Healthy adults
Conditions
Interventions
Daily ingestion of 4.0 g (green tea containing 100 mg of polyphenol)x 3 packs for 4 weeks.
Sponsors
Hokkaido Information University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects who meet the following criterion either a, b or c a. Subjects whose LDL-C is >=120 mg/dl and <160 mg/dl and BMI is >=18.5 kg/m2and <30.0 kg/m2. b. Subjects whose LDL-C is >=70 mg/dl and <160 mg/dl and BMI is >=23.0 kg/m2 and <30.0 kg/m2. c. Subjects whose LDL-C is >=70 mg/dl and <120 mg/dl and BMI is >=18.5 kg/m2 and <23.0 kg/m2. 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&#39;s advice, treatment and/or medication for obesity, 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 who have a major surgical history related to digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc. 4. Subjects with unusually high and/or low blood pressure or abnormal hematological data. 5. Subjects with serious anemia. 6. Pre- or post-menopausal women having obvious changes in physical condition. 7. Subjects who are at risk of having allergic reactions to drugs or foods (especially tea). 8. Subjects who have largely changed their dietary habits, physical activity habits and/or BW within the last 6 months. 9. Subjects with familial hypercholesterolemia. 10. Subjects who regularly take drugs, functional foods and/or supplements which would affect BW and BFP. 11. Subjects who regularly take drugs, functional foods and/or supplements which would affect the blood lipid levels. 12. Subjects who regularly take drugs, functional foods and/or supplements which would affect blood glucose. 13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle. 14.Subjects who donated either 400ml whole blood within 12 weeks (men) /16 weeks (women) or 200ml whole blood within 4 weeks or blood components within 2 weeks prior to this study. 15. Pregnant or lactating women or women expect to be pregnant during the clinical trial. 16. Subjects who participated in other clinical trials within the last one month prior to this study. 17. Subjects who have participated in previous clinical trials of ingestion of the same active test food. 18. Any other medical reasons judged by the principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of side effects related to ingestion of the active test food during the administration period and the post administration period. | — |
Secondary
| Measure | Time frame |
|---|---|
| The pattern, severity and frequency of adverse events during the administration period and the post administration period, the body composition (BW, BFP and BMI) and blood lipids (TC, LDL-C, HDL-C, TG, NEFA and phospholipid) | — |
Countries
Japan
Contacts
Public ContactDir. Prof. Jun NISHIHIRA, M.D., Ph.D.
Hokkaido Information University Center of Health Information Science
Outcome results
None listed