UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000059422 |
|---|---|
| Receipt number | R000067958 |
| Scientific Title | Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults |
| Date of disclosure of the study information | 2025/10/15 |
| Last modified on | 2025/10/15 16:28:30 |
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Basic information
Public title
Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults
Acronym
Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults
Scientific Title
Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults
Scientific Title:Acronym
Exploratory study on the effects of amino acid-enriched food on cognitive function in community-dwelling older adults
Region
| Japan |
Condition
Condition
Healthy older adults
Classification by specialty
| Geriatrics | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Blocking
YES
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
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 sample size
80
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Shimada |
Organization
National Center for Geriatrics and Gerontology
Division name
Center for Gerontology and Social Science
Zip code
474-8511
Address
7-430 Morioka-machi, Obu city, Aichi
TEL
0562-44-5651(5680)
shimada@ncgg.go.jp
Public contact
Name of contact person
| 1st name | Chiharu |
| Middle name | |
| Last name | Nishijima |
Organization
National Center for Geriatrics and Gerontology
Division name
Department of Preventive Gerontology
Zip code
474-8511
Address
7-430 Morioka-machi, Obu city, Aichi
TEL
0562-44-5651(5687)
Homepage URL
c-nishijima@ncgg.go.jp
Sponsor or person
Institute
National Center for Geriatrics and Gerontology
Institute
Department
Personal name
Funding Source
Organization
Ajinomoto Co., Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Center for Geriatrics and Gereontology; Research and Medical Division
Address
7-430 Morioka-machi, Obu city, Aichi
Tel
0562-46-2311
yaday@ncgg.go.jp
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2025 | Year | 10 | Month | 15 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 10 | Month | 15 | Day |
Last modified on
| 2025 | Year | 10 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067958
