Tokyo, July 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000058493) titled 'Effects of consumption of the test food on cognitive function in healthy Japanese' on July 16.

Study Type: Interventional

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

Primary Sponsor: Institute - KIM's Korean Ginseng 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. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: 12 weeks Test product: Tablet containing ripened Korean red ginseng extract powder Administration: Take three tablets per day at any time during the day.

*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 not containing ripened Korean red ginseng extract powder Administration: Take three tablets per day at any time during the day.

*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 or more 4. Healthy individuals 5. Individuals who are aware of a decline in memory (e.g., difficulty finding or recalling words) 6. Individuals whose scoring of Mini Mental State Examination (MMSE) is 24 or more at Scr 7. Individuals whose validity indicator for Verbal Memory on Cognitrax is marked as "yes" at Scr 8. Individuals whose standardized score of Verbal Memory on Cognitrax is less than 90 at Scr Key exclusion criteria - Individuals who 1. under treatment or have a history of malignant tumor, heart failure, or myocardial infarction 2. have a pacemaker or an implantable cardioverter defibrillator 3. under treatment for cardiac arrhythmia, liver disorder, chronic kidney disease, cerebrovascular disorder, rheumatic disease, diabetes mellitus, dyslipidemia, hypertension, or any other chronic diseases 4. have dementia 5. have a history of mental health issues (e.g., depression disorder, attention deficit/hyperactivity disorder), reflux esophagitis, HIV, mitochondrial toxicity, long-term hepatitis C liver disease, hypercholesterolemia, chronic renal failure, valve replacement surgery, coronary artery stent, or gastric bypass surgery 6. need to take antipyretic analgesic (e.g., acetaminophen or ibuprofen) for a long term 7. take a large amount of caffeine (more than 3~4 cups a day) 8. are smokers or have not completed one year since starting to quit smoking 9. take "Foods for Specified Health Uses" or "Foods with Functional Claims" 10. take supplements or foods that may be related to improving cognitive functions (e.g., docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, or plasmalogen) 11. take blue-backed fish (e.g., sardines, mackerel, or saury) at least four times a week 12. use devices, equipment, or applications that may affect cognitive functions (e.g., brain training puzzles or brain training games) 13. take or use medicines (including herbal medicines) or supplements 14. are allergic to medicines or foods related to the test food (particularly ginseng (Korean ginseng)) 15. are pregnant, lactating, or planning to become pregnant during this study 16. 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 17. judged as ineligible to participate in this study by the physician Target Size - 60

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2025 Year 07 Month 09 Day Date of IRB - 2025 Year 07 Month 09 Day Anticipated trial start date - 2025 Year 07 Month 16 Day Last follow-up date - 2026 Year 03 Month 13 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000066874

Disclaimer: Curated by HT Syndication.