UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019308 |
|---|---|
| Receipt number | 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 17:57:41 |
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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
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
h.shimada@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co.,Ltd.
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022245
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
