Tokyo, March 20 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060965) titled 'A Study on Exercise-Induced Changes in the Gut Microbiota and Metabolism' on March 20.

Study Type: Interventional

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

Primary Sponsor: Institute - Nippon Medical School

Condition: Condition - none Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate changes in gut microbiota and metabolism-related factors between periods with and without exercise. Basic objectives2 - Others

Intervention: Interventions/Control_1 - During the exercise period (4 weeks), participants will be required to perform physical activity of 4 METs or more for 30 minutes or more per session, totaling 180 minutes or more per week, with no more than one consecutive day without exercise. In addition, structured exercise (non-lifestyle physical activity) must total 12 MET-hours or more per week, and these conditions will be maintained for at least 4 weeks.

During the non-exercise period (4 weeks), participants will refrain from regular structured exercise for at least 4 weeks, and structured exercise will be limited to 4 MET-hours or less per week.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Individuals aged 18 years or older who have no underlying medical conditions or regular medications, are able to perform exercise, and have provided written informed consent after receiving an explanation of the study. Key exclusion criteria - 1. Individuals with chronic medical conditions requiring pharmacological treatment. 2. Individuals who are unable to perform exercise. 3. Individuals deemed unsuitable for participation in this study by the principal investigator or co-investigators. Target Size - 15

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2024 Year 10 Month 01 Day Date of IRB - 2024 Year 11 Month 13 Day Anticipated trial start date - 2025 Year 01 Month 10 Day Last follow-up date - 2029 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069662

Disclaimer: Curated by HT Syndication.