UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	The effect of amino acid ingestion on biological clock - placebo controlled, randomized, double-blind, cross-over study -
Title of the study (Brief title)	The effect of amino acid ingestion on biological clock
Region	Japan

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the effect of the repeated ingestion of amino acid on biological rhythm in human
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Melatonin concentration in saliva
Key secondary outcomes	Cortisol concentration in saliva

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	No need to know

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of amino acid (400 mg/day) for 7 days
Interventions/Control_2	Ingestion of placebo for 7 days
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	70 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Subject received an explanation for this study and gave written informed consent. (2) Subject is healthy and has no chronic disease. (3) Melatonin in saliva can be detectable. (4) Subject must be admitted to this study by the supervisor doctor.
Key exclusion criteria	(1) Subject receives treatment, or always uses medicines or quasi-drugs. (2) Subject is expected to use medicine during this study. (3) Subject is or has been serious diseases, thyroid gland disease, adrenal gland disease, or metabolic disorder. (4) Subject is or has been diseases related to sleep. (5) Subject has been diagnosed with xerostomia or has xerostomia symptoms. (6) Subject is or has been diagnosed with the drug or alchol dependence. (7) Subject has the possibility of drug and/or food allergy. (8) Subject is predict to occurred to have life events, which may affect their mental conditions, during this study. (9) Subject has a plan to participate in other study during this study. (10) Subject or his/her family work for a company on manufacturing or selling health foods or foods with function claims. (11) Subject can not sleep during night because of shift work or other reasons. (12) His/her native language is not Japanese. (13) Subject is judged as unsuitable for the study by pre test questionnaire. (14) Subject has a plan to become pregnant during the current study or are pregnant or lactating. (15) Subject has a considerable difference in results of motion sensor and pre-questionaires. (16) Subject has values significantly deviated from the reference range in body measurement values declared beforehand (17) Subject is judged inadequateness on this study by subject background questionnaire. (18) Subject has a plan to travel abroad during two weeks before this study starts and during this study. (19) Subject usually consumes food with functional claims and/or supplement which may affect melatonin secretion. (20) Subject is restricted intake of amino acid because he/she has been diagnosed with genetically deficient in metabolic enzyme. (21) Subject is judged inadequateness on this study by the supervisor doctor.
Target sample size	30

Research contact person
Name of lead principal investigator	Shigenobu Shibata
Organization	Waseda University
Division name	Faculty of Science and Engineering
Address	2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo, 162-8480, Japan
TEL	+81-3-5369-7318
Email	shibatas@waseda.jp

Public contact
Name of contact person	Atsushi Haraguchi
Organization	Waseda University
Division name	Graduate School of Advanced Science and Engineering
Address	2-2 Wakamatsu-cho, Shinjuku-ku, Tokyo, 162-8480, Japan
TEL	+81-3-5369-7318
Homepage URL
Email	hmar.h@fuji.waseda.jp

Sponsor
Institute	Waseda University
Institute
Department

Funding Source
Organization	Kirin Company
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	早稲田大学

Other administrative information
Date of disclosure of the study information	2017 Year 03 Month 28 Day

Progress
Recruitment status	No longer recruiting
Date of protocol fixation	2017 Year 03 Month 28 Day
Anticipated trial start date	2017 Year 04 Month 28 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2017 Year 03 Month 28 Day
Last modified on	2017 Year 09 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030699