UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000053179 |
|---|---|
| Receipt number | R000060256 |
| Scientific Title | Study on the Effect of Oligosaccharide Intake on Human Gut Microbiota and Its Influence on Organic Acid Production |
| Date of disclosure of the study information | 2023/12/20 |
| Last modified on | 2024/08/06 10:41:54 |
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Basic information
Public title
Study on the Effect of Oligosaccharide Intake on Human Gut Microbiota
Acronym
Study on the Effect of Oligosaccharide Intake on Human Gut Microbiota
Scientific Title
Study on the Effect of Oligosaccharide Intake on Human Gut Microbiota and Its Influence on Organic Acid Production
Scientific Title:Acronym
Study on the Effects of Oligosaccharide Intake on Human Gut Microbiota and Its Organic Acid Production
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of changes in gut microbiota and organic acid levels in stool following oligosaccharide intake. And evaluation of the production capacity of organic acids by gut microbiota through in vitro fecal culture tests.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
In a crossover intervention trial with a one-week washout period, this study aims to compare the gut microbiota in stool samples after a 14-day intake of an oligosaccharides (3g/day) and sugar (3g/day) as control using 16S rRNA amplicon sequencing analysis. And comparing effect of will be evaluatated among each diet on gut microbiota.
Key secondary outcomes
In a crossover intervention trial with a one-week washout period, the study involves the intake of the test food (3.0 g of oligosaccharides) and the control food (3.0 g of sucrose) for 14 days. After the consumption period, the gut microbiota in stool samples will be subjected to in vitro fecal culture for 0-24 hours, and the resulting organic acid levels will be evaluated using HPLC (High-Performance Liquid Chromatography). Additionally, the study will assess the levels of organic acid (HPLC) and IgA (enzyme-linked immunosorbent assay)in the stool.
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
The test food (containing 3.0 g of Oligosaccharides) will be consumed once a day for 14 days.
Interventions/Control_2
The control food (containing 3 g of sucrose) will be consumed once a day for 14 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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Adult male and female over 20 years old
2.Participants who have received sufficient explanation about the purpose and content of this study, understood it, and submitted written consent will be allowed to participate.
Key exclusion criteria
Not applicable
Target sample size
10
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
0808555
Address
Inada Nishi 2 sen 11, 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
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
NIPPON BEET SUGAR MANUFACTURING CO., LTD.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
NIPPON BEET SUGAR MANUFACTURING CO., LTD.
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
| 2023 | Year | 12 | Month | 20 | 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
10
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 | 12 | Month | 15 | Day |
Date of IRB
| 2023 | Year | 12 | Month | 19 | Day |
Anticipated trial start date
| 2023 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2024 | Year | 03 | 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
| 2023 | Year | 12 | Month | 20 | Day |
Last modified on
| 2024 | Year | 08 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000060256
