UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000033174
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email yoshi@kso.co.jp

Sponsor
Institute Tokyo Metropolitan Institute of Gerontology
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037779

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.