Healthy adults
Conditions
Interventions
Daily ingestion of 4.0 g of green tea containing 100 mg polyphenol for 12 weeks.
Daily ingestion of 4.0 g of green tea for 12 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Subjects whose LDL-C is >=120.0 mg/dl and <160 mg/dl. 2.Subjects who agree to participate in the current study with a written informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects who are under physician's advice, treatment and/or medication for hyperlipidemia and diabetes. 2. Subjects with serious cerebrovascular, cardiac, hepatic,renal, gastrointestinal diseases, disorder of endocrine and metabolism or affected with infectious diseases which are required to report to the authorities. 3. Subjects with familial hypercholesterolemia. 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 women having obvious changes in physicalcondition. 8. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 9.Subjects who regularly take drugs, functional foods and/or supplements (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols and dietary fiber such as indigestible dextrin, etc.) which would affect the blood lipid levels. 10.Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect 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. Pregnant or lactating women or women expect to be pregnant during the clinical trial. 14. Subjects who participate in other clinical trials within the last one month prior to this study. 15. Any other medical reasons judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Level of LDL-C at 4 weeks, 8 weeks and 12 weeks after the beginning of ingestion of test meals and at 4 weeks after the end of ingestion of test meals. | — |
Secondary
| Measure | Time frame |
|---|---|
| TC, HDL-C, TG, NEFA, phospholipid, ApoB, ApoAI, ApoB/ApoAI ratio, fasting blood glucose, HbA1c, body composition (BW, BFR, BMI) | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Center of Health Information Science
Outcome results
None listed