Tokyo, Feb. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060616) titled 'Comparative study on the effects of Echizen cheese produced using Buckwheat-Derived lactic acid bacteria in Fukui on sleep quality and gut microbiota' on Feb. 9.

Study Type: Interventional

Study Design: Basic Design - Cross-over Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Fukui Prefectural University

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

Objective: Narrative objectives1 - The purpose of this study is to verify the effects of consuming natural cheese containing Fukui Prefecture buckwheat-derived lactic acid bacteria on human sleep quality and gut microbiota. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Each cycle lasts 20 days. During the first 6 days, participants complete a sleep questionnaire and collect stool samples. After consuming Echizen cheese for the next 14 days, they complete another sleep questionnaire and collect stool samples. Following a 14-day washout period, the second cycle involves the same intervention using placebo cheese. Interventions/Control_2 - Each cycle lasts 20 days. During the first 6 days, participants complete a sleep questionnaire and collect stool samples. After consuming placebo cheese for the next 14 days, they complete another sleep questionnaire and collect stool samples. Following a 14-day washout period, the second cycle involves the same intervention using Echizen cheese.

Eligibility: Age-lower limit - 18 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Residents of the Hokuriku region aged 18 or older Individuals scoring 4 or higher on the Athens Insomnia Scale Individuals who understand the content of this study and have provided written consent Key exclusion criteria - Individuals with dairy allergies Individuals with digestive disorders such as inflammatory bowel disease or irritable bowel syndrome Individuals who regularly take laxatives Individuals with dietary restrictions for medical or religious reasons Individuals who regularly take sleeping pills or sleep aids, or those with sleep disorders such as sleep apnea Target Size - 30

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 12 Month 08 Day Date of IRB - 2025 Year 12 Month 08 Day Anticipated trial start date - 2026 Year 02 Month 09 Day Last follow-up date - 2026 Year 06 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068798

Disclaimer: Curated by HT Syndication.