Tokyo, July 15 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062228) titled 'Effects of Rice Koji consumption on gut microbiota and brain health (cognitive function), and its association with a Japanese diet' on July 14.

Study Type: Interventional

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

Primary Sponsor: Institute - Oita University

Condition: Condition - dementia Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - While the Japanese-style diet is recognized for its excellent nutritional balance and its contribution to longevity and the prevention of lifestyle-related diseases, its preservation has become challenging in recent years due to factors such as the Westernization of diets and a shift away from traditional Japanese cuisine.

Amidst this context, research focusing on the relationship between the Japanese diet, gut microbiota, and cognitive function is underway; studies have reported that frequent consumption of a Japanese diet leads to an increase in butyrate-producing bacteria in the gut. Butyrate is a type of short-chain fatty acid known for its antidepressant and cognitive-enhancing properties. Research conducted by the National Center for Geriatrics and Gerontology has also reported that individuals without dementia tend to have higher "Japanese diet scores" than those with dementia. Fermented foods -- an essential component of the Japanese diet -- have also been the subject of recent research into their various health benefits; for instance, ergothioneine, found in rice koji, has demonstrated antioxidant properties in mouse experiments and has been linked to antidepressant effects and improvements in cognitive function.

This study aims to clarify the relationship between adherence to a Japanese-style diet and gut microbiota composition, the effects of rice koji consumption on gut microbiota and cognitive function, and how the baseline level of adherence to a Japanese-style diet influences these outcomes Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Consuming one bottle (118 g) of rice-koji amazake daily for 12 weeks. Interventions/Control_2 - Consuming one bottle (118 g) of a placebo beverage daily for 12 weeks.

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - Healthy adult men and women aged 40 or older Key exclusion criteria - -Individuals currently receiving treatment or medication for gastrointestinal, inflammatory, or metabolic diseases diagnosed by a physician (e.g., gastrointestinal diseases such as inflammatory bowel disease, irritable bowel syndrome, or celiac disease; diabetes; dyslipidemia; chronic liver disease; chronic kidney disease) -Individuals with a history of surgery for gastrointestinal diseases, such as gastrectomy or intestinal resection -Individuals currently receiving treatment or medication for dementia, Alzheimer's disease, psychiatric disorders, or cerebrovascular disease -Individuals who have used or are currently using the following medications within the past 3 months: Antibiotics, steroids, immunosuppressants, or antacids (e.g., proton pump inhibitors, H2 blockers) -Individuals who habitually and frequently consume probiotics, prebiotics, or supplements that may affect the gut microbiota -Individuals who are pregnant or breastfeeding -Individuals planning significant changes to their dietary or lifestyle habits (e.g., extreme dietary restrictions, weight loss programs) during the study period -Individuals currently participating in another clinical trial or who have participated in one within the past 4 weeks -Individuals otherwise deemed unsuitable for participation in this study by the principal investigator Target Size - 60

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 07 Month 14 Day Date of IRB - 2026 Year 06 Month 10 Day Anticipated trial start date - 2026 Year 07 Month 21 Day Last follow-up date - 2027 Year 11 Month 30 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000071205

Disclaimer: Curated by HT Syndication.