UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034664 |
|---|---|
| Receipt number | R000039520 |
| Scientific Title | Effect on the QOL related to sleep by amino acids intake to healthy adult male and female. |
| Date of disclosure of the study information | 2018/10/26 |
| Last modified on | 2019/05/24 17:04:44 |
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Basic information
Public title
Effect on the QOL related to sleep by amino acids intake to healthy adult male and female.
Acronym
Effect on the QOL related to sleep by amino acids intake.
Scientific Title
Effect on the QOL related to sleep by amino acids intake to healthy adult male and female.
Scientific Title:Acronym
Effect on the QOL related to sleep by amino acids intake.
Region
| Japan |
Condition
Condition
Healthy adult
Classification by specialty
| Hepato-biliary-pancreatic medicine | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of the QOL related to sleep when compared to placebo for healthy adult male and female workers who consume test food for one week.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OSA sleep inventory MA version,
Japanese short version of POMS2
Key secondary outcomes
Total time of deep sleep, Total time of sleep, sleep latency, LF/HF ratio, HF
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
3
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Intake of food containing amino acids for 1 week
Interventions/Control_2
Intake of food containing amino acids and L-theanine for 1 week
Interventions/Control_3
Intake of placebo food for 1 week
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
(1) Healthy adult male and female workers from 20 to 64 years of age
(2) The total score of the Zc of OSA sleep inventory MA version is low
Key exclusion criteria
(1) Subjects who constantly use health food richly containing involvement ingredient
(2) Subjects who perform an act for the improvement of the quality of the sleep, the stress, and fatigue
(3) Subjects whose BMI are 30.0 kg/m^2 or more
(4) Subjects who wake up halfway or more due to nighttime urination, child's crying at night, etc.
(5) Night and day shift worker or manual laborer
(6) During the treatment of diseases affecting sleep or pulse, such as sleep apnea syndrome, chronic fatigue syndrome, autonomic imbalance and the like, a subject having a diagnosis history or a subject to be strongly suspected
(7) Subjects of constitution / body that are thought to interfere with wearing of wearable activity meter
(8) Subjects who may feel stress due to abstinence or quitting smoking and may affect sleep
(9) Subjects who have the potential of developing pollinosis during the study
(10) 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
(11) Subjects having possibilities for emerging allergy related to the study
(12) Subjects having a disease requiring treatment or a history of serious diseases for which medication was required
(13) Subjects who are judged as unsuitable for the study because of clinical test, anthropometric test and physical examination in pre-inspection
(14) Subjects who have participated in other clinical study within the last one month or have plan to participate other clinical studies
(15) Subjects who are pregnant or lactating, or plan to become pregnant or lactate during the study
(16) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(17) Subjects who are judged as unsuitable for the study by investigator for other reasons
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroshi |
| Middle name | |
| Last name | Kawabata |
Organization
EZAKI GLICO Co., Ltd.
Division name
R&D LABORATORY
Zip code
555-8502
Address
4-6-5, UTAJIMA, NISHIYODOGAWA-KU, OSAKA
TEL
06-6477-8793
hiroshi.kawabata@glico.com
Public contact
Name of contact person
| 1st name | Shinsuke |
| Middle name | |
| Last name | Tsuji |
Organization
TTC Co., Ltd.
Division name
Clinical Research Planning Department
Zip code
150-0021
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.tsuji@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd
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
Aisei Hospital Ueno Clinic Reserch Ethics Committee
Address
2-18-6, Higashiueno, Taitou-ku, Tokyo
Tel
03-6455-0880
t.saito@ttc-smo.jp
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
| 2018 | Year | 10 | Month | 26 | 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
60
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
| 2018 | Year | 10 | Month | 11 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 11 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 12 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 10 | Month | 26 | Day |
Last modified on
| 2019 | Year | 05 | Month | 24 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039520
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| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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