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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000027093
Receipt No. R000031055
Scientific Title Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Date of disclosure of the study information 2017/04/21
Last modified on 2017/10/07

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Basic information
Public title Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Acronym Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Scientific Title Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Scientific Title:Acronym Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
Region
Japan

Condition
Condition Healthy adult
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the safety of excessive consumption of Watanabe Oyster DHMBA Jelly, 3-fold quantity of recommended daily intake.
Basic objectives2 Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Hematologic test
Blood biochemistry test
Urine analysis
Blood pressure/pulsation
Weight/ body mass index
Doctor's questions
Adverse event
Evaluate at points of 2-week and 4-week of consumption and 2 weeks after the end of consumption period.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Food
Interventions/Control_1 Ingestion of the test product for 4 weeks
Interventions/Control_2
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
64 years-old >=
Gender Male and Female
Key inclusion criteria Healthy adult males and females from 20 to 64 years of age
Key exclusion criteria (1) Subjects who routinely use health food richly containing DHMBA or oyster meat extract
(2) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(3) Subjects having possibilities for emerging allergy related to the study
(4) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required
(5) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination
(6) Subjects who have participated in other clinical studies
(7) Subjects who intend to become pregnant or lactating
(8) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire
(9) Subjects judged as unsuitable for the study by the investigator for other reasons
Target sample size 11

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 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
Email h.shimada@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 04 Month 21 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 13 Day
Date of IRB
Anticipated trial start date
2017 Year 04 Month 22 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 04 Month 21 Day
Last modified on
2017 Year 10 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031055

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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