UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000053365 |
|---|---|
| Receipt number | R000060908 |
| Scientific Title | Exploratory study of the effect of oligosaccharide intake on gut microbiota, blood marker, and physical condition |
| Date of disclosure of the study information | 2024/01/19 |
| Last modified on | 2024/01/16 13:18:51 |
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Basic information
Public title
Exploratory study of the effect of oligosaccharide intake on gut microbiota, blood marker, and physical condition
Acronym
Exploratory study of the effect of oligosaccharide intake on gut microbiota, blood marker, and physical condition
Scientific Title
Exploratory study of the effect of oligosaccharide intake on gut microbiota, blood marker, and physical condition
Scientific Title:Acronym
Exploratory study of the effect of oligosaccharide intake on gut microbiota, blood marker, and physical condition
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of four weeks of oligosaccharide intake on gut microbiota, blood marker, and physical condition
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
gut microbiota
Key secondary outcomes
fecal organic acid concentration, fecal bile acid concentration, blood marker, physical conditions (height, body weight, BMI, muscle mass, body fat mass, body fat percentage, blood pressure), and incidence of adverse events
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
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral ingestion of oligosaccharide for four 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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Those who provided specimens in which oligosaccharide increased the number of useful bacteria in vitro
2.Those who belongs to R&D division on the date of consent
3.Those who have received sufficient explanation about the purpose and content of this study, have the consent ability and good understandings, and have agreed voluntarily to participate in the study
Key exclusion criteria
1.Those who have participated in other intervention studies in the month prior to screening or who plan to participate in other intervention studies during the period from screening to the end of the intake period
2.Those who have a history of gastric or lower gastrointestinal tract surgery excluding hemorrhoids
3.Those who have a barium stomach X-ray, small or large intestine endoscopy, or bowel cleansing at a clinic or at home in the month prior to screening or who plan to have these procedures during this study
4.Those who have taken, ingested, or used drugs that may affect the study at least once a week in the month prior to screening, or who plan to take, ingest, or use these drugs at least once during the study
5.Those who plan to travel abroad, travel for more than one week, or go on a business trip during the period from one week prior to the intake period to the end of the intake period
6.Those with lactose intolerance
7.Those with milk allergy
8.Females who are pregnant and/or lactating
9.Those judged as unsuitable for the study by the principal investigator or research physician for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5838
seiya.makino@meiji.com
Public contact
Name of contact person
| 1st name | Seiya |
| Middle name | |
| Last name | Makino |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
TEL
042-632-5838
Homepage URL
seiya.makino@meiji.com
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji 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
Meiji Institutional Review Board
Address
1-29-1 Nanakuni, Hachiouji, Tokyo
Tel
042-632-5900
MEIJI.IRB@meiji.com
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 | 01 | Month | 19 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 12 | Month | 14 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 01 | Month | 26 | Day |
Last follow-up date
| 2024 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 01 | Month | 16 | Day |
Last modified on
| 2024 | Year | 01 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000060908
| Research Plan | |
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| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
