Healthy volunteers
Conditions
Interventions
Intake of test food 1 for twelve weeks (one packet a day)
Intake of test food 2 for twelve weeks (one packet a day)
Intake of placebo for twelve weeks (one packet a day)
Sponsors
Morishita Jintan 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 with a BMI of 25 kg/m2 or more and less than 30 kg/m2 3) 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)Shift workers 2)Subjects with irregular eating habits 3)Subjects exercising for the purpose of weight loss or muscle building 4)Subjects whose exercise habits are likely to change significantly during the examination and subjects who will be relocating, traveling for more than one week during the examination 5)Subjects receiving a medical treatment for serious cardio-vascular, hepatic, renal, respiratory, endocrine or metabolic disorders or having a medical history of these disorders 6)Subjects receiving a medical treatment for chronic diseases such as dyslipidemia, hypertension, and diabetes 7)Subjects diagnosed with chronic constipation 8)Subjects regularly taking medicines and quasi-drugs that may affect the evaluation of this study, such as body fat, triglycerides, body weight, cholesterol, blood glucose, and energy metabolism 9)Subjects regularly taking foods for specified health uses or foods with functional claims that may affect the evaluation of this study, such as body fat, triglycerides, body weight, cholesterol, blood glucose, and energy metabolism 10)Subjects having the possibility of developing allergic symptoms by the test food and prescribed diet 11)Subjects with claustrophobia, subjects with metal in the CT scan measurement site and subjects with implanted medical devices such as cardiac pacemakers, etc. 12)Subjects consuming more than 40 g/day of alcohol for men and 20 g/day for women 13)Subjects smoking excessively (21 or more cigarettes/day) 14)Subjects having a blood draw of 200 mL or more within 1 month prior to study entry or a blood draw of 400 mL or more within 3 months prior to study entry. 15)Subjects who took part in another clinical study within 3 months prior to the start of this study, who are currently taking part in another clinical study, or who plan to participate during this 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 by abdominal CT imaging | — |
Secondary
| Measure | Time frame |
|---|---|
| Subcutaneous and total fat area by abdominal CT imaging, body weight, BMI, body fat mass, body fat percentage, waist circumference, blood glucose, plasma level of active GLP-1, serum levels of insulin and adiponectin | — |
Countries
Japan
Contacts
Public ContactMasaki Wakabayashi
Soiken Inc. R&D Division
Outcome results
None listed