Tokyo, Dec. 3 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059943) titled 'Effects of consumption of the test food on cognitive function' on Dec. 2.

Study Type: Interventional

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

Primary Sponsor: Institute - Euglena Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on cognitive function in healthy Japanese aged 40 years or older. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Test food Administration: Three capsules/pack/day Interventions/Control_2 - Duration: 12 weeks Test product: Placebo food Administration: Three capsules/pack/day

Eligibility: Age-lower limit - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Participants aged 40 years or older 4. Healthy participants 5. Participants whose Mini-Mental State Examination (MMSE) score is 24 or higher at screening 6. Participants who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at screening 7. Participants who meet inclusion criteria 1-6 and have a low standardized score for Verbal Memory on Cognitrax at screening Key exclusion criteria - Participants who 1. are undergoing treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are undergoing 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. are taking Foods for Specified Health Uses or Foods with Functional Claims 5. are taking or using medicines (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. have dementia 8. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder, or other issues 9. are taking foods or supplements that may affect cognitive function, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogens 10. are taking blue-backed fish such as sardines, mackerel, or saury at least four times a week 11. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games) 12. currently smoke or have quit smoking within one year prior to providing consent for this study 13. drink alcoholic beverages excessively 14. are on a diet or engage in strenuous exercise for the purpose of physical strengthening 15. have an irregular lifestyle due to shift work or other reasons 16. are taking anticoagulants such as warfarin 17. are pregnant, lactating, or planning to become pregnant during this study 18. 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 19. are judged as ineligible to participate in this study by the physician Target Size - 100

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 11 Month 26 Day Date of IRB - 2025 Year 11 Month 26 Day Anticipated trial start date - 2025 Year 12 Month 02 Day Last follow-up date - 2026 Year 06 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068545

Disclaimer: Curated by HT Syndication.