Tokyo, Aug. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058735) titled 'Effects of consumption of the test product on cognitive function in healthy Japanese: a randomized, placebo-controlled, double-blind, parallel-group comparison study' on Aug. 8.

Study Type: Interventional

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

Primary Sponsor: Institute - UCC UESHIMA COFFEE CO., LTD.

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

Objective: Narrative objectives1 - To verify the effects of consumption of procyanidins B1 and B3 contained in coffee cherry pulp extract on the maintenance and improvement of cognitive function in Japanese aged 40 years or older, a study was conducted based on the results of the previous study (UMIN000051275). Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Capsule containing coffee cherry pulp extract Administration: Take one capsule per day with water.

*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: Capsule containing dextrin powder Administration: Take one capsule per day with water.

*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 - 40 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - 1. Japanese 2. Men or women 3. Individuals aged 40 years or older 4. Healthy individuals 5. Individuals whose MMSE score is 24 or higher at screening 6. Individuals whose validity indicators for both the Verbal Memory and Visual Memory on Cognitrax are marked as "Yes" at screening 7. Individuals whose standard score in Verbal Memory of Cognitrax is 89 or lower at screening Key exclusion criteria - Individuals who 1. are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. are currently 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 medications (including herbal medicines) or supplements 6. are allergic to medicines or foods related to the test product 7. have dementia 8. have a history of mental disorder such as depression or attention-deficit/hyperactivity disorder (ADHD) 9. take foods or supplements that may affect cognitive function, such as docosahexaenoic acid (DHA), eicosapentaenoic acid (EPA), ginkgo leaf extract, tocotrienols, astaxanthin, gamma-aminobutyric acid (GABA), phosphatidylserine, and plasmalogen 10. take blue-backed fish such as sardines, mackerel, and saury at least four times a week 11. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 12. have irregular sleeping time or habit due to work, such as a late-night shift 13. have a large variation in their daily smoking amount 14. have a large variation in their daily alcohol consumption 15. have irregular lifestyles (such as diet, exercise, and sleep) 16. have caffeine sensitivity 17. take beverages with rich caffeine, such as coffee or energy drink in daily 18. are pregnant, lactating, or planning to become pregnant during this study 19. 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 20. are judged as ineligible to participate in this study by the physician Target Size - 150

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 08 Month 06 Day Date of IRB - 2025 Year 08 Month 06 Day Anticipated trial start date - 2025 Year 08 Month 09 Day Last follow-up date - 2026 Year 05 Month 04 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067159

Disclaimer: Curated by HT Syndication.