UMIN-CTR Clinical Trial

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

Condition
Condition	Healthy, elderly
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Examination of the effects of long-term intake of amino acid powder on sleep and oxidative stress
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Explanatory
Developmental phase	Not applicable

Assessment
Primary outcomes	The primary endpoint will be a sleep questionnaire. (3 and 6 weeks after intake)
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Take glycine for 6 weeks. 0.05 g/kg for the first 3 weeks and 0.1 g/kg for the following 3 weeks.
Interventions/Control_2	Take alanine for 6 weeks. 0.05 g/kg for the first 3 weeks and 0.1 g/kg for the following 3 weeks.
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	Ability to consume amino acid powders.
Key exclusion criteria	People who cannot take the amino acid powder. In addition, people who cannot obtain permission to participate in the study from their doctor, if they have one.
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Hisami Middle name Last name Okumura
Organization	Tokushima university
Division name	Department of Clinical Nutrition and Food Management
Zip code	770-8503
Address	kuramoto-cho 3-18-15, Tokushima-city
TEL	088-633-7093
Email	okumurah@tokushima-u.ac.jp

Public contact
Name of contact person	1st name Hisami Middle name Last name Okumura
Organization	Tokushima university
Division name	Department of Clinical Nutrition and Food Management
Zip code	770-8503
Address	kuramoto-cho 3-18-15, Tokushima-city
TEL	088-633-7093
Homepage URL
Email	okumurah@tokushima-u.ac.jp

Sponsor
Institute	Tokushima university
Institute
Department

Funding Source
Organization	MEXT(Japan)
Organization
Division
Category of Funding Organization	Japanese Governmental office
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)	Noom Japan, Charitable Trust Suzuyo Nakatani Memorial Nutrition Improvement Activity Promotion Fund

IRB Contact (For public release)
Organization	University Hospital of Tokushima Clinical Trial Center for Developmental Therapeutics
Address	kuramoto-cho,2-50-1, Tokushima-city
Tel	088-633-7958
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	2023 Year 03 Month 31 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	2021 Year 04 Month 01 Day
Date of IRB
Anticipated trial start date	2021 Year 11 Month 05 Day
Last follow-up date	2023 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2021 Year 10 Month 02 Day
Last modified on	2021 Year 10 Month 02 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052106