Safety evaluation of an excessive consumption of food material - Randomized, double-blind, placebo-controlled parallel group study
- Conditions
- ot applicable
- Registration Number
- JPRN-UMIN000043825
- Lead Sponsor
- Maruzen Pharmaceuticals Co., Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Not provided
1)Subjects who BMI >=30.0 kg/m2 or <18.5 kg/m2 2)Subjects who have systolic blood pressure <90 mmHg 3)Subjects who received medication treatment or surgery due to serious illness or injury within 1 month from the start of this study 4)Subjects who have a history of severe illness and current medical history in the heart, liver, kidney, digestive organs 5)Subjects who regularly use drugs, health foods, and supplements 6)Females in pregnancy, lactation and scheduled pregnancy during test period. 7)Heavy alcoholic beverager(40g alcohol/day>=), heavy smoker(21 cigarettes/day>=) 8)Subjects who feel bad mood by blood collection in past 9)Subjects who donated 200 mL or more of blood within 1 month from the start of the study or subjects who plan to do so during the study period 10)Night shift worker 11)Don't usually have breakfast 12)Subjects who plan business trip or trip for 10 days or more a month 13)Subjects who have allergy related to the study foods 14)Those who have been diagnosed with chronic constipation 15)Dysphagic person 16)Subjects already participating in other clinical trials 17)Subjects who are ineligible due to physician's judgement
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Expression rate of side effect, Expression rate of Adverse event , clinical examination items, physiological examination items
- Secondary Outcome Measures
Name Time Method