UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062490 |
|---|---|
| Receipt number | R000071527 |
| Scientific Title | Inulin-GBA-2 |
| Date of disclosure of the study information | 2026/08/06 |
| Last modified on | 2026/08/06 10:31:48 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effects of Inulin on the Gut Microbiota-Psychology-Behavior Axis
Acronym
Inulin-GBA-1
Scientific Title
Inulin-GBA-2
Scientific Title:Acronym
Inulin-GBA-3
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to investigate the associations between changes in the gut microbiota following long-term supplementation with the soluble dietary fiber inulin and changes in psychological status, physical activity, and behavioral change. As a secondary objective, changes in cognitive function will also be evaluated.
Basic objectives2
Bio-availability
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota at baseline, week 4, and week 8 of inulin supplementation
Key secondary outcomes
Cognitive tests, Physical activity, Stages of behavior change, Stress biomarkers, Tryptophan metabolism-related biomarkers, Inflammation-related biomarkers
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
Treatment
Type of intervention
| Food |
Interventions/Control_1
Inulin (20 g/day) for 8 weeks
(10 g in the morning and 10 g in the evening, dissolved in water)
Interventions/Control_2
maltodextrin (20 g/day) for 8 weeks
(10 g in the morning and 10 g in the evening, dissolved in water)
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
| 18 | years-old | <= |
Age-upper limit
| 40 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Healthy adutls
Key exclusion criteria
Chronic diseases, Current antibiotic use, History of gastrointestinal diseases
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Kumpei |
| Middle name | |
| Last name | Tanisawa |
Organization
Waseda University
Division name
Faculty of Sport Sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6848
tanisawa@waseda.jp
Public contact
Name of contact person
| 1st name | Miko |
| Middle name | |
| Last name | Maeda |
Organization
Graduate school, Waseda University
Division name
Graduate school of sports sciences
Zip code
359-1192
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
TEL
04-2947-6848
Homepage URL
maeda0929@ruri.waseda.jp
Sponsor or person
Institute
Waseda University
Institute
Department
Personal name
Funding Source
Organization
Waseda University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Graduate school, Waseda University
Address
2-579-15 Mikajima, Tokorozawa, Saitama 359-1192, Japan
Tel
04-2947-6848
maeda0929@ruri.waseda.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
| 2026 | Year | 08 | Month | 06 | 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
| 2026 | Year | 08 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 08 | Month | 06 | Day |
Last follow-up date
| 2026 | Year | 09 | 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
| 2026 | Year | 08 | Month | 06 | Day |
Last modified on
| 2026 | 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=R000071527
