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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000028365 |
Receipt No. | R000032472 |
Scientific Title | Safety confirmation studies of excessive intake of food including black sesame and black vinegar in healthy adult men and women |
Date of disclosure of the study information | 2017/07/25 |
Last modified on | 2017/12/07 |
Basic information | ||
Public title | Safety confirmation studies of excessive intake of food including black sesame and black vinegar in healthy adult men and women | |
Acronym | Safety confirmation studies of excessive intake of food including black sesame and black vinegar in healthy adult men and women | |
Scientific Title | Safety confirmation studies of excessive intake of food including black sesame and black vinegar in healthy adult men and women | |
Scientific Title:Acronym | Safety confirmation studies of excessive intake of food including black sesame and black vinegar in healthy adult men and women | |
Region |
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Condition | ||
Condition | Healthy adult | |
Classification by specialty |
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Classification by malignancy | Others | |
Genomic information | NO |
Objectives | |
Narrative objectives1 | To evaluate the safety of excessive intake of food including black sesame and black vinegar 5-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 intake and 2 weeks after the end of ingestion 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 |
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Interventions/Control_1 | Oral intake of the test product 10 grains per day, 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 |
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Age-upper limit |
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Gender | Male and Female | |||
Key inclusion criteria | Healthy adult men and women from 20 to 64 years of age | |||
Key exclusion criteria | (1) Subjects judged as unsuitable for this study based on the results of clinical examination or cardiopulmonary abnormality
(2) Subjects having possibilities for emerging allergy related to the study (3) Subjects having a disease requiring regular medication or a history of serious diseases for which medication was required (4) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination (5) Subjects who have participated in other clinical studies (6) Subjects who intend to become pregnant or lactating (7) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire (8) Subjects judged as unsuitable for the study by the investigator for other reasons |
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Target sample size | 10 |
Research contact person | |||||||
Name of lead principal investigator |
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Organization | Medical Station Clinic | ||||||
Division name | None | ||||||
Zip code | |||||||
Address | 3-12-8 Takabann, Meguro-ku, Tokyo, Japan | ||||||
TEL | 03-6452-2712 | ||||||
info@med-station.jp |
Public contact | |||||||
Name of contact person |
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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.tsuchida@ttc-tokyo.co.jp |
Sponsor | |
Institute | TTC Co., Ltd. |
Institute | |
Department |
Funding Source | |
Organization | Non-disclosure |
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 |
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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 |
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Date of IRB | |||||||
Anticipated trial start date |
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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 |
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Last modified on |
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Link to view the page | |
URL(English) | https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032472 |
Research Plan | |
Registered date | File name |
Research case data specifications | |
Registered date | File name |
Research case data | |
Registered date | File name |