Tokyo, May 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061496) titled 'Effects of continuous intake of soy protein, agar,or BARLEYmax on intestinal microbiota and performance in athletes' on May 8.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -no one is blinded Control - Active

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

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

Objective: 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

Intervention: 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.

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 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 Size - 300

Recruitment Status: 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

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000070358

Disclaimer: Curated by HT Syndication.