UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000063098 |
|---|---|
| Receipt number | R000072229 |
| Scientific Title | Effects of continuous intake of soy protein on gut microbiota and performance in athletes |
| Date of disclosure of the study information | 2026/09/29 |
| Last modified on | 2026/09/29 15:14:28 |
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Basic information
Public title
Effects of continuous intake of soy protein on gut microbiota and performance in athletes
Acronym
Effects of continuous intake of soy protein on gut microbiota and performance in athletes
Scientific Title
Effects of continuous intake of soy protein on gut microbiota and performance in athletes
Scientific Title:Acronym
Effects of continuous intake of soy protein on gut microbiota and performance in athletes
Region
| Japan |
Condition
Condition
Healthy Adults
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To exploratorily evaluate the effects of 4-week continuous intake of soy protein on intestinal environment, quality of life, and performance in adult male and female athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Gut microbiota in feces before intake or after 4 weeks of intake
Key secondary outcomes
Quality of life questionnaire (defecation status, etc.) and performance evaluation (various sports indicators) before intake or after 4 weeks of intake
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
Intake of approximately 20 grams of test food (processed soy protein food) once daily for 4 weeks
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
| 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 this study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Japanese male and female persons who are 18 years old or more and under 65 years old at the time of obtaining consent.
3. Persons who are athletes engaged in sports competitions or training on a daily basis.
4. Persons who do not have intestinal diseases (including those judged to have no immediate need for treatment).
Key exclusion criteria
1. Persons who may develop abdominal pain due to materials containing soy protein.
2. Persons currently diagnosed with small or large intestinal diseases (digestive diseases with inflammation of the small or large intestine, including inflammatory bowel disease), persons who have undergone resection of the small or large intestine, or persons who require resection of the small or large intestine in the future.
3. Persons who regularly consume materials containing soy protein (3 days or more per week) and persons who regularly consumed them within 1 month before the preliminary examination.
4. Persons diagnosed with malignant tumors, undergoing treatment for cranial nerve disease, heart disease, kidney disease, diabetes, or thyroid dysfunction, or having a history of serious diseases such as liver disease. However, diseases judged by the principal investigator to have no impact on the evaluation of this study, such as treatment for hypertension, are excluded.
5. Persons who consume large amounts of alcohol (60 grams or more of alcohol per day equivalent: corresponding to approximately 1500 milliliters of beer, approximately 540 milliliters of wine, approximately 3 go of sake, or approximately 180 milliliters of double whiskey).
6. Persons at risk of developing allergies related to the test food.
7. Persons judged inappropriate as study participants based on responses to the background survey.
8. Persons who participated in other clinical studies within 1 month prior to obtaining consent to participate in this study, or persons who plan to participate in other clinical studies after consenting to this study.
9. Persons who are breastfeeding, pregnant, or planning or hoping to become pregnant during the study period.
10. Persons otherwise judged inappropriate as study participants by the principal investigator.
Target sample size
10
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 | 09 | Month | 29 | 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 | 09 | Month | 16 | Day |
Date of IRB
| 2026 | Year | 09 | Month | 28 | Day |
Anticipated trial start date
| 2026 | Year | 10 | Month | 12 | Day |
Last follow-up date
| 2027 | 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 | 09 | Month | 29 | Day |
Last modified on
| 2026 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072229
