UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000050337 |
|---|---|
| Receipt number | R000057311 |
| Scientific Title | The effect of intake of amino acid mixture on cognitive functions in middle-aged/elderly subjects: a randomized, double-blind, placebo-controlled study |
| Date of disclosure of the study information | 2023/02/15 |
| Last modified on | 2023/02/14 16:09:29 |
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Basic information
Public title
The effect of intake of amino acid mixture on cognitive functions in middle-aged/elderly people
Acronym
The effect of amino acid intake on cognitive functions
Scientific Title
The effect of intake of amino acid mixture on cognitive functions in middle-aged/elderly subjects: a randomized, double-blind, placebo-controlled study
Scientific Title:Acronym
The effect of intake of amino acid mixture on cognitive functions in middle-aged/elderly subjects
Region
| Japan |
Condition
Condition
None (Healthy adults)
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify the effect of amino acids intake for 12 weeks on cognitive function.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
<Cognitive function>
Battery Wechsler memory scale - revised
Logical Memory I/II
Figure Memory
Visual Pared association I/II
Verbal paired association I/II
Visual reproduction I/II
Trail Making Test, Part A & Part B(TMT-A,B)
Verbal Fluency Task
Key secondary outcomes
JST-Index of Competence
Pittsburgh Sleep Quality Index
WHO-5-J
SF-36v2 Standard Edition
Questionnaire about subjective cognitive decline
Amino acids and other metabolites
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Amino acids (Period: 12 weeks)
Interventions/Control_2
Placebo (Period: 12 weeks)
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
| 48 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Subjects from 48 to 75 years of age at the time of obtaining consent to participate in this study.
2) Subjects whose MMSE-J score is 26 or higher, and MoCA-J score less than 30.
3) Subjects who have noticeable symptoms of memory loss or whose memory loss has been pointed out by others.
4) Subjects who can make self-judgment and provided written informed consent.
Key exclusion criteria
1) Individuals who have a history of mental or cerebrovascular diseases.
2) CES-D score >= 16.
3) Individuals who use medicines which may affect central nervous system except for sleeping pills.
4) Individuals who regularly intake supplements or functional foods which may affect cognitive function.
5) Individuals who regularly intake supplements consisted of amino acids used in this study.
6) Individuals who have visual impairment or hearing impairment.
7) Individuals who are diagnosed with climacteric symptom or who have been treated with hormone replacement therapy.
8) Individuals who have a history of alcohol dependence.
9) Individuals who are under medical treatment of cancer or cirrhosis of liver.
10) Dialysis patients.
11) Individuals with phenylketonuria.
12) Blood donation within 4 weeks.
13) Individuals who have allergy of food provided on the day of assessment.
14) Individuals who participate or will participate in other clinical studies.
15) Individuals who are assessed to be inappropriate by the principal investigator due to other reasons.
Target sample size
116
Research contact person
Name of lead principal investigator
| 1st name | Kenji |
| Middle name | |
| Last name | Nagao |
Organization
Ajinomoto Co., Inc.
Division name
Research Institute For Biosciences&Fine Chemicals
Zip code
210-8681
Address
1-1 Suzuki-cho, Kawasaki-ku, Kawasaki-shi 210-8681, JAPAN
TEL
07010036372
kenji.nagao.df2@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Yoshika |
| Middle name | |
| Last name | Komori |
Organization
KSO Corporation
Division name
CEO
Zip code
105-0023
Address
1-9-7 Shibaura, Minato-ku, Toky
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
KSO corporation
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
Ethics Committee of Ajinomoto Co., Inc.
Address
1-15-1,Kyobashi, Chuo-ku, Tokyo
Tel
+81-3-5250-8134
ajinomoto_irb@ajinomoto.com
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
医療法人財団健康睡眠会 日本橋循環器科クリニック（東京都)
Other administrative information
Date of disclosure of the study information
| 2023 | Year | 02 | 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
| 2022 | Year | 10 | Month | 04 | Day |
Date of IRB
| 2022 | Year | 10 | Month | 27 | Day |
Anticipated trial start date
| 2023 | Year | 02 | Month | 15 | Day |
Last follow-up date
| 2023 | Year | 08 | Month | 19 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2023 | Year | 02 | Month | 14 | Day |
Last modified on
| 2023 | Year | 02 | Month | 14 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000057311
