A study to evaluate the effects of test food on reducing body fat
- Conditions
- Healthy volunteers
- Registration Number
- JPRN-UMIN000048430
- Lead Sponsor
- ROHTO Pharmaceutical Co.,Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 80
Not provided
1) Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 2) Subjects receiving a medical treatment for chronic diseases (dyslipidemia, high blood pressure, diabetes, etc.) 3) Subject who have mental diseases such as depression, schizophrenia and bulimia nervosa. 4) Subjects who take regularly medicines and quasi-drugs having the effects on visceral fat, triglycerides, body weight, cholesterol, energy metabolism, etc. 5) Subjects who take regularly health food (Food for Specified Health Uses, Food with Functional Claims, etc.) having the effects on visceral fat, triglycerides, body weight, cholesterol, energy metabolism, etc. 6) Subjects who have the possibility of developing allergic symptoms by the test food 7) Subjects who have metallic device in the abdominal CT scan area 8) Subjects who have implantable medical device (cardiac pacemaker, implantable cardioverter defibrillator, etc.) 9) Subjects who have claustrophobia 10) Subjects who have smoking habit 11) Subjects who routinely drink a lot (60 g/day or more as pure alcohol) 12) Subjects who have an extremely irregular diet habit 13) Subjects who are alternative workers, or work on midnight shift 14) Subjects having blood sample of 200 ml or more taken within 1 month, or 400 ml or more within 3 months prior to the start of the present study (e.g. donated blood) 15) Subjects who took part in another clinical study within 4 months prior to the start of the present study or who is currently taking part in another clinical study 16) Subjects who are pregnant or lactating, or intending to become pregnant during the study 17) Subjects deemed unsuitable by the investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method visceral fat area
- Secondary Outcome Measures
Name Time Method body weight, BMI, subcutaneous fat area, total fat area, body fat percentage, body fat mass, muscle mass, body fat mass (upper limbs, lower limbs, trunk), basal metabolic rate, waist circumference, hip circumference, waist to hip ratio, VAS (fatigue sensation), OSA sleep inventory MA version, ketone bodies, total cholesterol, LDL cholesterol, HDL cholesterol, triglycerides, glucose, HbA1c, insulin, glycoalbumin