Safety evaluation of a single intake of a test food containing Plant extract
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000048998
- Lead Sponsor
- FANCL Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 10
Not provided
1. Subjects with a serious medical history and those suffering from hepatic disorder, renal or cardiac disease, organ failure, diabetes mellitus, or other serious diseases 2. Subjects with a history of gastrointestinal resection (except for appendicectomy) 3. Subjects with chronic diseases under treatment 4. Subjects who are at risk of developing an allergy in relation to the study 5. Subjects who are aware that the frequency of defecation or stool characteristics may easily change significantly as gastrointestinal symptoms. 6. Heavy drinkers of alcohol (>60 g/day of pure alcohol) or excessive smokers (>20 cigarettes/day) or smokers who cannot quit smoking during the study under unified control. 7. Pregnant or planning to become pregnant or breastfeeding during the study period 8. Subjects who work late at night, work overtime for a long period of time, or work the irregular shifts 9. Subjects who are participating in other study in which test foods or drugs are taken, or in which cosmetics or drugs are applied, or who plan to participate in other study during the study period. 10. Subjects who may need to avoid consuming the food or beverage used in the study with religious or other reasons, since the origin of the ingredients are not specified. 11. Those who are judged to be unsuitable as subjects based on the results of the background survey. 12. Subjects whose physical or clinical examination data prior to the start of intake are significantly out of the reference range. 13. Subjects who are judged to be inappropriate to participate in this study by the investigator.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Subjective symptoms, physician's examination findings, physical examination, clinical examination
- Secondary Outcome Measures
Name Time Method