UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063026 |
|---|---|
| Receipt number | R000072146 |
| Scientific Title | Effects of Gut Microbiota Modulation on Body Composition in Middle-Aged and Older Adults |
| Date of disclosure of the study information | 2026/09/23 |
| Last modified on | 2026/09/23 12:26:47 |
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Basic information
Public title
Does Fructan Induced Modulation of the Gut Microbiota Improve Body Composition in Middle Aged and Older Adults?
Acronym
Association Between Fructan-Induced Gut Microbiota Modulation and Improvements in Body Composition
Scientific Title
Effects of Gut Microbiota Modulation on Body Composition in Middle-Aged and Older Adults
Scientific Title:Acronym
Association Between Fructan-Induced Gut Microbiota Modulation and Improvements in Body Composition
Region
| Japan |
Condition
Condition
Middle-Aged and Older Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
In middle-aged and older adults, we will analyze the gut microbiota and assess health-related outcomes, including body composition, physical function, depressive symptoms, and sleep status, to evaluate the effects of consuming a sweetener containing the prebiotics 1-kestose and inulin.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Participants in the prebiotic group will consume 17 g of an oligosaccharide-containing sweetener (3.4 g of 1-kestose and 8.5 g of inulin; 33 kcal) once daily with breakfast, while those in the placebo group will consume 10 g of maltose (33 kcal) once daily with breakfast. The intervention will continue for 8 weeks.
All participants will also be instructed to perform a prescribed 15-minute exercise program, consisting of stretching,calisthenics, amd aerobic exercises every day.
Before and after the intervention, body composition and physical function will be assessed, and questionnaires will be administered to evaluate depressive symptoms, sleep status, dietary habits, and exercise habits.
Key secondary outcomes
To assess genetic predisposition, polymorphisms in the beta-3 adrenergic receptor gene (ADRB3), which is involved in lipolysis; the uncoupling protein 3 gene (UCP3), which is associated with energy metabolism; and the mechanistic target of rapamycin gene (MTOR, formerly FRAP1), which is involved in muscle protein synthesis, will be analyzed. These genetic factors will be examined to explore interindividual differences in the effects of prebiotic supplementation on body composition.
Base
Study type
Interventional
Study design
Basic design
Parallel
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
Educational,Counseling,Training
Type of intervention
| Food |
Interventions/Control_1
Participants in the prebiotic group will consume 17 g of an oligosaccharide-containing sweetener (3.4 g of 1-kestose and 8.5 g of inulin; 33 kcal) once daily with breakfast. The intervention will continue for 8 weeks.
All participants will also be instructed to perform a prescribed 15-minute exercise program, consisting of stretching,calisthenics, and aerobic exercises every day.
Interventions/Control_2
Participants in the placebo group will consume 10 g of maltose (33 kcal) once daily with breakfast. The intervention will continue for 8 weeks.All participants will also be instructed to perform a prescribed 15-minute exercise program, consisting of stretching,calisthenics, and aerobic exercises every day.
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
| 40 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Participants without a physician-diagnosed gastrointestinal disease who provide written informed consent will be included.
Key exclusion criteria
Individuals with a physician-diagnosed gastrointestinal disease or those currently taking antibiotics will be excluded.
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
Department of Nutrition
Zip code
470-0196
Address
57 Takenoyama Iwasaki-cho Nisshin, 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
Department of Nutrition
Zip code
470-0196
Address
57 Takenoyama Iwasaki-cho Nisshin, 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
Kotoyo Fujiki
Funding Source
Organization
Nagoya University of Arts and Sciences
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
Nagoya University of Arts and Sciences
Address
57 Takenoyama Iwasaki-cho Nisshin, Aichi, Japan
Tel
0561-75-2573
kfujiki@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
名古屋学芸大学
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 09 | Month | 23 | 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
Open public recruiting
Date of protocol fixation
| 2026 | Year | 08 | Month | 26 | Day |
Date of IRB
| 2026 | Year | 08 | Month | 27 | Day |
Anticipated trial start date
| 2026 | Year | 08 | Month | 26 | Day |
Last follow-up date
| 2026 | Year | 12 | Month | 04 | 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 | 09 | Month | 23 | Day |
Last modified on
| 2026 | Year | 09 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072146
