UMIN-CTR Clinical Trial

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