UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000044547 |
|---|---|
| Receipt number | R000050894 |
| Scientific Title | Effect of arabinoxylan intake on plasma acetate concentration (pilot study) |
| Date of disclosure of the study information | 2021/06/17 |
| Last modified on | 2022/06/21 09:12:25 |
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Basic information
Public title
Effect of arabinoxylan intake on plasma acetate concentration (pilot study)
Acronym
Effect of arabinoxylan intake on plasma acetate concentration (pilot study)
Scientific Title
Effect of arabinoxylan intake on plasma acetate concentration (pilot study)
Scientific Title:Acronym
Effect of arabinoxylan intake on plasma acetate concentration (pilot study)
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of arabinoxylan intake on plasma acetic acid concentration in healthy adults
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Tmax value of acetate after arabinoxylan intake
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
serial containing arabinoxylan intake (80g, once)
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
1. Subjects having an ability to understand study purpose and detail with voluntary written informed consent
2. Subjects having arabinoxylan assimilating bacteria
Key exclusion criteria
1. Subjects taking antibiotics or any drugs affect on microbiota
2. Subjects with food allergies, especially for wheat and/or milk
3. Pregnant women
4. Subjects participating or willing to participate in other clinical studies
5. Subjects judged as unsuitable for the study participant from other reasons
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Atsushi |
| Middle name | |
| Last name | Gomi |
Organization
Yakult Honsha Co., Ltd
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi Tokyo, Japan
TEL
042-577-8960
atsushi-gomi@yakult.co.jp
Public contact
Name of contact person
| 1st name | Chiaki |
| Middle name | |
| Last name | Kaga |
Organization
Yakult Honsha Co., Ltd
Division name
Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi Tokyo, Japan
TEL
042-577-8960
Homepage URL
chiaki-kaga@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Yakult Honsha 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
Chiyoda medical care clinic IRB
Address
3-3-5 Uchikanda, Chiyoda-ku Tokyo, Japan
Tel
03-5297-5548
IRB@cpcc.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
| 2021 | Year | 06 | Month | 17 | 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
Completed
Date of protocol fixation
| 2021 | Year | 05 | Month | 20 | Day |
Date of IRB
| 2021 | Year | 05 | Month | 21 | Day |
Anticipated trial start date
| 2021 | Year | 06 | Month | 21 | Day |
Last follow-up date
| 2021 | Year | 07 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2021 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2021 | Year | 06 | Month | 15 | Day |
Last modified on
| 2022 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050894
