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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027330
Receipt No. 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

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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
Email 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
Email s.yamamichi@ttc-tokyo.co.jp

Sponsor
Institute TTC Co., Ltd.
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031314

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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