Healthy adults
Conditions
Interventions
Daily intake of 4 tablet of active test food for 12 weeks.
Daily intake of 4 tablet of placebo food for 12 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects whose ALT level is higher. 2. Subjects whose BMI is higher. 3. Subjects who agree to participate in this study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment, and/or medication for dyslipidemia, diabetes, and/or hyperuricemia. 2. Subjects with serious hepatic diseases. 3. Subjects whose AST level is not less than the reference value. 4. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities. 5. Subjects who use pacemaker or defibrillator. 6. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 7. Subjects with unusually high and/or low blood pressure and/or abnormal hematological data. 8. Subjects with severe anemia. 9. Pre- or post-menopausal women complaining of obvious physical changes. 10. Subjects who are at risk of having allergic reactions to drugs or foods. 11. Subjects who regularly take medicine, functional foods, and/or supplements which would affect liver function. 12. Subjects who regularly take medicine, functional foods, and/or supplements which would affect lipid metabolism. 13. Subjects who regularly take medicine, functional foods, and/or supplements which would affect glucose metabolism. 14. Heavy smokers, alcohol addicts or subjects with eating disordered lifestyle. 15. Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study. 16. Pregnant or lactating women or women who expect to be pregnant during this study. 17. Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study. 18. Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AST, ALT, gamma-GTP, ALP, LDH, ChE, AST/ALT ratio at 4, 8 and 12 weeks after beginning the intake of test food, and L/S ratio at 12 weeks after beginning the intake of test food. | — |
Secondary
| Measure | Time frame |
|---|---|
| FIB-4 index, NAFLD fibrosis score, TP, Alb, A/G ratio, fasting blood glucose, HbA1c, Insulin, HOMA-IR, TC, LDL-C, HDL-C, TG, hs-CRP, adiponectin, leptin, TNF-alpha, IL-1 beta, IL-6, body weight, body fat rate, BMI, VAS questionnaire assessed fatigue and skin condition. | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Health Information Science Research Center
Outcome results
None listed