UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000059802 |
|---|---|
| Receipt number | R000068378 |
| Scientific Title | A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment |
| Date of disclosure of the study information | 2025/11/17 |
| Last modified on | 2025/11/17 17:50:04 |
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Basic information
Public title
A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment
Acronym
A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment
Scientific Title
A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment
Scientific Title:Acronym
A study on the health effects of Bifidobacterium and inulin intake in an uncontrolled environment
Region
| Japan |
Condition
Condition
healthy adults
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effects of consuming a test food and performing regular body composition measurements on body fat in Japanese adults with a BMI of 23 kg/m2 or higher, without any specific lifestyle restrictions.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in body fat mass over 8 weeks (measured by Inbody)
Key secondary outcomes
Body composition (measured by Inbody) at weeks 0, 4, and 8; gut microbiota (relative abundance, diversity, etc.) at weeks 0 and 8; fecal short-chain fatty acid (SCFA) levels at weeks 0 and 8; bowel movement frequency, consistency, and volume; bristol stool scale; body composition (measured with a consumer body composition monitor) from weeks 0 to 8
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
1. 8-week continuous intake of a food containing bifidobacterium and inulin
2. Regular body composition measurements
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
| 20 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1. Male and female employees of Ezaki Glico Co., Ltd., aged 20 to 64 years
2.Subjects who have a body mass index (BMI) of 23.0 kg/m2 or higher
3.Subjects who have received sufficient explanation of the purpose and content of the study, have the capacity to consent, have voluntarily volunteered to participate based on a good understanding of the study, and have agreed to participate in the study in writing
Key exclusion criteria
1. Subjects who have used antibiotics within 2 weeks prior to the start of the study.
2. Subjects who are judged to have difficulty providing written informed consent for the study.
3. Subjects who are pregnant, planning to become pregnant during the study period, or are breastfeeding.
4. Subjects who have excessive alcohol consumption (an average daily intake of 60 g or more of pure alcohol).
5. Subjects who have a known allergy to the investigational food.
6. Subjects who are currently participating in another clinical trial.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Kensei |
| Middle name | |
| Last name | Morioka |
Organization
Ezaki Glico Co., Ltd.
Division name
Dairy Business Division
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
06-6477-8352
kensei.morioka@glico.com
Public contact
Name of contact person
| 1st name | Yuhei |
| Middle name | |
| Last name | Baba |
Organization
Ezaki Glico Co., Ltd.
Division name
Dairy Business Division
Zip code
555-8502
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
TEL
080-9596-0792
Homepage URL
yuhei.baba@glico.com
Sponsor or person
Institute
Ezaki Glico Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Ezaki Glico Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
The Institutional Review Board of Glico Group
Address
4-6-5 Utajima, Nishiyodogawa-ku, Osaka-shi, Osaka
Tel
06-6477-8352
kazunori.nishi@glico.com
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
| 2025 | Year | 11 | Month | 17 | 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 | 10 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 11 | Month | 18 | Day |
Last follow-up date
| 2025 | Year | 12 | 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
| 2025 | Year | 11 | Month | 17 | Day |
Last modified on
| 2025 | Year | 11 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000068378
