UMIN-CTR Clinical Trial

Basic information
Public title	Effect on the QOL related to sleep by amino acids intake to healthy adult male and female.
Acronym	Effect on the QOL related to sleep by amino acids intake.
Scientific Title	Effect on the QOL related to sleep by amino acids intake to healthy adult male and female.
Scientific Title:Acronym	Effect on the QOL related to sleep by amino acids intake.
Region	Japan

Condition
Condition	Healthy adult
Classification by specialty	Hepato-biliary-pancreatic medicine Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To evaluate the effect of the QOL related to sleep when compared to placebo for healthy adult male and female workers who consume test food for one week.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	OSA sleep inventory MA version, Japanese short version of POMS2
Key secondary outcomes	Total time of deep sleep, Total time of sleep, sleep latency, LF/HF ratio, HF

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	Intake of food containing amino acids for 1 week
Interventions/Control_2	Intake of food containing amino acids and L-theanine for 1 week
Interventions/Control_3	Intake of placebo food for 1 week
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	64 years-old >=
Gender	Male and Female
Key inclusion criteria	(1) Healthy adult male and female workers from 20 to 64 years of age (2) The total score of the Zc of OSA sleep inventory MA version is low
Key exclusion criteria	(1) Subjects who constantly use health food richly containing involvement ingredient (2) Subjects who perform an act for the improvement of the quality of the sleep, the stress, and fatigue (3) Subjects whose BMI are 30.0 kg/m^2 or more (4) Subjects who wake up halfway or more due to nighttime urination, child's crying at night, etc. (5) Night and day shift worker or manual laborer (6) During the treatment of diseases affecting sleep or pulse, such as sleep apnea syndrome, chronic fatigue syndrome, autonomic imbalance and the like, a subject having a diagnosis history or a subject to be strongly suspected (7) Subjects of constitution / body that are thought to interfere with wearing of wearable activity meter (8) Subjects who may feel stress due to abstinence or quitting smoking and may affect sleep (9) Subjects who have the potential of developing pollinosis during the study (10) Subjects who have under treatment or a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease) and disease to affect the adrenal cortical hormone secretion (11) Subjects having possibilities for emerging allergy related to the study (12) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required (13) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection (14) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies (15) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study (16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (17) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size	60

Research contact person
Last name of lead principal investigator	1st name Hiroshi Middle name Last name Kawabata
Organization	EZAKI GLICO Co., Ltd.
Division name	R&D LABORATORY
Zip code	555-8502
Address	4-6-5, UTAJIMA, NISHIYODOGAWA-KU, OSAKA
TEL	06-6477-8793
Email	hiroshi.kawabata@glico.com

Public contact
1st name of contact person	1st name Shinsuke Middle name Last name Tsuji
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Zip code	150-0021
Address	Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	s.tsuji@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co., Ltd
Institute
Department

Funding Source
Organization	EZAKI GLICO Co., Ltd.
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	Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address	2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel	03-6455-0880
Email	t.saito@ttc-smo.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	2018 Year 10 Month 26 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	60
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 10 Month 11 Day
Date of IRB	2018 Year 10 Month 11 Day
Anticipated trial start date	2018 Year 10 Month 27 Day
Last follow-up date	2018 Year 12 Month 08 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2018 Year 10 Month 26 Day
Last modified on	2019 Year 05 Month 24 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000039520