Tokyo, Oct. 9 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000062923) titled 'Efficacy Evaluation study of a test food for maintaining cognitive function' on Oct. 9.

Study Type: Interventional

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

Primary Sponsor: Institute - IMEQRD Co. Ltd.

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

Objective: Narrative objectives1 - To evaluate the effect of 24-week continuous intake of the test food on maintaining cognitive function in Japanese men and women aged 55 to under 80 years. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Participants will consume three pieces per day of the test food (containing potato ceramide extract) with water or lukewarm water. Interventions/Control_2 - Participants will consume three pieces per day of the placebo (without potato ceramide extract) with water or lukewarm water.

Eligibility: Age-lower limit - 55 years-old

Gender - Male and Female Key inclusion criteria - -Aged 55 to under 80 years at consent -Japanese men and women -Self-awareness of memory loss or have been pointed out to have memory loss -Mini-Mental Sate Examination (MMSE) total score of 24 or higher at SCR2 -Able to enter electronic diaries via smartphone or PC -Voluntarily consented in writing after receiving sufficient explanation and understanding of the study's purpose and content Key exclusion criteria - -Suspected cognitive impairment due to metabolic disease, head injury, normal pressure hydrocephalus, epilepsy, encephalitis, or meningitis -Comorbid or suspected neurodegenerative diseases presenting with dementia-like symptoms (e.g., Parkinson's disease, dementia with Lewy bodies, frontotemporal dementia, Huntington's disease, progressive supranuclear palsy, corticobasal degeneration, multiple system atrophy, multiple sclerosis) -Current or past unstable or severe psychiatric disorders, including sleep apnea (on CPAP), major depression, bipolar disorder, schizophrenia, alcohol or substance dependence -History of cerebrovascular disease (e.g., past TIA, post-treatment epilepsy) -Scheduled hospitalization (including for tests) at consent -Current or past use of medications affecting cognition (e.g., antidepressants) -Current or past serious diseases that may affect the study (e.g., severe heart or liver disease) -Use of hearing aids due to age-related hearing loss -Eye disorders affecting eye-tracking cognitive assessments -History of gastrointestinal surgery (except appendicitis) -Regular intake (3 or more times a week) of products affecting cognition (e.g., certain supplements or foods), unless discontinued after consent -Regular use (3 or more times a week) of devices or apps affecting cognition (e.g., brain training), unless discontinued after consent -Current or past food or drug allergies -taking alcohol more than 40 g/day -with excessive daily smoking: 20 or more cigarettes a day -Shift workers with night shifts -Plans to significantly change lifestyle (diet, sleep, exercise) during the study -Plans for overseas travel during the study -Blood donation or sampling exceeding 200ml in the past month or 400ml in the past 3 months, or planned during the study -Participation in other clinical studies within 1 month before consent, currently, or planned during the study -Deemed unsuitable for participation by the principal investigator Target Size - 100

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2026 Year 08 Month 18 Day Anticipated trial start date - 2027 Year 02 Month 17 Day Last follow-up date - 2027 Year 08 Month 06 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000072040

Disclaimer: Curated by HT Syndication.