Healthy adults
Conditions
Interventions
Ingestion of the Mulberry Leaf Tea daily for 8 weeks
Ingestion of the placebo tea daily for 8 weeks
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male subjects whose ALT is more than 26U/I, female subjects whose ALT is more than 18U/l. 2. Subjects whose BMI is between 23 and 30. 3. Subjects who agree to participate in the current study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under treatment and medication for hyperlipidemia, and diabetes. 2. Subjects with serious cerebrovascular, cardiac, hepatic, renal, and / or gastrointestinal diseases, or affected with an infectious disease which is required to report to the authorities 3. Subjects with liver disease except for NAFLD. 4. Subjects who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 5. Subjects with unusually high and/or low blood pressure or abnormal hematological data 6. Subjects with serious anemia 7. Pre- or post-menopausal subjects having complaints of obvious physical changes 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially Mulberry leaf, brown rice and/or spinach ) 9. Subjects regularly take medicine , functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols, and/or dietary fiber, etc.) which would affect the blood lipids. 10. Subjects regularly take medicine functional foods and/or supplements based on dietary fiber from resistant dextrin, and/or polyphenols, etc. which would affect the blood glucose. 11. Heavy smokers, alcohol addicts or subjects with irregular lifestyle 12. Subjects who donate either 400ml whole blood within 12 weeks or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 13. Subjects who are pregnant or expected to be pregnant, or lactating during the study 14. Subjects who participate in other clinical trials within the last one month prior to the current clinical trial 15. Any other medical reasons judged by the principal investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| ALT | — |
Secondary
| Measure | Time frame |
|---|---|
| AST, gamma GTP,ALP,LDH,T-Cho, HDL-Cho, LDL-Cho, TG, NEFA, TP, Alb, T-Bil, A/G ratio, fasting plasma glucose, HbA1c, Insulin, blood RNA, fecal intestinal bacterial flora, body weight, body fat rate, BMI, VAS questionnaire, NAFLD fibrosis score | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Center of Health Information Science
Outcome results
None listed