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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-UMIN000027093 |
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Date of registration:
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21/04/2017 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women
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Scientific title:
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Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women - Safety evaluation of excessive intake of food, Watanabe Oyster DHMBA Jelly, in healthy adult men and women |
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Date of first enrolment:
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2017/04/22 |
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Target sample size:
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11 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000031055 |
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Study type:
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Interventional |
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Study design:
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Single arm Non-randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hiroyasu Shimada |
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Address:
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1-20-2, Ebisunishi, Shibuya-ku, Tokyo
Japan |
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Telephone:
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03-5459-5329 |
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Email:
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h.shimada@ttc-tokyo.co.jp |
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Affiliation:
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TTC Co., Ltd. Clinical Research Planning Department |
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Name:
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Emiko Miki |
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Address:
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490-3, Shimoongata-Cho, Hachioji-City, Tokyo
Japan |
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Telephone:
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042-651-8118 |
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Email:
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gakujutsu@oyster.co.jp |
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Affiliation:
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Watanabe Oyster Laboratory, Co., Ltd. Scientific Department |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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
Age minimum:
20years-old
Age maximum:
64years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Healthy adult
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Intervention(s)
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Ingestion of the test product for 4 weeks
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Primary Outcome(s)
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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.
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Source(s) of Monetary Support
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Watanabe Oyster Laboratory, Co., Ltd.
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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