Tokyo, May 28 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000061700) titled 'Effect of the Test Food on Cognitive Function in Japanese Adults: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study' on May 27.

Study Type: Interventional

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

Primary Sponsor: Institute - FANCL Corporation

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

Objective: Narrative objectives1 - To investigate the effects of continuous intake of food containing plant extracts for 16 weeks on cognitive function in Japanese male and female aged 40 to under 60 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Continuous intake of food containing plant extract for 16 weeks. Interventions/Control_2 - Continuous intake of placebo for 16 weeks.

Eligibility: Age-lower limit - 40 years-old

Gender - Male and Female Key inclusion criteria - 1.Japanese males and females aged 40 to under 60 years at the time of written informed consent. 2.Subjects who feel they are experiencing cognitive decline (with a total SCD-Q (My-Cog) score of 7 or higher) 3.Subjects who are fully informed of the purpose and details of the study, capable of giving informed consent, and volunteering to participate in the study based on a full understanding of it, and who have given written informed consent to participate in the study. Key exclusion criteria - 1.Subjects with a history of gastrointestinal resection surgery (excluding appendectomy). 2.Subjects with an MMSE score of 27 or lower. 3.Subjects who have been diagnosed with dementia or mild cognitive impairment (MCI). 4.Subjects with a serious illness under treatment or a history of serious disease requiring medication. 5.Subjects with a history of diagnosis or treatment for psychiatric disorders (e.g., depression), or who are considered to have unstable psychiatric symptoms during the study period. 6.Subjects who have been continuously consuming drugs, Foods for Specified Health Uses, Foods with Function Claims, or health foods that may affect study outcomes at least 3 days per week over the past 3 months, and who are unable to discontinue such intake from one month before the baseline examination. 7.Subjects who have a history of or currently receive treatment for cerebrovascular disease (e.g., cerebral/subarachnoid hemorrhage, cerebral infarction/ transient ischemic attacks, cerebral aneurysm, and moyamoya disease), or who had a traumatic injury to the head within the past 10 years. 8.Subjects who have color vision deficiency or hearing impairment that may affect the cognitive function tests or other study assessments. 9.Subjects who have undergone cognitive function tests (e.g., neuropsychological assessments of memory and attention) within the past 12 months. 10.Subjects who have specialized knowledge of the memory and cognitive function tests used in this study. 11.Subjects who are at risk of developing allergic reactions to any study-related procedures or materials. 12.Subjects who intend to become pregnant during the study period, are pregnant (or may be pregnant), or are breastfeeding. 13.Subjects with extremely irregular lifestyles due to night shift work or rotating shift work. 14.Subjects whose lifestyle habits, including eating and sleeping patterns, are extremely irregular. Target Size - 110

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 05 Month 20 Day Date of IRB - 2026 Year 05 Month 21 Day Anticipated trial start date - 2026 Year 05 Month 28 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=R000070596

Disclaimer: Curated by HT Syndication.