Tokyo, Oct. 18 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000063299) titled 'An Investigation of the Effects of Test Food Consumption on Cognitive Function -- An Open-Label Pre- and Post-Consumption Comparison Study --' on Oct. 18.

Study Type: Interventional

Study Design: Basic Design - Single arm Randomization - Non-randomized Blinding - Open -no one is blinded Control - Uncontrolled

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 investigate the effects of 8 weeks of continuous consumption of the test food on cognitive function and to conduct an exploratory analysis comparing these results with those of previous studies. Basic objectives2 - Safety

Intervention: Interventions/Control_1 - Oral intake of the test food (4 tablets in a day; 8 weeks).

Eligibility: Age-lower limit - 20 years-old

Gender - Male and Female Key inclusion criteria - This study is open to individuals who meet either criterion 1) or 2) below and satisfy all of criteria 3) through 6).

1) Participants in a previous study who have provided written informed consent, based on their own free will, for the secondary use of various data obtained from that study in this study. 2) Men and women between 20 and 89 years of age at the time of obtaining consent to participate in the study. 3) Individuals who are healthy and have no chronic physical disease including skin disease. 4) Individuals who have been fully informed of the purpose and content of the study, have the capacity to consent, understand the study well, voluntarily volunteer to participate, and are able to consent to participation in the study in writing. 5) Individuals who can come to the designated venue for this study and be inspected. 6) Individuals judged appropriate for the study by the principal. Key exclusion criteria - 1) Individuals with chronic diseases and individuals undergoing treatment for any disease. 2) Individuals with a history or current history of chronic fatigue syndrome, psychiatric disorders, sleep disorders, hypertension, diabetes, dyslipidemia or serious illness. 3) Individuals with a history of serious or current illness in the liver, kidney, heart, lungs, blood, or gastrointestinal tract. 4) Individuals with serious anemia. 5) Individuals who used a drug to treat a disease in the past 1 month. 6) Individuals whose BMI is over 30 kg/m2. 7) Individuals who may develop allergic symptoms to any of the ingredients in the test food, or who may develop allergic symptoms to any other food or drug. 8) Individuals who are currently, or have been within the past 3 months, habitual consumers of food for specified health uses, functional foods, health foods, supplements, etc., or who plan to consume such foods during the study period. 9) Individuals whose daily alcohol consumption exceeds 40 g/day for men and 20 g/day for women on a weekly average of pure alcohol equivalent. 10) Individuals who are a smoker. 11) Individuals who work late night or shift work, or have irregular lifestyle habits. 12) Individuals with possible changes of life style during the test period. 13) Individuals with a blood draw of 200 mL within 1 month of the start of this study or 400 mL or more within 3 months of the start of this study. 14) Individuals who are currently participating in another human clinical trial or who have not yet completed 3 months of participation in another human clinical trial. 15) Individuals who are pregnant, lactating or can become pregnant and intend to become pregnant during the study period. 16) Individuals judged inappropriate for the study by the principal. Target Size - 12

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 10 Month 07 Day Date of IRB - 2026 Year 10 Month 08 Day Anticipated trial start date - 2026 Year 10 Month 25 Day Last follow-up date - 2026 Year 12 Month 23 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072376

Disclaimer: Curated by HT Syndication.