Tokyo, Jan. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060216) titled 'The effects of cognitive training on the intestinal environment' on Jan. 1.

Study Type: Interventional

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

Primary Sponsor: Institute - Kyodo Milk Industry Co., Ltd.

Condition: Condition - Healthy adults Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To evaluate the influence of brain activation induced by cognitive training on the gut environment during middle age Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Face Name Associative Memory Exam

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese men and women aged between 40 and 60 years. 2. Individuals who do not regularly engage in brain training; however, individuals who have not engaged in brain training for at least six months are eligible to participate. 3. Individuals who voluntarily agreed to participate in the study after receiving ufficient explanation and providing written informed consent Key exclusion criteria - 1. Individuals who currently require medication or regular medical visits 2. Individuals undergoing dietary or exercise therapy under medical supervision. 3. Individuals with current or past history of serious diseases 4. Individuals who regularly consume over-the-counter medications, quasi-drugs, dietary supplements, or foods with health claims such as Foods for Specified Health Uses (FOSHU) or Foods with Functional Claims (FFC); however, those who are able to discontinue such use after giving consent may be eligible to participate. 5. Individuals with drug or food allergies. 6. Individuals who have donated blood components or 200 mL of whole blood within one month prior to the start of the study. 7. Individuals who have donated 400 mL of whole blood within four months prior to the start of the study. Individuals who have participated in other clinical trials or clinical studies within one month prior to obtaining informed consent, are currently participating, or plan to participate during the study period. 9. Women who are currently pregnant or breastfeeding, or who plan to become pregnant during the study period." 10. Individuals with habitual excessive alcohol consumption (>=60 grams of ethanol per day). 11. Individuals with irregular lifestyles, including those with highly irregular eating habits, shift work, or night shifts 12. Individuals with constipation or a tendency toward constipation who are deemed unable to submit stool samples for this trial 13. Individuals who regularly engage in brain training, including free or paid brain training apps, memory games, and brain training drills from books and magazines; however, individuals who have not engaged in brain training for at least six months are eligible to participate. 14. Individuals judged by the principal medical doctor to be inappropriate for participation in the study. Target Size - 15

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 21 Day Date of IRB - 2025 Year 11 Month 21 Day Anticipated trial start date - 2025 Year 11 Month 22 Day Last follow-up date - 2026 Year 03 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068755

Disclaimer: Curated by HT Syndication.