UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056684 |
|---|---|
| Receipt number | R000064788 |
| Scientific Title | Examination of the effect of test food on intestinal microbiota and mental and physical health -Single-arm study- |
| Date of disclosure of the study information | 2025/01/14 |
| Last modified on | 2025/01/10 14:56:39 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Examination of the effect of test food on intestinal microbiota and mental and physical health
-Single-arm study-
Acronym
Examination of the effect of test food on intestinal microbiota and mental and physical health
Scientific Title
Examination of the effect of test food on intestinal microbiota and mental and physical health
-Single-arm study-
Scientific Title:Acronym
Examination of the effect of test food on intestinal microbiota and mental and physical health
Region
| Japan |
Condition
Condition
Healthy adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Examining the effect of test food on intestinal microbiota and mental and physical health.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Intestinal mictobiota
Key secondary outcomes
physical measurement
QOL questionnaire
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
The test food is taken every morning.
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.Age between 20 and 65 years old at the time of informed consent
2.Male and Female
3.Those who received the sufficient explanation for the objective and summary of the trial, voluntarily decided to participate in the trial after understanding the purpose and made the written agreement
Key exclusion criteria
1.Those with a current or past history of serious illness
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
aabe@taiyokagaku.co.jp
Public contact
Name of contact person
| 1st name | Aya |
| Middle name | |
| Last name | Abe |
Organization
Taiyo Kagaku Co., Ltd
Division name
Nutrition Division
Zip code
510-0844
Address
1-3 Takaramachi, Yokkaichishi, Mie, Japan
TEL
059-347-5411
Homepage URL
aabe@taiyokagaku.co.jp
Sponsor or person
Institute
Taiyo Kagaku Co., Ltd
Institute
Department
Personal name
Funding Source
Organization
Taiyo Kagaku 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
Taiyo Kagaku Co., Ltd Ethics review committee
Address
Takaramachi, Yokkaichishi, Mie, Japan
Tel
059-347-5400
jfunabashi@taiyokagaku.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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 01 | Month | 14 | 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
| 2024 | Year | 12 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 01 | Month | 14 | 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
| 2025 | Year | 01 | Month | 10 | Day |
Last modified on
| 2025 | Year | 01 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064788
