UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000060365 |
|---|---|
| Receipt number | R000069057 |
| Scientific Title | The effect of soy TVP consumption on the gut microbiota |
| Date of disclosure of the study information | 2026/01/15 |
| Last modified on | 2026/01/15 15:30:34 |
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Basic information
Public title
The effect of soy TVP consumption on the gut microbiota
Acronym
The effect of soy TVP consumption on the gut microbiota
Scientific Title
The effect of soy TVP consumption on the gut microbiota
Scientific Title:Acronym
The effect of soy TVP consumption on the gut microbiota
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Not applicable |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The objective of this study is to exploratively evaluate the impact of continuous four-week consumption of soy TVP on the gut microbiota and quality of life (QOL) in healthy adult men and women.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Fecal microbiota
Key secondary outcomes
Quality of Life (QOL) questionnaires
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -but assessor(s) are blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Participants will consume the test food (15g) for four weeks without specified timing or frequency
Interventions/Control_2
Participants will maintain their normal lifestyle without consuming the test food
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
| 18 | years-old | <= |
Age-upper limit
| 65 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1.Persons who received a sufficient explanation of the purpose and contents of the research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate
2.Persons who are Japanese citizens, aged 18 or older and under 65 at the time of consent
3.Persons who do not have intestinal diseases (including those who are judged not to require immediate treatment)
Key exclusion criteria
1.Persons who may experience abdominal pain when eating foods containing soy TVP
2.Persons who have a current diagnosis of small or large intestinal disorders (including inflammatory gastrointestinal diseases such as IBD), a history of small or large bowel resection, or a future requirement for such surgical intervention.
3.Person who regularly consumes material containing soy TVP (three or more days per week) or has regularly consumed it within one month prior to the pre-screening examination.
4.Persons who have been diagnosed with malignant tumors, are currently receiving treatment for cranial nerve disorders, heart disease, kidney disease, diabetes, or thyroid dysfunction, or have a history of other serious illnesses, excluding illnesses like hypertension, which principal investigator determined will not affect the evaluation of the research
5.Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey)
6.Persons who are at risk of developing allergies related to the test foods
7.Persons who are judged unsuitable as research subjects based on their responses to a background survey
8.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research.
9.Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period
10.Persons who are judged to be ineligible by the principal investigator
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
takumitochiobiz@gmail.com
Public contact
Name of contact person
| 1st name | Takumi |
| Middle name | |
| Last name | Tochio |
Organization
BIOSIS Lab. Co., Ltd.
Division name
CEO
Zip code
470-1101
Address
Room 506, Building No. 11, 1-98 Dengakugakubo, Kutsukake-cho, Toyoake, Aichi, JAPAN
TEL
090-6904-6772
Homepage URL
takumitochiobiz@gmail.com
Sponsor or person
Institute
BIOSIS Lab. Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Showa Sangyo 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 Ethics Committee of Healthcare Systems Co., Ltd.
Address
1-14-18, Shirakane, Showa-ku, Nagoya, Aichi, JAPAN
Tel
03-6809-2722
soumu@hc-sys.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
| 2026 | Year | 01 | Month | 15 | 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
| 2025 | Year | 12 | Month | 22 | Day |
Date of IRB
| 2026 | Year | 01 | Month | 15 | Day |
Anticipated trial start date
| 2026 | Year | 01 | Month | 15 | Day |
Last follow-up date
| 2026 | Year | 06 | Month | 30 | 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 | 01 | Month | 15 | Day |
Last modified on
| 2026 | Year | 01 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000069057
