Healthy volunteer
Conditions
Interventions
Take a test food (low dose) (12 weeks)
Take a test food (medium dose) (12 weeks)
Take the test food (high dose) (12 weeks)
Take the control food (12 weeks)
Sponsors
Mycology Techno CORP.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: [1]Japanese males and females aged 40-65 years [2]Individuals who are healthy and are not received treatment of disease [3]Individuals whose BMI is 23 to 30kg/m2 [4]Individuals whose written informed consent has been obtained [5]Individuals who can come to the designated examination date and receive the examination [6]Individuals judged appropriate for the study by the principal
Exclusion criteria
Exclusion criteria: [1]Individuals using medical products [2]Individuals under treatment or with history of mental disorders, sleep disorders, hypertension, diabetes, lipid metabolism abnormality, or other serious disorders [3]Individuals receiving/received medical drug treatment for the past 1 month except for temporary relief medication for headache, menstrual pain, common cold, etc. [4]Individuals with history of serious diseases (hepatic, renal, cardiovascular, respiratory, hematologic, etc.) [5]Individuals with history of gastrointestinal disorders except for appendicitis [6]Individuals who donated blood over 200mL in the past 1 month or over 400mL in the past 3 months [7]Individuals who have experienced mood disorder or condition deterioration due to blood sampling in the past [8]Individuals with serious anemia [9]Individuals deemed sensitive to the test product or highly allergic to foods or medical drugs [10]Individuals who excessively take alcohol (expressed in an amount of alcohol: over 40mg/day) [11]Individuals whose number of smokers exceeds 20 on average per day [12]Individuals whose life style will change during the test period (ex. travel for a long time) [13]Individuals who are pregnant or are posslibly, or are lactating [14]Individuals who participated in other clinical studies in the past three months [15]Individual with potential conflict of interest [16]Individuals judged inappropriate for the study by the principal
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ChE(6W,12W), TG(6W,12W) | — |
Secondary
| Measure | Time frame |
|---|---|
| AST,ALT,Gamma-GT,ALP,LDH,T-cho,LDL-cho,HDL-cho(6W,12W) | — |
Countries
Japan
Contacts
Public ContactTatsuya Honda
DRC Co.,Ltd. Product Testing & Studies Division
Outcome results
None listed