UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062109 |
|---|---|
| Receipt number | R000071067 |
| Scientific Title | An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/07/01 15:59:03 |
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Basic information
Public title
An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly
Acronym
An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly
Scientific Title
An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly
Scientific Title:Acronym
An initiative for frailty prevention by improving intestinal environment in community-dwelling elderly
Region
| Japan |
Condition
Condition
Healthy elderly
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effects of 8-week intake of a prebiotic sweetener (containing inulin, kestose, and agaro-oligosaccharide) on dietary habits, gut microbiota (diversity, abundance of beneficial bacteria), and frailty-related factors (physical function, cognitive function, and nutritional status) in healthy elderly individuals residing in N City.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota
Key secondary outcomes
Health and nutritional status (Kihon Checklist, MNA-SF, CNAQ), exercise habits (IPAQ), body composition (body weight, body fat percentage, muscle mass), physical function (grip strength, gait speed, masticatory performance), cognitive function (reaction time, attention, visual learning, memory), and nutrient intake (BDHQ).
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
Daily intake of prebiotic sweetener (syrup containing inulin, kestose, and agaro-oligosaccharide) using a dedicated spoon (approx. 17g/day: containing 3.4g kestose, 8.5g inulin, and 17mg agaro-oligosaccharide) at breakfast 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
Healthy residents of N City aged 65 or older will be recruited through the city's public relations newsletter. Eligible participants include both men and women who have no physician-diagnosed gastrointestinal diseases and have provided written informed consent.
Key exclusion criteria
-
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | Kotoyo |
| Middle name | |
| Last name | Fujiki |
Organization
Nagoya University of Arts and Sciences
Division name
School of Nutritional Sciences, Department of Nutritional Sciences
Zip code
470-0196
Address
57 Takenoyama, Iwasaki-cho, Nisshin-shi, Aichi, Japan
TEL
0561-75-2573
kfujiki@nuas.ac.jp
Public contact
Name of contact person
| 1st name | Kotoyo |
| Middle name | |
| Last name | Fujiki |
Organization
Nagoya University of Arts and Sciences
Division name
School of Nutritional Sciences, Department of Nutritional Sciences
Zip code
470-0196
Address
57 Takenoyama, Iwasaki-cho, Nisshin-shi, Aichi, Japan
TEL
0561-75-2573
Homepage URL
kfujiki@nuas.ac.jp
Sponsor or person
Institute
Nagoya University of Arts and Sciences
Institute
Department
Personal name
Funding Source
Organization
Self-funding
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
The Research Ethics Committee of Nagoya University of Arts and Sciences.
Address
57 Takenoyama Iwasaki-cho Nisshin-city Aichi pref.
Tel
0561-75-7111
kitagawa@nuas.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
| 2026 | Year | 07 | Month | 01 | 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
21
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
| 2024 | Year | 08 | Month | 19 | Day |
Date of IRB
| 2024 | Year | 09 | Month | 23 | Day |
Anticipated trial start date
| 2024 | Year | 10 | Month | 22 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 07 | Month | 01 | Day |
Last modified on
| 2026 | Year | 07 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071067
