Safety confirmation studies of excessive intake of food including black vinegar in adult men and wome
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000027042
- Lead Sponsor
- TTC Co.,Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
(1) Subjects who routinely use health food including functional substance richly (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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method