Clinical Trial: Verification of conditions for the continuation of health behaviors in a lifestyle-review model: transition from guided support to self-management using AI support combined with a health-maintenance support food (Japan)

Tokyo, Aug. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062400) titled 'Verification of conditions for the continuation of health behaviors in a lifestyle-review model: transition from guided support to self-management using AI support combined with a health-maintenance support food' 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 - Healthy Aging Labs. LLC

Condition: Condition - Not a specific disease. Community-dwelling healthy adults aged 40 years or older (including those in a pre-disease [mibyou] state) who are interested in lifestyle review. Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To identify the conditions under which health awareness and health behaviors are maintained after the end of guided support (self-management phase) in a lifestyle-review model, taking into account changes during the guided-support phase. Focusing on six foundational lifestyle elements (sleep, diet, bowel movements, daytime activity, life rhythm, and social engagement), the study examines the conditions for the transition from guided support to self-management, and whether an AI-centered graduation-type (self-management) lifestyle-review model can function as a sustainable health-support model while reducing dependence on human support. This study is not designed to evaluate the efficacy of the supplement alone or its disease-improving effects. The supplement is positioned as a supportive component of lifestyle review, and its association with subjective bodily sensations, health awareness, and continuation of health behaviors is examined exploratorily. Basic objectives2 - Others

Intervention: Interventions/Control_1 - A lifestyle-review model (Kushiro Model) is delivered over 20 weeks. Guided-support phase (W1-W8): weekly smartphone-based self-check (items Q1-Q10, each 0-3), weekly AI-assisted reflection support (organized according to preset rules; no medical advice, diagnosis, or treatment instruction is provided), and monthly reflection support by a human supporter. Self-management phase (W9-W20): individual support by the human supporter ends, while weekly self-check and weekly/monthly AI reflection support continue. As a supportive component, a food-derived health supplement (main components: EubioQuercetin [a food-derived material containing rutin, L-arginine, and vitamin C], Shirai Panax notoginseng powder, etc.) is provided free of charge during the study (guide: 2 capsules twice daily, adjustable at the participant's discretion). The supplement is a supportive component of lifestyle review and is not the object of evaluation itself.

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Adults aged 40 or older residing in Kushiro City, Hokkaido, or surrounding areas. 2. Interested in health maintenance or lifestyle review. 3. Able to review existing health-checkup results (no new blood sampling). 4. Able to complete a weekly self-check via smartphone, etc. 5. Understand the study and provide written informed consent. 6. Judged capable of self-management regarding lifestyle review and supplement use during the study. Key exclusion criteria - 1. Under treatment for a disease at a medical institution such that participation is judged difficult. 2. Restricted by an attending physician regarding diet, exercise, lifestyle change, or intake of health supplements. 3. History of clear intolerance or adverse reaction to the food-derived components used (rutin, L-arginine, vitamin C, Panax notoginseng, etc.). 4. Judged by the PI as having difficulty understanding the study or maintaining continuous entry due to cognitive/psychological or other reasons. 5. Judged inappropriate for participation by the PI. Target Size - 80

Recruitment Status: Recruitment status - Preinitiation 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 08 Month 05 Day Last follow-up date - 2027 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071414

Disclaimer: Curated by HT Syndication.