Unique ID issued by UMIN | UMIN000021452 |
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Receipt number | R000024651 |
Scientific Title | A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Improve Lipid Metabolism |
Date of disclosure of the study information | 2016/03/17 |
Last modified on | 2017/01/06 15:54:46 |
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Improve Lipid Metabolism
Beneficial Effects of GreenTea Containing Polyphenol on Lipid Metabolism
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Improve Lipid Metabolism
Beneficial Effects of GreenTea Containing Polyphenol on Lipid Metabolism
Japan |
Healthy adults
Adult |
Others
NO
To prove clinical benefits associated with daily ingestion of green tea containing polyphenol or 12 weeks on lipid metabolism.
Efficacy
Confirmatory
Pragmatic
Not applicable
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.
TC, HDL-C, TG, NEFA, phospholipid, ApoB, ApoAI, ApoB/ApoAI ratio, fasting blood glucose, HbA1c, body composition (BW, BFR, BMI)
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
Institution is not considered as adjustment factor.
YES
No need to know
2
Treatment
Food |
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.
20 | years-old | <= |
70 | years-old | > |
Male and Female
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.
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.
90
1st name | |
Middle name | |
Last name | Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun NISHIHIRA, M.D., Ph.D. |
Hokkaido Information University
Center of Health Information Science
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
The Ethics Committee approves that the source of funding shall not be disclosed.
Profit organization
Japan
NO
北海道情報大学 保健センター(北海道)
2016 | Year | 03 | Month | 17 | Day |
Unpublished
Completed
2016 | Year | 01 | Month | 29 | Day |
2016 | Year | 03 | Month | 17 | Day |
2016 | Year | 08 | Month | 13 | Day |
2016 | Year | 09 | Month | 21 | Day |
2016 | Year | 09 | Month | 30 | Day |
2016 | Year | 12 | Month | 22 | Day |
2016 | Year | 03 | Month | 12 | Day |
2017 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024651
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