Tokyo, Jan. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060365) titled 'The effect of soy TVP consumption on the gut microbiota' on Jan. 15.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Open -but assessor(s) are blinded Control - No treatment

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

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

Objective: Narrative objectives1 - The objective of this study is to exploratively evaluate the impact of continuous four-week consumption of soy TVP on the gut microbiota and quality of life (QOL) in healthy adult men and women. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Participants will consume the test food (15g) for four weeks without specified timing or frequency Interventions/Control_2 - Participants will maintain their normal lifestyle without consuming the test food

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 research, have the capacity to consent, applied with free will with sufficient understanding, and agreed to participate 2.Persons who are Japanese citizens, aged 18 or older and under 65 at the time of consent 3.Persons who do not have intestinal diseases (including those who are judged not to require immediate treatment) Key exclusion criteria - 1.Persons who may experience abdominal pain when eating foods containing soy TVP 2.Persons who have a current diagnosis of small or large intestinal disorders (including inflammatory gastrointestinal diseases such as IBD), a history of small or large bowel resection, or a future requirement for such surgical intervention. 3.Person who regularly consumes material containing soy TVP (three or more days per week) or has regularly consumed it within one month prior to the pre-screening examination. 4.Persons who have been diagnosed with malignant tumors, are currently receiving treatment for cranial nerve disorders, heart disease, kidney disease, diabetes, or thyroid dysfunction, or have a history of other serious illnesses, excluding illnesses like hypertension, which principal investigator determined will not affect the evaluation of the research 5.Persons who drink a large amount of alcohol (60 g or more of alcohol per day: approximately 1500 mL of beer, 540 mL of wine, 3 cups of sake, or 180 mL of double-sized whiskey) 6.Persons who are at risk of developing allergies related to the test foods 7.Persons who are judged unsuitable as research subjects based on their responses to a background survey 8.Persons who have participated in other research during one month prior to the start of this research, or plan to participate in other research after consenting to this research. 9.Persons who are breastfeeding, pregnant, or have plans to become pregnant during the study period 10.Persons who are judged to be ineligible by the principal investigator Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 12 Month 22 Day Date of IRB - 2026 Year 01 Month 15 Day Anticipated trial start date - 2026 Year 01 Month 15 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069057

Disclaimer: Curated by HT Syndication.