UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045510 |
|---|---|
| Receipt number | R000051940 |
| Scientific Title | Evaluation of the functionality of water-soluble beet fiber in humans |
| Date of disclosure of the study information | 2021/10/01 |
| Last modified on | 2021/09/17 22:40:58 |
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Basic information
Public title
Evaluation of the functionality of water-soluble beet fiber in humans
Acronym
Dietary fiber and gut microbiota
Scientific Title
Evaluation of the functionality of water-soluble beet fiber in humans
Scientific Title:Acronym
Dietary fiber and gut microbiota
Region
| Japan |
Condition
Condition
Gut function
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To analyze changes in the fecal microbiota when healthy subjects eat water-soluble beet fiber (SBF) for 2 weeks.
Basic objectives2
Others
Basic objectives -Others
To clarify the fermentability of SBF by human gut bacteria.
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
fermentability and microbiota
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
5 g daily (twice in the morning and evening) for 2 weeks
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Not applicable
Key exclusion criteria
diarrhea
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kyuho |
| Middle name | |
| Last name | Han |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
0808555
Address
Inada Nishi 2 Sen 11 Obihiro, Hokkaido
TEL
0155495561
kyuho@obihiro.ac.jp
Public contact
Name of contact person
| 1st name | Kyuho |
| Middle name | |
| Last name | Han |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
0808555
Address
Inada Nishi 2 Sen 11 Obihiro, Hokkaido
TEL
0155495561
Homepage URL
kyuho@obihiro.ac.jp
Sponsor or person
Institute
Obihiro University of Agriculture and Veterinary Medicine
Institute
Department
Personal name
Funding Source
Organization
Nitten ltd.
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
Obihiro University of Agriculture and Veterinary Medicine
Address
Inada Nishi 2 Sen 11 Obihiro, Hokkaido
Tel
0155495561
kyuho@obihiro.ac.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
| 2021 | Year | 10 | Month | 01 | 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
6
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Now preparing for submission
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
| 2020 | Year | 04 | Month | 15 | Day |
Date of IRB
| 2020 | Year | 06 | Month | 09 | Day |
Anticipated trial start date
| 2020 | Year | 09 | Month | 09 | Day |
Last follow-up date
| 2020 | Year | 10 | Month | 29 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 09 | Month | 17 | Day |
Last modified on
| 2021 | Year | 09 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051940
