Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062399) titled 'Functional evaluation of mycoproteins (Gut microbiota)' on July 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Agro Ludens Inc.

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

Objective: Narrative objectives1 - Exploratory evaluation of the effects of 6-week mycoprotein consumption on the gut environment. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intake of test food for 6 weeks

Eligibility: Age-lower limit - 30 years-old

Gender - Male and Female Key inclusion criteria - 1.Subjects aged 30 to 60 at the time of obtaining consent 2.Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent 3.Subjects who have not taken any foods for specified health uses, functional foods, dietary supplements, that may affect defecation, or who can maintain the same type and frequency of intake of these products they have been taking up until that point during the study period Key exclusion criteria - 1.Subjects with serious cardiovascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders (Including those taking medications for the treatment or management of conditions such as diabetes, dyslipidemia, or hypertension) 2.Subjects receiving treatment for a gastrointestinal disease currently or those who have had gastrointestinal surgery 3.Subjects with an allergy to the test food 4.Subjects who are suffering from or have a history of a disease that may affect defecation 5.Subjects who take regularly pharmaceuticals or quasi-drugs having the efficacy for microbiome such as intestinal regulator 6.Subjects who have used antibiotics within the past month, or who plan to use them during the study period 7.Subjects who plan to make significant changes to their lifestyle (e.g., diet, sleep, exercise) during the study period 8.Female subjects who are pregnant or lactating, or intending to become pregnant during the study 9.Subjects who took part in another study within 3 months prior to the start of the present study or who are currently taking part in another study 10. Subjects deemed unsuitable by the investigator Target Size - 30

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 07 Month 23 Day Date of IRB - 2026 Year 07 Month 23 Day Anticipated trial start date - 2026 Year 07 Month 31 Day Last follow-up date - 2026 Year 10 Month 09 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071416

Disclaimer: Curated by HT Syndication.