Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design.
- Conditions
- Healthy subjects
- Registration Number
- JPRN-UMIN000020271
- Lead Sponsor
- ew Drug Research Center, Inc.
- Brief Summary
The results suggest that the excessive consumption of test food is safe in healthy subjects.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 30
Not provided
1) individual with liver, kidney and heart disease, or disorder of respiration, endocrine, metabolism, nervous system, consciousness, or diabetes, or other diseases, 2) individual given surgery within 2 months before the trial, 3) medicine user for hyperglycaemia, lipidemia, or hypertension, 4) individual intakes supplements or the food for specific use of health authorized the government, 5) individual experienced unpleasant feeling during blood drawing, 6) individual donated 200 mL or more blood within 1 month before the trial, 7) individual changed his/her weight 2 kg or more within 1 month before the trial, 8) shiftworker, 9) individual plans bussiness trip for 10 consecutive days or more, 10) individual had allergy against any constituents in the test diet, 11) individual can not conform to alcohol limitation, 12) individual can not conform to record of daily life in a format, 13) individual can not conform to record of daily diet for 9 days (3 days x 3 times), 14) individual cannot allow operator to consult his/her data of the past health check, 15) individual have already participated other clinical trial and will participate, 16) individual cannot accept content of this trial, 17) pregnant women or breast-feeding women, 18) individual who was judged ineligibles by clinician in this trial
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method frequency of adverse events at 4 weeks after intervention.
- Secondary Outcome Measures
Name Time Method