UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000052468 |
|---|---|
| Receipt number | R000059449 |
| Scientific Title | Study on the impact of difructose anhydride III (DFA III) on bile acid metabolism in the human fecal microbiota |
| Date of disclosure of the study information | 2024/08/01 |
| Last modified on | 2023/12/19 17:12:36 |
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Basic information
Public title
Study on the effect of oligosaccharides on bile acid metabolism in the human gut microbiota
Acronym
Study of effectiveness of oligosaccharide on bile acids metabolism in gut microbiota
Scientific Title
Study on the impact of difructose anhydride III (DFA III) on bile acid metabolism in the human fecal microbiota
Scientific Title:Acronym
Study on bile acid metabolism of difructose anhydride III (DFA III)
Region
| Japan |
Condition
Condition
Healthy individuals(adults)
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective is to analyze changes in bile acid metabolism in the gut microbiota of healthy adult subjects after 10 days of DFA III (Difructose Anhydride III) consumption.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Evaluation of the ratio of secondary bile acids to primary bile acids in in vitro inoculation of fecal gut microbiota, both before and after 10 days of DFA III intake, at 0-24 hours of incubation, alongside primary bile salts.
Key secondary outcomes
Assessment of the quantity of individual bile acids in stool, as well as the gene expression of secondary bile acid metabolism enzymes, before and after 10 days of DFA III consumption.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
DFA III will be administered at a dosage of 4.0 grams twice a day, in the morning and evening, for a total of 10 days (8.0 grams per day).
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. Participants aged 20 and above of both genders.
2. Individuals who have received adequate explanation about the purpose and content of the study, and have provided written consent to participate.
Key exclusion criteria
Not applicable
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | Kyu-Ho |
| Middle name | |
| Last name | Han |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
080-8555
Address
Nishi 2 sen 11, Inada, Obihiro, Hokkaido
TEL
0155495561
kyuho@obihiro.ac.jp
Public contact
Name of contact person
| 1st name | Kyu-Ho |
| Middle name | |
| Last name | Han |
Organization
Obihiro University of Agriculture and Veterinary Medicine
Division name
Department of Life and Food Sciences
Zip code
080-8555
Address
Nishi 2 sen 11, Inada, 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
NIPPON BEET SUGAR MANUFACTURING CO., 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
Nishi 2 sen 11, Inada, 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
| 2024 | Year | 08 | 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
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
| 2023 | Year | 07 | Month | 21 | Day |
Date of IRB
| 2023 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2023 | Year | 10 | Month | 11 | Day |
Last follow-up date
| 2024 | Year | 01 | 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
| 2023 | Year | 10 | Month | 11 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059449
