Tokyo, Oct. 26 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059528) titled 'Effects of consumption of the test food on decision fatigue in healthy adults' on Oct. 24.

Study Type: Interventional

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

Primary Sponsor: Institute - Toyo Sugar Refining Co., Ltd.

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

Objective: Narrative objectives1 - To verify the effects of consumption of the test food on decision fatigue in healthy adults. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Duration: Eight weeks Test product: Modified polyphenol Interventions/Control_2 - Duration: Eight weeks Test product: Placebo

Eligibility: Age-lower limit - 18 years-old = 15 and responses of >= 3 on at least five items of the DFS at screening

7. Individuals who are judged as eligible to participate in this study by the physician according to the results of the Beck Depression Inventory 2nd Edition (BDI-II) at screening

8. Individuals whose Mini-Mental State Examination (MMSE) score is >= 24 at screening

9. Individuals whose validity indicator for Reaction Time on Cognitrax is "Yes" at screening

10. Individuals whose standardized score of Reaction Time on Cognitrax is = 50 mm at screening Key exclusion criteria - 1. Individuals who are undergoing medical treatment or have a medical history of malignant tumor, heart failure, or myocardial infarction

2. Individuals who have a pacemaker or an implantable cardioverter defibrillator (ICD)

3. Individuals who 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. Individuals who have dementia or a history of psychiatric disorders, such as depression disorder or attention-deficit/hyperactivity disorder (ADHD)

5. Individuals who are taking "Foods for Specified Health Uses" or "Foods with Functional Claims"

6. Individuals who are taking or using medicines (including herbal medicines) or supplements

7. Individuals who regularly consume foods or supplements that may affect cognitive function, such as docosahexaenoic acid (DHA) or eicosapentaenoic acid (EPA)

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

9. Individuals who use tools, devices, or applications that may affect cognitive function

10. Individuals who are allergic to medicines or foods related to the test product

11. Individuals with irregular sleeping duration or patterns due to night shifts or similar work, or with irregular lifestyles

12. Individuals who currently smoke or began smoking cessation within three months before providing informed consent

13. Individuals who habitually drink >= 60 g/day of alcohol

14. Individuals who are pregnant, lactating, or planning to become pregnant during this study

15. Individuals who 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

16. Individuals who are 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 10 Month 08 Day Date of IRB - 2025 Year 10 Month 08 Day Anticipated trial start date - 2025 Year 10 Month 24 Day Last follow-up date - 2026 Year 06 Month 16 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000068094

Disclaimer: Curated by HT Syndication.