UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000027330 |
|---|---|
| Receipt number | R000031314 |
| Scientific Title | A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep in adult workers. |
| Date of disclosure of the study information | 2017/05/12 |
| Last modified on | 2017/10/05 17:05:06 |
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Basic information
Public title
A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep in adult workers.
Acronym
A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep.
Scientific Title
A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep in adult workers.
Scientific Title:Acronym
A study to evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep.
Region
| Japan |
Condition
Condition
None
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the effect of intake of Watanabe Oyster DHMBA Jelly on the status of stress, fatigue and sleep for 4 weeks.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
POMS-S, OSA sleep inventory MA version
Key secondary outcomes
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 the test product for 4 weeks
Interventions/Control_2
Ingestion of the placebo for 4 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) Male and female workers from 30 to 60 years old.
(2) POMS-S FI T score is 50 and more, and VA T score is 50 and less.
Key exclusion criteria
(1) Subjects who routinely use food or medicine containing of DHMBA or oyster meat extract.
(2) Subjects who perform an act for the improvement of the fatigue, the quality of the sleep and stress.
(3) Subjects who wake after sleep onset for nocturia.
(4) Night and day shift worker or manual laborer.
(5) Subjects who have a disease on treatment or are judged to that medical treatment are necessary by the doctor.
(6) Subjects who are under treatment or a history of sleep apnea syndrome or are strongly suspected of having sleep apnea syndrome.
(7) Subjects diagnosed with chronic fatigue syndrome.
(8) Subjects who were under treatment or have a history of serious diseases (e.g., diabetes, liver disease, kidney disease, or heart disease).
(9) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire and other questionnaires.
(10) Those who can not carry out the procedures of various tests to be carried out during this study.
(11) Subjects having possibilities for emerging allergy related to the study.
(12) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination.
(13) 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.
(14) Subjects who are planned to become pregnant after informed consent for the current study
or are pregnant or lactating.
(15) Subjects who are judged as unsuitable for the study by the investigator for other reason.
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Emiko Miki |
Organization
Watanabe Oyster Laboratory, Co., Ltd.
Division name
Scientific Department
Zip code
Address
490-3, Shimoongata-Cho, Hachioji-City, Tokyo
TEL
042-651-8118
gakujutsu@oyster.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Yamamichi |
Organization
TTC Co.,Ltd
Division name
Clinical Research Planning Department
Zip code
Address
Seibu Shinkin Bank Ebisu Bldg.,1-20-2, Ebisunishi, Shibuya-ku, Tokyo
TEL
03-5459-5329
Homepage URL
s.yamamichi@ttc-tokyo.co.jp
Sponsor or person
Institute
TTC Co., Ltd.
Institute
Department
Personal name
Funding Source
Organization
Watanabe Oyster Laboratory, 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
| 2017 | Year | 05 | Month | 12 | 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
| 2017 | Year | 04 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 05 | Month | 13 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2017 | Year | 05 | Month | 12 | Day |
Last modified on
| 2017 | Year | 10 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031314
