UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000054619 |
|---|---|
| Receipt number | R000062410 |
| Scientific Title | Investigation of the effects of test-food consumption on the gut environment |
| Date of disclosure of the study information | 2025/05/20 |
| Last modified on | 2025/06/03 13:39:43 |
* 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
Investigation of the effects of test-food consumption on the gut environment
Acronym
Investigation of the effects of test-food consumption on the gut environment
Scientific Title
Investigation of the effects of test-food consumption on the gut environment
Scientific Title:Acronym
Investigation of the effects of test-food consumption on the gut environment
Region
| Japan |
Condition
Condition
Healthy Japanese
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The effects of test food consumption for 4 weeks on the gut environment will be evaluated
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Fecal short-chain fatty acids
Key secondary outcomes
1. Fecal microbiota
2. The status of defecation
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
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Consumption of test food 1 for 4 weeks
Interventions/Control_2
Consumption of test food 2 for 4 weeks
Interventions/Control_3
Consumption of placebo for 4 weeks
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. At informed consent, male/female subjects aged more than or equal to 20, and less than 65 years old
2. Subjects who defecate at least 3 times per week
3. Subjects who can show their understanding of the study procedure and agreement with participating in the study by written informed consent prior to the study
Key exclusion criteria
1. Subjects who regularly consume foods for specified health uses, foods with function claims, supplement and/or health foods, which would affect the trial results for more than 3 times a week, and who are unable to discontinue consumption from the day of the preliminary test
2. Subjects who have taken medications that would affect the study (e.g., bowel preparation, laxatives, etc.) for one month prior to the start of consumption of the test food, and who are unable to limit the use of such medications during the study period
3. Subjects who have taken antibiotics affecting the study for more than 2 months prior to the intervention period, and who cannot limit their use during the study period
4. Subjects who are currently undergoing other clinical trials with any kind of medicine/food, or who have participated in such trials within a month before this trial, or who will participate in such trials after giving informed consent to participate in this trial
5. Subjects with irregular dietary habits
6. Subjects who are expected to undergo major changes in their living environment, such as home and/or work, during this trial
7. Subjects whose roomer is planning to join this trial
8. Subjects who are smoker
9. Subjects who take excessive alcohol, defined as "drinkers whose average weekly alcohol intake exceeds 60 grams/day"
10. Subjects who had undergone appendectomy
11. Subjects who have received the surgery which would affect the trial result within half a year before obtaining a consent
12. Subjects who have previous/current medical history of severe cardiac, hepatic, renal or digestive diseases
13. Pregnant, possibly pregnant, or lactating women
14. Subjects who are allergic to medicines and/or foods
15. Others who have been determined ineligible by the study representative
Target sample size
39
Research contact person
Name of lead principal investigator
| 1st name | Motoyuki |
| Middle name | |
| Last name | Tagashira |
Organization
Asahi Group Foods, Ltd.
Division name
Technology Research&Development Department 1
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
0570-00-5112
motoyuki.tagashira@asahi-gf.co.jp
Public contact
Name of contact person
| 1st name | Misaki |
| Middle name | |
| Last name | Hatanaka |
Organization
Asahi Group Foods, Ltd.
Division name
Technology Research&Development Department 1
Zip code
302-0106
Address
1-1-21 Midori, Moriya-shi, Ibaraki, Japan
TEL
0570-00-5112
Homepage URL
misaki.hatanaka@asahi-gf.co.jp
Sponsor or person
Institute
Asahi Group Foods, Ltd.
Institute
Department
Personal name
Funding Source
Organization
Asahi Group Foods, Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Metagen, Inc.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Institutional Review Board of Chiyoda Paramedical Care Clinic
Address
2F Daiwa Building, 3-3-10 Nihonbashi-Hongokucho, Chuo-ku, Tokyo 103-0021, 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
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 05 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
36
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 | 05 | Month | 20 | Day |
Date of IRB
| 2024 | Year | 05 | Month | 17 | Day |
Anticipated trial start date
| 2024 | Year | 06 | Month | 12 | Day |
Last follow-up date
| 2024 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
| 2024 | Year | 11 | Month | 15 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2024 | Year | 06 | Month | 10 | Day |
Last modified on
| 2025 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000062410
