The pilot study of effects of food containing plant constituents.
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000021666
- Lead Sponsor
- Suntory Global Innovation Center Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 24
Not provided
1) Subjects whose systolic blood pressure is less than 90 mmHg. 2) Females who are pregnant or lactating, and females who could become pregnant or lactating during test period. 3) Subjects who donated 200 mL of blood and/or blood components within four weeks prior to the current study. 4) Males whose blood was collected more than 400 mL within the last twelve weeks. 5) Females whose blood was collected more than 400 mL within the last twelve weeks. 6) Subjects who are participating in other clinical studies for drug medicine or food, or who finished clinical study within four weeks. 7) Subject who are applicable to one of the below. a) Subject who are contracting heart, liver or kidney disease including the case of complicating disease. b) Subjects with a previous history of cardiovascular disease. c) Subjects who are contracting diabetes. d) Subjects who have allergy to test food. 8) Males whose blood was collected more than 1200 mL within the last twelve months when the amount of blood sampling in the current study is added. 9) Females whose blood was collected more than 800 mL within the last twelve months when the amount of blood sampling in the current study is added. 10) Subjects who underwent abdominal surgical operation within 6 month before test start. 11) Subjects who took antibiotics for 1 month or more within 6 month before test start. 12) Subjects who have an irregular sleep cycle, work shift or work on midnight shift. 13) Subjects who constantly use supplements and/or functional foods (including Food for Specified Health Uses, Foods with Function Claims). 14) Subjects who plan big change of lifestyle during test period. 15) Subjects with tendency of chronic diarrhea. 16) Subjects who considered unfitness for the test because of having previous and/or current medical history of serious disease of liver, kidney and heart. 17) Subjects who suspected chronic or acute infectious disease.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method intestinal microflora
- Secondary Outcome Measures
Name Time Method