Safety evaluation of the consumption of plant-derived processed product in healthy adults: a double-blind, randomized controlled trial with parallel group design. - Safety evaluation of plant-derived processed product

ew Drug Research Center, Inc.0 个研究点目标入组 30 人开始时间: 2016年1月20日最近更新: 2023年10月17日

适应症

试验速览

The results suggest that the excessive consumption of test food is safe in healthy subjects.

•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

发起方

ew Drug Research Center, Inc.