None listed
Conditions
Interventions
Sponsors
KSO Corporation
TOYO SHINYAKU Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1)Healthy males and females aged 20 to 64 years-old. (2)Subjects whose BMI are 23 or over and under 30. (3)Subjects who can make self-judgment and are voluntarily giving written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who 1)use habitually medications. 2)contract serious diseases (eg, liver disease, kidney disease, digestive disease, heart disease, respiratory disease, endocrine disease, thyroid disease, adrenal disease and/or metabolic disease). 3)have implantable medical devices (e.g., cardiac pacemaker and/or implantable defibrillator). 4)have been implanted metal in the abdominal area, as detected by computerized tomography. 5)have claustrophobia. 6)have declared allergic reaction to ingredients of test foods. 7)have a history and/or a surgical history of digestive disease affecting digestion and absorption. 8)can't stop using supplements and/or functional foods (including Food for Specified Health Uses or Foods with Function Claims) affecting obesity, hyperlipidemia , lipid metabolism, and so on during test periods. 9)can't stop drinking from 2 days before each measurement. 10)are under treatment for or have a history of drug addiction and/or alcoholism. 11)have been diagnosed as familial hyperlipidemia. 12)have excessive alcohol intake more than 20 g/day of pure alcohol equivalent for more than 4 days a week. 13)are shift worker, midnight-shift worker, and/or subjects with extremely irregular dietary habits. 14)were judged as unsuitable for the current study by screening tests. 15)have donated over 200 mL of blood and/or blood components within the last one month prior to the current study or over 400 mL of blood and/or blood components within the last three months prior to the current study. 16)are pregnant or planning to become pregnant or breastfeed. 17)are planning to participate and/or had participated in other clinical studies within the last one month prior to the current study. 18)are judged as unsuitable for the current study by the investigator for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| visceral fat area Body weight (BMI) | — |
Secondary
| Measure | Time frame |
|---|---|
| Waist circumference | — |
Countries
Japan
Contacts
Public ContactYoshika Komori
KSO Corporation Clinical Trial Management department
Outcome results
None listed