Healthy volunteers
Conditions
Interventions
Intake of test food for 12 weeks
Intake of placebo for 12 weeks
Sponsors
ROHTO Pharmaceutical Co.,Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Males and females whose age of 20 years or more and less than 65 years 2) Subjects whose BMI is 23.0 kg/m2 or more and less than 30.0 kg/m2 3) Subjects whose visceral fat area is 100 cm2 or more 4) Subjects receiving a sufficient briefing of the objective and content of the present study, fully understanding and agreeing to voluntarily participate in the study and being able to personally sign a written informed consent
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visceral fat area | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
Japan
Contacts
Public ContactTomohiro Sugino
Soiken Inc. R&D Division
Outcome results
None listed