UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045759 |
|---|---|
| Receipt number | R000052238 |
| Scientific Title | The study of relaxing and sleep effects from intake of test food containing gamma-Aminobutyric acid |
| Date of disclosure of the study information | 2022/06/30 |
| Last modified on | 2022/10/17 12:02:05 |
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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
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
k_masuda@mail.souken-r.com
Sponsor or person
Institute
Shiba Palace Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052238
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