Tokyo, Nov. 11 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063582) titled 'Effects of Continuous Test Food Intake on Concentration: A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Study' on Nov. 11.

Study Type: Interventional

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

Primary Sponsor: Institute - Macromill Carenet, Inc.

Condition: Condition - None (Healthy adults) Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To investigate the effects of 12-week continuous intake of the test food on concentration, a randomized, double-blind, placebo-controlled, parallel-group trial will be conducted in healthy males and females aged 20 to under 65 years who subjectively feel a decline in concentration. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - 12-week intake of test food Interventions/Control_2 - 12-week intake of placebo food

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - 1. Healthy Japanese male and female individuals aged 20 years or older and under 65 years at the time of providing informed consent. 2. Individuals who subjectively feel a decline in concentration. 3. Individuals who have received sufficient explanation of the study, have the capacity to provide informed consent, fully understand the study, and are able to provide electronic informed consent. Key exclusion criteria - 1. Having psychiatric disorders or sleep disorders with medical treatment/medication, or severe history thereof. 2. Having chronic diseases with medical treatment/medication. 3. A history of severe cerebrovascular, cardiac, hepatic, renal, hematologic, or endocrine diseases. 4. Severe history of gastrointestinal surgery (gastrectomy, gastrointestinal suture, bowel resection; excluding simple appendectomy). 5. Regular use of drugs that affect bowel movements. 6. Suspected dementia judged by the principal investigator via subjective cognitive check. 7. Risk of allergy to the test food. 8. Difficulty completing Cognitrax. 9. Difficulty undergoing EEG. 10. Unable to discontinue fermented milk or lactic acid drinks during the study. 11. Unable to discontinue FOSHU, foods with function claims, health foods, or supplements during the study. 12. Current smokers. 13. Habitual alcohol drinkers (approx. 60 g or more alcohol per day). 14. Extremely irregular sleep/diet habits (shift/night workers) or engaged in heavy manual labor. 15. Potential major changes in living environment, diet, or exercise during the trial. 16. Women who are breastfeeding, pregnant, potentially pregnant, or planning pregnancy. 17. Current, recent (within 4 weeks prior to web screening), or scheduled participation in other clinical studies. 18. Judged ineligible by the principal investigator. Target Size - 220

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 11 Month 05 Day Date of IRB - 2026 Year 11 Month 05 Day Anticipated trial start date - 2026 Year 11 Month 11 Day Last follow-up date - 2027 Year 05 Month 05 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072752

Disclaimer: Curated by HT Syndication.