Healthy Adults
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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).
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intestinal microbiota in stool at the beginning of and after the intake for 8 weeks. | — |
Secondary
| Measure | Time frame |
|---|---|
| QOL questionnaire (defecation status, etc.) and performance evaluation (various sports indicators) | — |
Countries
Japan
Contacts
BIOSIS Lab. Co., Ltd. CEO