Healthy volunteers
Conditions
Interventions
Test food (1 cake (20g)/day) for 14 days >
14-day washout period >
control food (1 cake (20g)/day) for 14 days for 14 days
Control food (1 cake (20g)/day) for 14 days >
test food (1 cake (20g)/day) for 14 days for 14 days
Sponsors
Kanagawa Insutitute of Industrial Sciense and Technology
Linking Setouchi Innate immune Network/ Control of innate immunity TRA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. Healthy volunteers 20 years of age or older at the time of obtaining consent whose blood test values at the time of screening are in range shown in the point. ALT(U/L):30-50, AST(U/L):-50, gamma-GT(U/L):-100, ALP(U/L):-499, LD(U/L):-280, T-Bil(mg/dL):-2.9, RBC(10^4/microL):male 400-599, female 360-549, Hb(g/dL):male 13.1-17.9, female 12.1-15.9, Ht(%):male 38.5-50.9, female 35.5-47.9, Cre(mg/dL):male -1.09, female -0.79, T-cho(mg/dL):140-219, TG(mg/dL): 30-199, LDL-Cho(mg/dL): 60-133, HDL-Cho(mg/dL): 40-119, FPG(mg/dL):-109, HbA1c(%): -5.9
Exclusion criteria
Exclusion criteria: Volunteers whose blood test values (FPG, Hb1Ac, T-cho, TG, LDL-cho, HDL-cho, CRE, RBC, Hb, Ht) at the time of screening are in decision criteria C(follow-up), D1(requires further testing) or D2(requires treatment) of Japan Society of Ningen Dock. Volunteers whose blood test values (ALT, AST,gamma-GT, ALP, LD, T-Bil) at the time of screening are in decision criteria D1(requires further testing) or D2(requires treatment) of Japan Society of Ningen Dock. Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine. Volunteers with a risk of causing drug or food (especially yam and wheat) allergic symptoms. Volunteers taking drugs and supplements which affect the study. Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial. Volunteers have donated blood more than 400mL within the last three months or more than 200mL within the last one month before the date of consent. Volunteers with any other medical reasons judged to be inappropriate by chief investigater.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function (ALT, AST, gamma-GT, ALP, LD, T-Bil) | — |
Secondary
| Measure | Time frame |
|---|---|
| Blood RNA analysis, Fecal (intestinal) mocroflora analysis, Multimodal homeostasis evaluation systems | — |
Countries
Japan
Contacts
Public ContactSHINOZAKI Fumika
Kanagawa Insutitute of Industrial Sciense and Technology Group for Food Functionality Assessment
Outcome results
None listed