Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062157) titled 'A Comprehensive Study of Gut Microbiota and Mental and Physical Health Following Lifestyle Guidance and Exercise Intervention' on Aug. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - bacterico, Inc.

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

Objective: Narrative objectives1 - To examine the effect of lifestyle guidance on gut microbiota composition in healthy adults, and to explore the association between changes in gut microbiota and brain measures. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Intervention group: 8-week dietitian-led lifestyle guidance and a mental health seminar. Interventions/Control_2 - Wearing a digital device (Fitbit or MITSUFUJI03) at all times except during bathing to record ambient temperature, step count, heart rate, and pulse wave. Sending a notification every Monday to promote walking "7,000 steps or more per day". The intervention period is 8 weeks.

Eligibility: Age-lower limit - 18 years-old

Gender - Male and Female Key inclusion criteria - 1. Men and women aged 18 to under 80 years at the time of consent. 2. Those who have received sufficient explanation about the study, understand its contents, and can provide personal consent. Key exclusion criteria - 1. Those participating in other clinical trials for pharmaceuticals or health foods within 4 weeks. 2. Others judged inappropriate for participation in this study by the principal investigator. Target Size - 90

Recruitment Status: Recruitment status - Completed Date of protocol fixation - 2025 Year 03 Month 27 Day Date of IRB - 2025 Year 03 Month 21 Day Anticipated trial start date - 2025 Year 04 Month 01 Day Last follow-up date - 2025 Year 10 Month 03 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071049

Disclaimer: Curated by HT Syndication.