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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000019308
Receipt No. R000022245
Scientific Title 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
Date of disclosure of the study information 2015/10/10
Last modified on 2017/01/12

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Basic information
Public title 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
Acronym A study for evaluating the effect of the intake of a GABA-containing food on stress and sleep in worker
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Hideki Hokazono
Organization SANWA SHURUI Co., Ltd.
Division name Research Laboratory
Zip code
Address 2231-1, Yamamoto, Usa, Oita
TEL 0978-33-3844
Email hokazono-h@kokuzo.co.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hiroyasu Shimada
Organization TTC Co., Ltd.
Division name Clinical Research Planning Department
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
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).
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
2015 Year 09 Month 10 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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