UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000061659 |
|---|---|
| Receipt number | R000070508 |
| Scientific Title | Study on the effects of test food on intestinal environment in elderly humans. |
| Date of disclosure of the study information | 2026/05/24 |
| Last modified on | 2026/05/21 11:23:25 |
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Basic information
Public title
Study on the effects of test food on intestinal environment in elderly humans.
Acronym
Study on the effects of test food on intestinal environment in elderly humans.
Scientific Title
Study on the effects of test food on intestinal environment in elderly humans.
Scientific Title:Acronym
Study on the effects of test food on intestinal environment in elderly humans.
Region
| Japan |
Condition
Condition
No
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of test food on intestinal environment.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indicator of intestinal environment
Key secondary outcomes
Physical examination (anthropometric measurements), clinical examination (hematological tests, biochemical tests), diary, side effects, adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of the test food (15g/day for 8 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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Individuals who are residents of elderly care facilities aged 65 and over
2) Individuals concerned about bowel movements
3) Individuals who can obtain consent from themselves or their family
Key exclusion criteria
1) Individuals who habitually take prebiotic supplements
2) Individuals who participated in other clinical trials within the past month.
3) Individuals judged inappropriate for the study by the principal.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Yasuyuki |
| Middle name | |
| Last name | Irie |
Organization
Okayama Prefectural University
Division name
Department of Nutritional Science, Faculty of Health and Welfare Science
Zip code
719-1197
Address
Kuboki 111, Soja, Okayama
TEL
0866-94-2151
yirie@fhw.oka-pu.ac.jp
Public contact
Name of contact person
| 1st name | Rikako |
| Middle name | |
| Last name | Inoue |
Organization
Okayama Prefectural University
Division name
Department of Nutritional Science, Faculty of Health and Welfare Science
Zip code
719-1197
Address
Kuboki 111, Soja, Okayama
TEL
0866-94-2146
Homepage URL
rinoue@fhw.oka-pu.ac.jp
Sponsor or person
Institute
Okayama Prefectural University
Institute
Department
Personal name
Funding Source
Organization
Matsutani Chemical Industry Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koyama Medical and Welfare Group
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Okayama Prefectural University Ethics Committee
Address
Kuboki 111, Soja, Okayama
Tel
0866-94-2111
kenkyu2@ad.oka-pu.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
特別養護老人ホーム 雪のほこら（神奈川県）
特別養護老人ホーム 宙のとびら（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 05 | Month | 24 | 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
20
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
No longer recruiting
Date of protocol fixation
| 2026 | Year | 03 | Month | 17 | Day |
Date of IRB
| 2026 | Year | 03 | Month | 17 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 25 | Day |
Last follow-up date
| 2026 | Year | 08 | Month | 02 | 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 | 05 | Month | 22 | Day |
Last modified on
| 2026 | Year | 05 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070508
