Healthy older adults
Conditions
Interventions
Oral intake of 3 g of powder containing amino acids once daily
Oral intake of 3 g of powder without amino acids once daily
Sponsors
National Center for Geriatrics and Gerontology
Eligibility
Sex/Gender
All
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the following items measured at baseline (before intervention) and after 12 weeks of intake 1) NCGG-FAT composite score 2) Japanese version of Mini-Mental State Examination 3) Trail Making Test Part A, Trail Making Test Part B 4) Word list memory-I, Word list memory-II 5) Symbol Digit Substitution Task 6) Digit Span Test | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the following items measured at baseline (before intervention) and after 12 weeks of intake 1) World Health Organization-Five Well-Being Index, Japanese version (WHO-5-J) 2) Visual Analog Scale (VAS) assessments (overall fatigue, mental fatigue, physical fatigue, depression, relaxation, sleepiness, mental clarity, motivation, difficulty walking indoors, and unsteadiness while walking) 3) Total and regional muscle mass, skeletal muscle index (SMI), and extracellular water ratio (ECW/TBW) 4) Handgrip strength 5) Gait speed 6) Physical frailty | — |
Countries
Japan
Contacts
Public ContactTakuto OKUYA
National Center for Geriatrics and Gerontology Department of Preventive Gerontology
Outcome results
None listed