Tokyo, Oct. 1 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063120) titled 'Verification study of the effects of test food consumption on cognitive function in healthy Japanese' on Sept. 30.

Study Type: Interventional

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

Primary Sponsor: Institute - Claudia 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: Liquid form containing GPC Administration: Consume two capsules once with water after dinner or before sleep.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following day. Interventions/Control_2 - Duration: 12 weeks Test product: Liquid form not containing GPC Administration: Consume two capsules once with water after dinner or before sleep.

*If a dose is missed, it should be consumed as soon as remembered. The daily dose should be consumed within the same day and should not be carried over to the following 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 whose scoring of Mini Mental State Examination (MMSE) is 24 or more at screening (Scr)

6. Individuals who have a "yes" in the validity indicator of Cognitrax on both verbal memory and visual memory at Scr

7. Individuals whose standardized score in verbal memory measured using Cognitrax is less than 100 at Scr Key exclusion criteria - Individuals (who / whose) 1. are receiving treatment for or have a history of malignant tumors, heart failure, or myocardial infarction

2. have an implanted pacemaker or 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. consume 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 medications or foods related to the test product

7. have dementia

8. have mental health issues such as depression disorder, attention deficit/hyperactivity disorder (ADHD), or other issues

9. regularly consume foods with rich procyanidins (such as apple, black soybean, or cacao)

10. usually take supplements or foods that may be related to improving cognitive functions, such as docosahexaenoic acid, eicosapentaenoic acid, ginkgo leaf extract, tocotrienol, astaxanthin, gamma-aminobutyric acid, phosphatidylserine, and plasmalogen

11. take blue-backed fish such as sardines, mackerel, and saury at least four times a week

12. use devices, equipment, and applications that may affect cognitive functions (e.g., brain training puzzles, brain training games)

13. have irregular sleeping time or habit due to work such as a late-night shift

14. currently smoke or began smoking cessation within three months before providing informed consent

15. habitually drink more than 60 g/day of alcohol

16. are pregnant, lactating, or planning pregnancy during this study

17. have participated in other clinical studies within 28 days before informed consent, or plan to participate in another study during this study

18. are deemed unsuitable for participation in this study by the principal investigator Target Size - 56

Recruitment Status: Recruitment status - Open public recruiting Date of protocol fixation - 2026 Year 09 Month 09 Day Date of IRB - 2026 Year 09 Month 09 Day Anticipated trial start date - 2026 Year 09 Month 30 Day Last follow-up date - 2027 Year 04 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072255

Disclaimer: Curated by HT Syndication.