Clinical Trial: Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults (Japan)

Tokyo, Oct. 16 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000059422) titled 'Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults' on Oct. 15.

Study Type: Interventional

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

Primary Sponsor: Institute - National Center for Geriatrics and Gerontology

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

Objective: Narrative objectives1 - To examine the effects of consuming amino acid-enriched food once daily (3 g per serving) for 12 weeks on geriatric syndromes, with a particular focus on cognitive function Basic objectives2 - Efficacy

Intervention: Interventions/Control_1 - Oral intake of 3 g of powder containing amino acids once daily Interventions/Control_2 - Oral intake of 3 g of powder without amino acids once daily

Eligibility: Age-lower limit - 60 years-old <= Age-upper limit - Not applicable Gender - Male and Female Key inclusion criteria - (a) Individuals aged 60 years or older at the time of providing consent (b) Individuals who have participated in the Health Check-up conducted by the National Center for Geriatrics and Gerontology (NCGG) (Ethics approval No. 1909) (c) Individuals who will undergo the Functional Assessment conducted by the NCGG in Takahama City, Aichi, scheduled between January and April 2026 (d) Individuals scoring 26 or higher on the Japanese version of the Mini-Mental State Examination (MMSE-J) (e) Individuals who report subjective memory complaints, assessed using the "Self-Check List for Early Signs of Dementia"; those with a total score between 6 and 19 will be eligible for inclusion (f) Individuals who are able to continue the specified intervention for the full study period (g) Individuals who have received a full explanation of the study and have provided written informed consent to participate Key exclusion criteria - (a) Individuals diagnosed with dementia or mild cognitive impairment (MCI) (b) Individuals with a history of psychiatric disorders (including bipolar disorder, anxiety disorder, attention-deficit/hyperactivity disorder), autoimmune diseases, neurological disorders (such as epilepsy or Parkinson's disease), or cerebrovascular disease (c) Individuals with amino acid metabolism disorders (d) Individuals receiving dialysis (e) Individuals undergoing treatment for cancer (f) Individuals undergoing treatment for liver cirrhosis (g) Individuals with allergies to dairy products (h) Individuals diagnosed with lactose intolerance (i) Individuals with phenylketonuria (PKU) (j) Individuals with a score of 6 or higher on the Japanese version of the Geriatric Depression Scale, Short Form (GDS-S-J) (k) Individuals with visual or hearing impairments that interfere with activities of daily living (l) Individuals with a history of alcohol dependence (m) Individuals who habitually consume large amounts of alcohol (60 g and over/day on 5 days and over per week) (n) Individuals who regularly use supplements or health foods labeled for improving cognitive function (e.g., Suntory Omega Aid, Kenno Help, Nature Made Ginkgo Leaf, Nokatsu Seven Amino, DHA & EPA, Memory-maintaining chewing gum, etc.) at least five days per week (o) Individuals who are taking amino acid preparations (e.g., Livact, Aminoleban, Aminofreed) (p) Individuals who regularly use amino acid or protein supplements at least five days per week (q) Individuals with a Trail Making Test Part B (TMT-B) score more than 1.5 standard deviations below the mean (r) Individuals who work night shifts at least two days per week (s) Individuals who are currently participating in another clinical study or plan to participate in another study during the intervention period (t) Any other individuals deemed ineligible for participation by the investigators Target Size - 80

Recruitment Status: Recruitment status - Preinitiation Date of protocol fixation - 2025 Year 10 Month 01 Day Date of IRB - 2025 Year 10 Month 09 Day Anticipated trial start date - 2026 Year 02 Month 20 Day Last follow-up date - 2026 Year 05 Month 22 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067958

Disclaimer: Curated by HT Syndication.