UMIN-CTR Clinical Trial

Basic information
Public title	Effects of short-term amino acid intake on sleep in the elderly and healthy adults Effects on Sleep
Acronym	short-term amino acid intake test
Scientific Title	short-term amino acid intake test
Scientific Title:Acronym	short-term amino acid intake test
Region	Japan

Condition
Condition	The purpose of this study is to examine the differences in the effects of amino acid administration on sleep, amino acid metabolism, and oxidative stress between different ages, and to investigate the differences in the effects of age on these effects, in order to solve both the problem of sleep and the nutritional deficiency caused by the lack of protein in the morning.
Classification by specialty	Not applicable
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Exploratory study of amino acid administration
Basic objectives2	Others
Basic objectives -Others	Effect of Amino Acids on Oxidative Stress
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	sleep
Key secondary outcomes	oxidative stress

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	single dose
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	20 years-old <=
Age-upper limit	80 years-old >
Gender	Male and Female
Key inclusion criteria	healthy
Key exclusion criteria	people with test food intolerance
Target sample size	10

Research contact person
Name of lead principal investigator	1st name Yutaka Middle name Last name Taketani
Organization	The University of Tokushima
Division name	Department of Clinical Nutrition and Management
Zip code	7700006
Address	18-15, Kuramoto-cho 3-chome, Tokushima City
TEL	0886337093
Email	okumurah@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Hisami Middle name Last name Okumura
Organization	The University of Tokushima
Division name	Department of Clinical Nutrition and Management
Zip code	7708503
Address	18-15, Kuramoto-cho 3-chome, Tokushima City
TEL	0886337093
Homepage URL
Email	okumurah@tokushima-u.ac.jp

Sponsor
Institute	The University of Tokushima
Institute
Department

Funding Source
Organization	The University of Tokushima
Organization
Division
Category of Funding Organization	Government offices of other countries
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Center for Integrated Clinical Research, The University of Tokushima Hospital
Address	2-50-1, Kuramoto-cho, Tokushima City, Tokushima Prefecture
Tel	088-633-9294
Email	first-ec@tokushima-u.ac.jp

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	2024 Year 04 Month 01 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 02 Month 07 Day
Date of IRB
Anticipated trial start date	2022 Year 03 Month 28 Day
Last follow-up date	2022 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2022 Year 02 Month 07 Day
Last modified on	2022 Year 02 Month 07 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000053442