UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000061496 |
|---|---|
| Receipt number | R000070358 |
| Scientific Title | Effects of continuous intake of soy protein, agar, or BARLEYmax on intestinal microbiota and performance in athletes |
| Date of disclosure of the study information | 2026/05/08 |
| Last modified on | 2026/05/08 16:30:59 |
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Basic information
Public title
Effects of continuous intake of soy protein, agar,or BARLEYmax on intestinal microbiota and performance in athletes
Acronym
Effects of continuous intake of soy protein, agar, or BARLEYmax on intestinal microbiota and performance in athletes
Scientific Title
Effects of continuous intake of soy protein, agar, or BARLEYmax on intestinal microbiota and performance in athletes
Scientific Title:Acronym
Effects of continuous intake of soy protein, agar, or
BARLEYmax on intestinal 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
The purpose of this study is to exploratorily evaluate the effects of 8-week continuous intake of test foods (soy protein, agar, or BARLEYmax) on the intestinal environment, QOL, and performance in adult male and female athletes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Intestinal microbiota in stool at the beginning of and after the intake for 8 weeks.
Key secondary outcomes
QOL questionnaire (defecation status, etc.) and performance evaluation (various sports indicators)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake 10-15g of test food A (soy protein) once a day daily for 8 weeks.
Interventions/Control_2
Intake 2-10g of test food B (agar) once a day daily for 8 weeks.
Interventions/Control_3
Intake 6-10g of test food C (barley food) once a day daily for 8 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
| 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 study, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate.
2. Japanese men and women aged 18 to 64 at the time of informed consent.
3. Athletes who are daily engaged in sports competitions or training.
4. Persons who do not suffer from intestinal diseases (including those judged not to require immediate treatment).
Key exclusion criteria
1. Persons who may develop abdominal pain due to materials containing soy protein (TVP), agar, or BARLEYmax.
2. Persons currently diagnosed with small or large intestinal diseases (including inflammatory bowel disease (IBD) and other gastrointestinal diseases with inflammation), those who have undergone or will require resection of the small or large intestine.
3. Persons who routinely (3 or more days per week) consume materials containing soy protein (TVP), agar, or BARLEYmax, or who did so within one month before the pre-test.
4. Persons diagnosed with malignant tumors or being treated for cranial nerve, heart, kidney, thyroid diseases, or diabetes, or with a history of serious diseases such as liver disease. (Excluding those judged by the investigator to have no impact on the study, such as hypertension treatment.)
5. Persons who consume excessive alcohol (more than 60g of alcohol per day).
6. Persons at risk of developing allergies related to the test foods.
7. Persons judged inappropriate as participants based on the background survey.
8. Persons who participated in other clinical studies within one month before the start of this study or plan to participate in other studies after consenting.
9. Persons who are pregnant, breastfeeding, or planning to become pregnant during the study period.
10. Others judged as inappropriate by the principal investigator.
Target sample size
300
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., BUBBLE STAR Co., Ltd., Ina Food Industry 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 | 05 | Month | 08 | 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 | 04 | Month | 23 | Day |
Date of IRB
| 2026 | Year | 05 | Month | 07 | Day |
Anticipated trial start date
| 2026 | Year | 05 | Month | 11 | Day |
Last follow-up date
| 2026 | 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
| 2026 | Year | 05 | Month | 08 | Day |
Last modified on
| 2026 | Year | 05 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000070358
