UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females
Title of the study (Brief title)	A study for evaluating the effect of the intake of a GABA-containing food on electroencephalography during sleep in adult males and females
Region	Japan

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

Objectives
Narrative objectives1	This study aims to evaluate the effects of intake of GABA-containing food for 2 consecutive weeks on stress, sleep quality, fatigue, and electroencephalography during sleep compared to placebo.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Stress: POMS 2-A Short Sleep: electroencephalography
Key secondary outcomes	Fatigue: Fatigue VAS Sleep: OSA Sleep Inventory for Middle-Aged and Aged

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	Intake of a GABA - containing food for 2 consecutive weeks - washout period of 2 weeks - intake of placebo for 2 consecutive weeks
Interventions/Control_2	Intake of placebo for 2 consecutive weeks - washout period of 2 weeks - intake of a GABA-containing food for 2 consecutive 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	30 years-old <=
Age-upper limit	59 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Male and female workers from 30 to 59 years of age 2) Pittsburgh sleep quality index global score is greater than or equal to 6 3) POMS 2-AS FI T score is greater than or equal to 50 and VA T score is less than or equal to 50
Key exclusion criteria	1) Subjects who routinely use food or medicine containing of GABA 2) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep, and stress 3) Subjects who routinely intake foods that possibly affect sleep, stress, and fatigue 4) Subjects who wake after sleep onset for nocturia twice and more than twice a week 5) Subjects who have a possibility of feeling stress and affecting sleep due to abstinence 6) Subjects who have a history of hay fever 7) Night and day shift worker or manual laborer 8) Subjects who have a disease under treatment or are judged to that medical treatment are necessary by the doctor 9) Subjects who have under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 10) Subjects who have had a diagnosis of chronic fatigue syndrome 11) 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 12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires 13) Subjects having possibilities for emerging allergy related to the study 14) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 15) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study 16) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 17) Subjects who are judged as unsuitable for the study by the investigator for other reasons
Target sample size	32

Research contact person
Name of lead principal investigator	Hideki Hokazono
Organization	Sanwa Shurui Co., Ltd.
Division name	Research Laboratory
Address	2231-1, Yamamoto, Usa, Oita
TEL	0978-33-3844
Email	hokazono-h@kokuzo.co.jp

Public contact
Name of contact person	Hiroyasu Shimada
Organization	TTC Co., Ltd.
Division name	Clinical Research Planning Department
Address	1-20-2, Ebisunishi, shibuya-ku, Tokyo
TEL	03-5459-5329
Homepage URL
Email	h.shimada@ttc-tokyo.co.jp

Sponsor
Institute	TTC Co.,Ltd.
Institute
Department

Funding Source
Organization	Sanwa Shurui Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization

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

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	2017 Year 03 Month 24 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 03 Month 23 Day
Anticipated trial start date	2017 Year 03 Month 25 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	Published
URL releasing results
Results	GABA significantly decreased the total non-rapid eye movement (non-REM) sleep stage 2. In stratified analysis based on stress, the total time of non-REM sleep stage 3 in the layer above the mean value of confusion-bewilderment, anger-hostility, tension-anxiety, total mood disturbance score of the Profile of Mood States 2nd edition (POMS2) were significantly increased in the GABA intake period compared to the placebo. In stratified analysis by fatigue feeling, the total time of non-REM sleep stage 3 at the time of ingesting GABA in the layer where the fatigue VAS prior to ingestion exceeded the average value significantly increased compared to placebo. Stratified analysis based on age, the total time of non-REM sleep stage 3 at the time of ingestion of GABA in the stratum above the average age was significantly increased compared to placebo.
Other related information

Management information
Registered date	2017 Year 03 Month 23 Day
Last modified on	2018 Year 06 Month 07 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000030558