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 stress and sleep in worker: randomized, placebo-controlled, double blind trial
Title of the study (Brief title)	A study for evaluating the effect of the intake of a GABA-containing food on stress and sleep in worker
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 improvement effects of ingestion of GABA-containing food for 12 consecutive weeks on stress, quality of the sleep and fatigue in worker.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Sleep : PSQI Stress : POMS 2-A Short
Key secondary outcomes	Sleep : AIS Fatigue : VAS

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	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Ingestion of test food containing GABA for 12 consecutive weeks
Interventions/Control_2	Ingestion of placebo without GABA for 12 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	60 years-old >=
Gender	Male and Female
Key inclusion criteria	1) Males and females from 30 to 60 years of age 2) worker (full-time) 3) AIS score is more than 6 4) POMS 2-A FI T score is more than 50 and VA T score is less than 50
Key exclusion criteria	1) Subjects who routinely use food or medicine containing of GABA 2) Subjects who performs an act for the improvement of the fatigue, the quality of the sleep and stress 3) Night and day shift worker or manual laborer 4) Subjects who has a disease under treatment or are judged to that medical treatment are necessary by the doctor 5) Subjects who has under treatment or a history of sleep apnea syndrome or is strongly suspected of sleep apnea syndrome 6) Subjects who has had a diagnosis of chronic fatigue syndrome 7) Subjects who has 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 8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnair 9) Subjects having possibilities for emerging allergy related to the study 10) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination 11) 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 12) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating 13) Subjects who are judged as unsuitable for the study by the investigator for other reason
Target sample size	60

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	2015 Year 10 Month 10 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 09 Month 10 Day
Anticipated trial start date	2015 Year 10 Month 10 Day
Last follow-up date	2016 Year 02 Month 13 Day
Date of closure to data entry	2016 Year 02 Month 26 Day
Date trial data considered complete	2016 Year 03 Month 25 Day
Date analysis concluded	2016 Year 04 Month 12 Day

Related information
URL releasing protocol
Publication of results	Published
URL releasing results
Results	Compared with the placebo group, the GABA group showed a significant increase the vigor-activity scale measured by POMS 2 at week 6 relative to the baseline (P=0.045).
Other related information

Management information
Registered date	2015 Year 10 Month 10 Day
Last modified on	2017 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022245