018-05 on Colon fermentability in healthy humans
Scientific Title Effects of HBF2018-05 on Colon fermentability in healthy humans
Scientific Title:Acronym Effects of HBF2018-05 on Colon fermentability in healthy humans
Region
Japan

Condition
Condition Healthy Japanease adults
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 to investigate fermentability in large intestine by ingesting test food(HB2018-05)
Basic objectives2 Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hydrogen excretion after ingestion after ingesting test food
Key secondary outcomes

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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Oral ingestion of the test food(HBF2018-05) for 15 days
Interventions/Control_2 Oral ingestion of the control food(HBF2018-05) for 15 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
60 years-old >
Gender Male and Female
Key inclusion criteria 1)Healthy Japanease adults
2)Employees at the Hayashibara CO.,LTD.
3)Subjects who signed the informed consent for participation in the study
4)Individuals judged appropriate for the study by the principal investigator
Key exclusion criteria 1)Subjects with medical fistory of sever disorders
2)Pregnant or have possibility to become pregnant during the study or lactating women
3)Subjects who judged as unsuitable for this study by the principal investigator for any reasons
Target sample size 14

Research contact person
Name of lead principal investigator
1st name Akiko
Middle name
Last name Mizote
Organization Hayashibara CO., LTD.
Division name R&D Division, Food Materials Unit
Zip code 702-8006
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Email akiko.mizote@hb.nagase.co.jp

Public contact
Name of contact person
1st name Akiko
Middle name
Last name Mizote
Organization Hayashibara CO., LTD.
Division name R&D Division, Food Materials Unit
Zip code 702-8006
Address 675-1, Fujisaki, Naka-ku, Okayama
TEL 086-276-3141
Homepage URL
Email akiko.mizote@hb.nagase.co.jp

Sponsor
Institute Hayashibara CO., LTD.
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization The Ethics Committee of Hayashibara CO., LTD.
Address 675-1, Fujisaki, Naka-ku, Okayama
Tel 086-276-3141
Email akiko.date@hb.nagase.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 01 Month 16 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 14
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
2018 Year 10 Month 24 Day
Date of IRB
2018 Year 11 Month 14 Day
Anticipated trial start date
2019 Year 01 Month 16 Day
Last follow-up date
2019 Year 04 Month 01 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 01 Month 15 Day
Last modified on
2019 Year 07 Month 05 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040435

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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