Tokyo, Aug. 22 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058858) titled 'A study to evaluate the effects of test food consumption on the improvement of health functions (brain function)' on Aug. 21.

Study Type: Interventional

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

Primary Sponsor: Institute - Bizen Chemical Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of test food consumption on the improvement of cognitive function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Tablet containing high-dose S-allylcysteine (SAC) extract powder Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not eat breakfast, take tablets in the morning.

*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day. Interventions/Control_2 - Duration: 12 weeks Test product: Tablet containing fermented SAC extract powder Administration: Take six tablets per day with water within 30 minutes after breakfast. If you do not eat breakfast, take tablets in the morning.

*If you forget to take the test food, take it as soon as you remember. The daily dose should be taken within the day and not carried over to the next day.

Eligibility: Age-lower limit - 45 years-old

Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Individuals aged 45 or older and younger than 70 4. Healthy individuals 5. Individuals who are aware of a decline in memory 6. Individuals whose Mini Mental State Examination (MMSE) is 24 or higher at screening 7. Individuals whose validity indicators for both the Verbal Memory and Visual Memory Tests on Cognitrax are marked as "Yes" at screening 8. Individuals whose standardized score in Verbal Memory of Cognitrax is less than 100 at screening Key exclusion criteria - Individuals who 1. are under treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are under treatment for any of the following chronic diseases: cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 5. take or use medicines (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product (particularly, onion, garlic chives, or garlic) 7. are pregnant, lactating, or planning to become pregnant during this study 8. have been enrolled in other clinical studies within the last 28 days before the agreement to participate in this study or plan to participate in another study during this study 9. have dementia 10. have a history of mental disorder (e.g., depression or attention-deficit/hyperactivity disorder) 11. regularly consume foods with rich procyanidins (e.g., apples, black soybeans, cacao) 12. regularly consume foods or supplements that may affect cognitive function (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, plasmalogen) 13. consume blue-backed fish at least four times a week (e.g., sardines, mackerel, saury) 14. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 15. have irregular sleeping time or habit due to work (e.g., late-night shift) 16. are smokers or have quit smoking within the last three months before the agreement to participate in this study 17. consume alcohol excessively (>=60 g/day) 18. have irregular lifestyles (e.g., diet, exercise, sleep) 19. are judged as ineligible to participate in this study by the physician Target Size - 90

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 25 Day Date of IRB - 2025 Year 07 Month 25 Day Anticipated trial start date - 2025 Year 08 Month 21 Day Last follow-up date - 2026 Year 02 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067308

Disclaimer: Curated by HT Syndication.