UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000041920 |
|---|---|
| Receipt number | R000047843 |
| Scientific Title | Correlation analysis of lifestyle factors related to cognitive function and blood amino acids |
| Date of disclosure of the study information | 2020/09/28 |
| Last modified on | 2025/10/01 09:31:53 |
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Basic information
Public title
Correlation analysis of lifestyle factors related to cognitive function and blood amino acids
Acronym
Correlation analysis of lifestyle factors related to cognitive function and blood amino acids
Scientific Title
Correlation analysis of lifestyle factors related to cognitive function and blood amino acids
Scientific Title:Acronym
Correlation analysis of lifestyle factors related to cognitive function and blood amino acids
Region
| Japan |
Condition
Condition
Healthy person
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analyzing the relationship between intakes of amino acid / nutrient and blood levels.
Basic objectives2
Others
Basic objectives -Others
NONE
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
Intakes and blood levels of amino acid and nutrient.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 50 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Japanese over the age of 50.
MMSE(Mini Mental State Examination)score is over 24 points.
Score of GDS-J (Geriatric Depression Scale-Japanese version) is less than 6 points.
Person who is independent in daily life.
Person who has obtained the informed consent of the document.
Person who has obtained the prior consent for the secondary use of acquired data.
Key exclusion criteria
Person who has taken any amino acid-formulations, supplements, and bevarage within 10 hours before the blood collection.
Person who has taken meals within 10 hours before the blood collection.
Person who has been educated for less than 6 years.
Person who has previous history or is under medical treatment for alcohol addiction.
Patient of cancer, cirrhosis of liver or dementia.
Patient who has to undergo dialysis.
Patient who developed other neurodegenerative or mental disorders.
In addition to above, patient who is judged as ineligible by the medical doctors who are responsible for this trial as investigators.
Target sample size
125
Research contact person
Name of lead principal investigator
| 1st name | Sakino |
| Middle name | |
| Last name | Toue |
Organization
AJINOMOTO CO., INC.
Division name
Research Institute for Bioscience Products & Fine Chemicals
Zip code
2108681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
+81-044-210-5835
sakino.toue.a4v@asv.ajinomoto.com
Public contact
Name of contact person
| 1st name | Hitomi |
| Middle name | |
| Last name | Kitamura |
Organization
AJINOMOTO CO., INC.
Division name
Research Institute for Bioscience Products & Fine Chemicals
Zip code
2108681
Address
1-1, Suzuki-cho, Kawasaki-ku, Kawasaki-shi, Kanagawa
TEL
+81-044-210-5835
Homepage URL
hitomi.kitamura01.mx9@asv.ajinomoto.com
Sponsor or person
Institute
AJINOMOTO CO., INC.
Research Institute for Bioscience Products & Fine Chemicals
Institute
Department
Personal name
Funding Source
Organization
AJINOMOTO CO., INC.
Research Institute for Bioscience Products & Fine Chemicals
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
R&B planning department
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
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 09 | Month | 28 | 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
125
Results
-
Results date posted
| 2025 | Year | 10 | Month | 01 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Japanese men and women aged 50 years or older,
including those suspected of cognitive decline(MiniMental State Examination 24-27 points)
Participant flow
After the preliminary questionnaire survey, fasting blood samples were collected.
Adverse events
-
Outcome measures
Primary Evaluation Items
-Intake amount and frequency of amino acids and nutrients
-Blood concentrations of amino acids, amino acid metabolites, and nutrients
-Clinical laboratory tests
-Subject background information
-Neuropsychological tests (MMSE,GDS-15)
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2020 | Year | 02 | Month | 20 | Day |
Date of IRB
| 2020 | Year | 02 | Month | 10 | Day |
Anticipated trial start date
| 2020 | Year | 03 | Month | 02 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
NONE
Management information
Registered date
| 2020 | Year | 09 | Month | 28 | Day |
Last modified on
| 2025 | Year | 10 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047843
