Tokyo, Oct. 2 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063129) titled 'A Three-Year Observational Study on the Relationship Between Tsuruoka Food Culture, Gut Health, and Overall Health' on Oct. 1.

Study Type: Observational

Primary Sponsor: Institute - Keio University

Condition: Condition - Dietary habits, gut environment, and physical and psychological health status Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The primary objective of this study is to longitudinally investigate, over a three-year period, the association between habitual dietary diversity and the diversity and composition of the gut microbiota among adults residing in the Shonai region, with a particular focus on the food culture of Tsuruoka City, Yamagata Prefecture, a UNESCO Creative City of Gastronomy. This regional food culture includes traditional local crops, fermented foods, and seasonal dietary practices. In addition, this study will collect multilayered data on dietary habits, gut microbiota, fecal metabolites, bowel habits, body composition, health-related quality of life (QOL), lifestyle behaviors, physical activity, and sleep, and will exploratorily investigate the associations between regional food culture and lifestyle factors, the gut environment, and physical and psychological health indicators. Basic objectives2 - Others

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Participants must meet all of the following criteria: 1. Adults aged 18 years or older who reside in the Shonai region of Yamagata Prefecture at the time informed consent is obtained 2. Individuals who are registered as gut microbiota donors at the Tsuruoka Kenben Room, or who have previously been registered as donors or undergone screening as potential donor candidates 3. Individuals who are willing to participate in three years of continuous follow-up, including four site visits per year and provision of study data 4. Individuals who have received sufficient explanation of the study based on the informed consent document and who voluntarily provide written informed consent to participate Key exclusion criteria - Individuals meeting any of the following criteria will be excluded: 1. Individuals with a history of or currently undergoing treatment for serious gastrointestinal diseases, including inflammatory bowel disease, colorectal cancer, or status after extensive gastrointestinal resection 2. Individuals whom the principal investigator determines would have difficulty complying with the study protocol, including completion of self-administered questionnaires, regular study visits, or sample collection, due to psychiatric disorders, cognitive impairment, serious comorbidities, or other conditions 3. Individuals whom the principal investigator or study investigators otherwise determine to be unsuitable for safe and appropriate participation in the study Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 25 Day Anticipated trial start date - 2026 Year 09 Month 30 Day Last follow-up date - 2030 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072261

Disclaimer: Curated by HT Syndication.