Healthy volunteers
Conditions
Interventions
Test food (1 pack(15mL)/day) for 14 days >
14-day washout period >
control food (1 pack(15mL)/day) for 14 days for 14 days
Control food (1 pack(15mL)/day) for 14 days >
test food(1 pack(15mL)/day) for 14 days for 14 days
Sponsors
Niigata Bio-Research Park, Inc
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Body mass index (BMI): from 23 to less than 30. 2.ALT: 26U/L or more in men, 18U/L or more in women. 3.Volunteers being able to make self-judgent to particupate in this study and giving written informed consent. 4.Volunteers having screening test results judged to be appropriate for this study by investigator.
Exclusion criteria
Exclusion criteria: 1.Patients with dyslipidemia or with diabetes under medical treatment or on the use of medicine. 2.Volunteers having severe history of the diseases (liver, kidney, hert, blood) judged to be inappropriate for this study. 3.Patients with liver diseases of alcoholic steatohepatitis, hepatitis C, hepatitis B, autoimmune hepatitis, cirrhosis, or liver cancer, etc. other than non-alcoholic fatty disease. 4.Volunteers received gastrectomy, enterectomy, or gastro-intestinal diseases, judged to be inappropriate for this study. 5.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms. 6.Volunteers with a risk of causing drug or food (especially maple syrup) allergic symptoms. 7.Women who are pregnant, might be pregnant, or are lactating. 8.Volunteers who participate in other clinical trials within the last one month prior to the current clinical trial. 9.Volunteers with any other medical reasons judged to be inappropriate by chief investigater. 10.Volunteers who habitually consume maple syrup.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Liver function (ALT,AST,gammaGT,ALP,LD,T-Bil) | — |
Secondary
| Measure | Time frame |
|---|---|
| ?Blood RNA analysis ?Fecal (intestinal) mocroflora analysis | — |
Countries
Japan
Outcome results
None listed