UMIN-CTR Clinical Trial

Basic information
Public title	The study of relaxing and sleep effects from intake of test food containing gamma-Aminobutyric acid
Acronym	The study of relaxing and sleep effects from intake of test food containing gamma-Aminobutyric acid
Scientific Title	The study of relaxing and sleep effects from intake of test food containing gamma-Aminobutyric acid
Scientific Title:Acronym	The study of relaxing and sleep effects from intake of test food containing gamma-Aminobutyric acid
Region	Japan

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

Objectives
Narrative objectives1	To evaluate the relaxation effects from intake of intake of test food containing gamma-Aminobutyric acid and its effects on sleep
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	autonomic function test(LF,HF,LF/HF), Salivary Chromogranin A, OSA sleep inventory(MA version), VAS
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Food
Interventions/Control_1	Intake of test food containing gamma-Aminobutyric acid for 3 days before going to bed.
Interventions/Control_2	Listen to classical music for 3 days before going to bed.
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	60 years-old >
Gender	Male and Female
Key inclusion criteria	(1)Japanese men and women whose age at the time of obtaining consent is 20 to 59 years old (2)Subjects who are dissatisfied with sleep (trouble with sleep, waking up in the middle of the night , poor sleep, daytime sleepiness) (3)Subjects whose Pittsburgh Sleep Quality Index(PSQI) score is over 6 points
Key exclusion criteria	(1) Subjects participating in other clinical trials (2) Subjects who are pregnant or may be pregnant, and those who are breastfeeding (3)Subjects who may have allergic reactions due to the ingredients of the test product (4)Subjects who go to the hospital / taking medication / obtaining treatment (5)Subjects using implantable medical electrical equipment such as pacemakers and implantable cardioverter-defibrillators that are susceptible to electromagnetic interference (6)Subjects using wearable medical electrical equipment such as electrocardiographs (7)Subjects with chronic diseases or disorders of the liver, biliary tract, digestive system, circulatory system, respiratory system, kidney, urinary system, psychiatry, nervous system, and blood system (8)Subjects with sleep apnea (9)Subjects with asthma (10)Subjects whose lifestyle may change during the examination period (night shift, long trip, work transfer, etc.) (11)Subjects whose working hours are not stable due to irregular shift work and late night work, etc. (12) Subjects with acute pain disorders such as spinal fractures, sprains, and strains (13)Subjects who need rest due to physical or mental illness or disability (14)Subjects with high blood pressure (15)Subjects with arrhythmia (16)Subjects who need the assistance of others and cannot come to the hospital during the test period by themselves (17)Subjects who cannot quit smoking or quit smoking for four days during the exam period, including the day before the exam period (18)Subjects who cannot stop taking caffeine drinks after dinner for four days during the exam period, including the day before the exam period (19)Subjects who live with preschool children (20)Subjects who have thick hair and cannot attach electrodes to their chest
Target sample size	30

Research contact person
Name of lead principal investigator	1st name Takashi Middle name Last name Koikeda
Organization	Shiba Palace Clinic
Division name	Chair
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1590
Email	jimukyoku@mail.souken-r.com

Public contact
Name of contact person	1st name Ko Middle name Last name Masuda
Organization	SOUKEN Co., Ltd
Division name	Management Division
Zip code	105-0013
Address	DaiwaA Hamamatsucho Bldg. 3F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
TEL	03-5408-1555
Homepage URL
Email	k_masuda@mail.souken-r.com

Sponsor
Institute	Shiba Palace Clinic
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	Shiba Palace Clinic Ethics Review Committee
Address	DaiwaA Hamamatsucho Bldg. 6F, 1-9-10, Hamamatsucho, Minato-ku, Tokyo, 105-0013, JAPAN
Tel	03-5408-1599
Email	shiba_palace@s-palace-clinic.com

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	2022 Year 06 Month 30 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	2021 Year 10 Month 14 Day
Date of IRB	2021 Year 10 Month 14 Day
Anticipated trial start date	2021 Year 10 Month 14 Day
Last follow-up date	2021 Year 12 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 15 Day
Last modified on	2022 Year 10 Month 17 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052238