UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000062105 |
|---|---|
| Receipt number | R000071053 |
| Scientific Title | Exploratory study on the effects of oligosaccharide intake on frailty indicators |
| Date of disclosure of the study information | 2026/07/01 |
| Last modified on | 2026/06/30 14:10:31 |
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Basic information
Public title
Exploratory study on the effects of oligosaccharide intake on frailty indicators
Acronym
Exploratory study on the effects of oligosaccharide intake on frailty indicators
Scientific Title
Exploratory study on the effects of oligosaccharide intake on frailty indicators
Scientific Title:Acronym
Exploratory study on the effects of oligosaccharide intake on frailty indicators
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
This randomized, placebo-controlled, double-blind, parallel-group exploratory study will enroll 100 healthy adults aged 65 years or older (50 participants in the test-food group and 50 participants in the control-food group) to evaluate the effects of continuous 24-week intake of oligosaccharides, a prebiotic, on the gut microbiota and frailty indicators.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Usual gait speed
Handgrip strength
Muscle mass
Key secondary outcomes
[Efficacy endpoints]
Body composition and bone-related parameters
Physical function (chair stand test and knee extension strength)
Gut environment-related parameters (gut microbiota and metabolites)
Blood biomarkers (inflammatory markers, intestinal barrier function markers, and endocrine- and aging-related markers)
Questionnaire-based assessments (frailty, health-related quality of life, mental and psychological status, physical activity, and bowel habits)
[Safety endpoints]
Number of adverse events, number of participants with adverse events, and incidence of adverse events attributable to the study, including subjective symptoms and objective findings
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
Prevention
Type of intervention
| Food |
Interventions/Control_1
Oral intake of an oligosaccharide-containing food for 24 weeks
Interventions/Control_2
Oral intake of a food in which oligosaccharide is replaced with dextrin for 24 weeks
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. Healthy Japanese men and women aged 65 years or older at the time of informed consent
2. Individuals who are aware of decreased muscle strength or reduced muscle mass
3. Individuals who have received sufficient explanation of the purpose and content of the study, have the capacity to provide consent, have adequately understood the study, and voluntarily agree to participate of their own free will
Key exclusion criteria
Subjects who meet any of the following criteria:
- Subjects with severe or progressive diseases (including hepatic impairment, renal or cardiac disease, pulmonary or gastrointestinal disorders, diabetes, rheumatoid arthritis, neurological or psychiatric disorders, etc.)
- Subjects with musculoskeletal disorders (including sarcopenia) or impaired walking ability
- Subjects with a history of gastrointestinal surgery that may affect the study outcomes
- Subjects who have undergone barium examination or intestinal cleansing (including colonoscopy) within 1 month prior to screening, or who plan to undergo such procedures during the study period
- Subjects currently undergoing diet or exercise therapy under medical supervision
- Subjects using medications that may affect the study outcomes (e.g., antibiotics, gastric acid suppressants, laxatives) or who plan to use them during the study period
- Subjects who regularly consume dietary supplements or foods for specified health uses that may affect the study outcomes and are unable to discontinue them during the study period
- Subjects with food allergies
- Subjects with excessive smoking (21 cigarettes/day or more) or alcohol consumption (40 g of ethanol/day or more)
- Subjects with irregular lifestyles due to shift work or night work
- Subjects with excessive exercise habits (e.g., resistance training 4 times/week or more)
- Subjects planning major lifestyle changes or long-term travel (including overseas travel or trips exceeding 1 week) during the study period
- Subjects with implanted medical devices (e.g., metal implants, pacemakers) or with a history of electrocardiogram abnormalities
- Subjects who have participated in other clinical studies within 1 month prior to consent, are currently participating, or plan to participate during the study period
- Subjects deemed inappropriate for participation by the principal investigator or sub-investigators
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Akika |
| Middle name | |
| Last name | Nagira |
Organization
Meiji Co., Ltd.
Division name
R&D Division
Zip code
192-0919
Address
1-29-1 Nanakuni, Hachiouji, Tokyo, Japan
TEL
042-632-5847
akika.nagira.aa@meiji.com
Public contact
Name of contact person
| 1st name | Makoto |
| Middle name | |
| Last name | Ichinohe |
Organization
CPCC Company Limited
Division name
Clinical Planning Department
Zip code
103-0021
Address
4F Daiwa Building, 3-3-10 Nihonbashi-Hongoku-Cho, Chuo-ku, Tokyo, Japan
TEL
03-6225-9001
Homepage URL
cpcc-contact@cpcc.co.jp
Sponsor or person
Institute
Meiji Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Meiji Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Meiji Holdings Co., Ltd., Chiyoda Paramedical Care Clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Chiyoda Paramedical Care Clinic Institutional Review Board
Address
Daiwa Building 2F, 3-3-10 Nihonbashi Hongokucho, Chuo-ku, Tokyo, Japan
Tel
03-6225-9005
IRB@cpcc.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
チヨダパラメディカルケアクリニック（東京都）
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
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 | 05 | Month | 29 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 29 | Day |
Anticipated trial start date
| 2026 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 04 | Month | 23 | 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 | 06 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000071053
