Tokyo, Sept. 30 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063098) titled 'Effects of continuous intake of soy protein on gut microbiota and performance in athletes' on Sept. 29.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

Primary Sponsor: Institute - Biosis Lab Co., Ltd.

Condition: Condition - Healthy Adults Classification by malignancy - Others Genomic information - NO

Objective: 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

Intervention: Interventions/Control_1 - Intake of approximately 20 grams of test food (processed soy protein food) once daily for 4 weeks

Eligibility: Age-lower limit - 18 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 Size - 10

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072229

Disclaimer: Curated by HT Syndication.