Tokyo, Feb. 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060771) titled 'Study on the Effects of Test Food Intake on Cognitive Function --A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group Comparative Trial--' on Feb. 27.

Study Type: Interventional

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

Primary Sponsor: Institute - TES Holdings Co., Ltd.

Condition: Condition - No Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - The purpose of this study is to examine the effects of consuming the test food on cognitive function. Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral ingestion of a test food (2 capsules in a day; 16 weeks). Interventions/Control_2 - Oral ingestion of a placebo food (2 capsules in a day; 16 weeks).

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1) Healthy men and women aged 40 to 59 at the time of obtaining consent to participate in the trial. 2) Individuals with normal cognitive function. 3) Individuals who experience stress or fatigue due to work or household duties and perceive a decline in cognitive function (information processing ability, attention, memory, etc.). 4) Individuals with a work habit of five or more days per week. 5) Individuals who have received sufficient explanation regarding the purpose and content of this trial, possess the capacity to consent, voluntarily volunteer to participate after fully understanding, and can provide written consent to participate in this trial. 6) Individuals who can attend the designated examination date and undergo the examination. 7) Individuals deemed suitable for participation in this trial by the principal investigator. Key exclusion criteria - Individuals 1) currently suffering from any disease and undergoing treatment, or individuals using pharmaceuticals. 2) receiving treatment or medication due to dementia, mental illness, or cerebrovascular disease. 3) diagnosed with cerebral infarction, cerebrovascular disease, arteriosclerosis, or circulatory system disease. 4) with a history of serious past or current medical conditions involving the liver, kidneys, heart, lungs, blood, digestive tract, or mental disorders. 5) exhibiting symptoms of severe anemia. 6) who have taken or applied medications for disease treatment within the past month. 7) with potential cognitive impairment. 8) Individuals unable to respond to the study assessments, including: a) with difficulty distinguishing colors. b) with uncorrected or poorly corrected vision impairment. c) unable to understand the test due to hearing impairment. d) with limited ability to communicate in Japanese. e) unable to recognize Arabic numerals. 9) with a BMI of 30.0 kg/m2 or higher. 10) with potential allergies to test food ingredients or other foods/medications. 11) who used cognitive function-related foods or supplements within the past 3 months. 12) who used or plan to use supplements containing test food or result-affecting ingredients within 3 months. 13) with a habit of excessive consumption of beverages high in caffeine. 14) exceeding daily alcohol limits (40 g men, 20 g women). 15) with irregular daily routines. 16) Night shift workers. 17) who may alter their daily routines during the study period. 18) who are pregnant, breastfeeding, or may become pregnant during the trial period. 19) another trial or within the past 3 months. 20) with ties to health/functional food companies. 21) Other individuals deemed ineligible for this trial by the principal investigator. Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 01 Month 28 Day Date of IRB - 2026 Year 01 Month 29 Day Anticipated trial start date - 2026 Year 03 Month 21 Day Last follow-up date - 2026 Year 08 Month 02 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069233

Disclaimer: Curated by HT Syndication.