UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033174 |
|---|---|
| Receipt number | R000037779 |
| Scientific Title | Double blind comparative study of effects of amino acids-enriched food on brain function in elderly subjects |
| Date of disclosure of the study information | 2018/07/25 |
| Last modified on | 2019/06/19 17:22:03 |
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Basic information
Public title
Double blind comparative study of effects of amino acids-enriched food on brain function in elderly subjects
Acronym
Evaluation of effects of amino acids-enriched food on brain function in elderly subjects
Scientific Title
Double blind comparative study of effects of amino acids-enriched food on brain function in elderly subjects
Scientific Title:Acronym
Evaluation of effects of amino acids-enriched food on brain function in elderly subjects
Region
| Japan |
Condition
Condition
Healthy subjects
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of amino acid-enriched foods on brain function in elderly subjects
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Cognitive function Battery
Key secondary outcomes
*Secondary outcomes
SF-36, WHO-5-J, Questionnaire survey (Related to Activity, Cognitive decline, Social involvement, Care prevention, Social capital, Multidimensional Empathy Scale, VAS), Amino acids and other metabolites
*Safety
Adverse event, side effect, blood pressure, pulse rate, BMI, clinical test result
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Placebo
Interventions/Control_2
Low-dose amino acid-enriched food
Interventions/Control_3
Medium-dose amino acid-enriched food
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
| 55 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) Subjects whose MMSE-J score is 26 or higher, and MoCA-J score less than 30.
2) Subjects who have noticeable symptoms of memory loss or whose memory loss has been pointed out by others.
3) Subjects who provided written informed consent.
Key exclusion criteria
1) Individuals who have a history of mental or cerebrovascular diseases.
2) GDS-S-J score above 6.
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 have visual impairment or hearing impairment.
6) Individuals who have a history of alcohol dependence.
7) Individuals who are under medical treatment of cancer or cirrhosis of liver.
8) Dialysis patients.
9) Individuals who have allergy of milk or lactose intolerance.
10) Individuals with phenylketonuria.
11) Individuals who participate or will participate in other clinical studies.
12) Individuals who are assessed to be inappropriate by the principal investigator due to other reasons.
Target sample size
105
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroyuki Suzuki |
Organization
Tokyo Metropolitan Institute of Gerontology
Division name
Research Team for Social Participation and Community Health
Zip code
Address
35-2 Sakae-cho, Itabashi-ku, Tokyo, Japan
TEL
03-3964-3241
suzukihy@tmig.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshika Komori |
Organization
KSO Corporation
Division name
Executive chairman
Zip code
Address
1-9-7 Shibaura, Minato-ku, Tokyo, Japan
TEL
03-3452-7733
Homepage URL
yoshi@kso.co.jp
Sponsor or person
Institute
Tokyo Metropolitan Institute of 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
Address
Tel
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
地方独立行政法人東京都健康長寿医療センター研究所／Tokyo Metropolitan Institute of Gerontology.
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 07 | Month | 25 | 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
Completed
Date of protocol fixation
| 2018 | Year | 05 | Month | 31 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 05 | Day |
Anticipated trial start date
| 2018 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2019 | Year | 05 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 28 | Day |
Last modified on
| 2019 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037779
