UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060631 |
|---|---|
| Receipt number | R000069348 |
| Scientific Title | A Comparative Study on the Effects of Single Ingestion of High-Purity Galactooligosaccharides and OLIGOMATE 55N on Post-Ingestion Blood Glucose Levels |
| Date of disclosure of the study information | 2026/02/10 |
| Last modified on | 2026/02/09 21:56:07 |
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Basic information
Public title
Single Ingestion Study of Galactooligosaccharides
Acronym
Single Ingestion Study of Galactooligosaccharides
Scientific Title
A Comparative Study on the Effects of Single Ingestion of High-Purity Galactooligosaccharides and OLIGOMATE 55N on Post-Ingestion Blood Glucose Levels
Scientific Title:Acronym
A Comparative Study on the Effects of Single Ingestion of High-Purity Galactooligosaccharides and OLIGOMATE 55N on Post-Ingestion Blood Glucose Levels
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare post-ingestion changes in blood glucose levels after single administration of glucose, OLIGOMATE 55N, and high-purity galactooligosaccharides in healthy adults.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Post-ingestion changes in blood glucose levels
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Single administration of the control food, followed by a 1-week washout, then single administration of Test Food 1, followed by another 1-week washout, and finally single administration of Test Food 2.
Interventions/Control_2
Single administration of Test Food 1, followed by a 1-week washout, then single administration of Test Food 2, followed by a 1-week washout, and finally single administration of the control food.
Interventions/Control_3
Single administration of Test Food 2, followed by a 1-week washout, then single administration of the control food, followed by a 1-week washout, and finally single administration of Test Food 1.
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
| 60 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Healthy adults
Key exclusion criteria
(1) Individuals who are pregnant or may become pregnant
(2) Individuals who are participating in or planning to participate in another clinical or volunteer study during the study period
(3) Individuals with diabetes mellitus
(4) Individuals taking medications that may affect blood glucose levels
(5) Individuals who report having allergies to the test foods
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | Eiichiro |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Department, Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8969
eiichiro-naito@yakult.co.jp
Public contact
Name of contact person
| 1st name | Eiichiro |
| Middle name | |
| Last name | Naito |
Organization
Yakult Honsha Co., Ltd.
Division name
Food Research Department, Yakult Central Institute
Zip code
186-8650
Address
5-11 Izumi, Kunitachi-shi, Tokyo
TEL
042-577-8969
Homepage URL
eiichiro-naito@yakult.co.jp
Sponsor or person
Institute
Yakult Honsha Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ethical Review Committee for Research Involving Human Subjects, Yakult Honsha Co., Ltd.
Address
5-11 Izumi, Kunitachi-shi, Tokyo
Tel
042-577-8960
kenta-suzuki@yakult.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
| 2026 | Year | 02 | Month | 10 | 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
| 2025 | Year | 12 | Month | 17 | Day |
Date of IRB
| 2025 | Year | 12 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 02 | Month | 10 | Day |
Last follow-up date
| 2026 | Year | 03 | Month | 20 | 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 | 02 | Month | 09 | Day |
Last modified on
| 2026 | Year | 02 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069348
