Safety evaluation of excessive intake of food containing plant extract for healthy adults.
- Conditions
- Healthy adult
- Registration Number
- JPRN-UMIN000042646
- Lead Sponsor
- TTC Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
(1) Subjects who constantly use health food or medicine richly containing involvement ingredient (2) Subjects routinely taking medicine or health food which may influence bowel movement. (3) Subjects having a large amount of foods which may influence bowel movement such as food containing dietary fiber and lactic acid bacteria. (4) Subjects visiting the hospital for diseases related bowel movements and using drugs, or using commercial laxative. (5) Subjects having diseases or a history of drug addiction or alcoholism. (6) Subjects who are under treatment or have a history of serious disease (e.g., diabetes, liver disease, kidney disease, or heart disease). (7) Subjects having possibilities for emerging allergy related to the study. (8) Subjects who are under medication or having a history of serious diseases for which medication was required. (9) Subjects who are judged as unsuitable for the study based on the results of clinical and physical examination on preliminary examination. (10) Subjects who have participated in other clinical study within the last one month prior to the current study or are planned to participate in other clinical study after informed consent for the current study. (11) Subjects who are planned to become pregnant after informed consent for the current study or are pregnant or lactating. (12) Subjects who are judged as unsuitable for the study based on the results of lifestyle questionnaire. (13) 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/BMI Doctor's questions Adverse event Stool output, defecation frequency, defecation days, fecal condition
- Secondary Outcome Measures
Name Time Method