Safety evaluation of an excessive consumption of a grain-derived processed product A001.
- Conditions
- othing(Healthy adults)
- Registration Number
- JPRN-UMIN000023760
- Lead Sponsor
- TES Holdings Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 40
Not provided
1.Person who is difficult to participate the study due to dysfunctions liver, kidney, heart, respiration, endocrine secretion, metabolism, nervous system, consciousness or diabetes, or the other dysfunctions. 2.Person who was given surgery or medication treatment for a disease or an injury 2 months prior to the study. 3.Medicine user for hyperglycaemia, lipidemia, or hypertension. 4.Person who habitually takes the foods for specified health uses (FOSHU) or functional food. (Except for subjects who can stop consume them after informed consent). 5.Person who experienced unpleasant feeling during blood drawing. 6.Person who has donated over 200 mL of blood within the last one month prior to the current study. 7.Person whose weight changes more than 2 kg during past one year. 8.Person who is shift worker 9.Person who plan to go long term business trip or trip (more than 10 consecutive days) during current study. 10.Person who can't intake test meal. 11.Person who has possibility for allergic reaction to any constituents in the test meal. 12.The person who cannot observe a limit of the quantity of drinking (under 20 g/day alcohol) 13.Person who cannot input to 'life diary' (the intake situation, record of the physical condition) every day during the period of the test. 14.Person who can not input to a meal record for 9 days (3 days x 3 times) 15.Person who can't accept to access past medical chart. 16.Person who has participated in other clinical study or are planned to participate in other clinical study. 17.Person who can't agree current informed consent. 18.Woman who is pregnant, breast-feeding, or expecting pregnancy during the period of the test. 19.Person who is judged to be inappropriate for current study based on the medical chart by medical doctor.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Safety evaluation (repeated ingestion for 4 weeks) at before and after 2 and 4 weeks ingestion. anthropometric parameters blood hematology blood biochemical test urine test
- Secondary Outcome Measures
Name Time Method