Unique ID issued by UMIN | UMIN000020824 |
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Receipt number | R000023987 |
Scientific Title | A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Reduce Body Fat Percentage |
Date of disclosure of the study information | 2016/02/10 |
Last modified on | 2017/01/06 15:57:46 |
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Reduce Body Fat Percentage
Beneficial Effects of GreenTea Containing Polyphenol on BFP
A Double-Blind, Placebo-Controlled, Parallel Group Comparison Study on Effects of Daily Ingestion of Green Tea Containing Polyphenol to Reduce Body Fat Percentage
Beneficial Effects of GreenTea Containing Polyphenol on BFP
Japan |
Healthy adults
Adult |
Others
NO
To prove clinical benefits associated with ingestion of green tea containing polyphenol daily for 12 weeks on BFP.
Efficacy
Confirmatory
Pragmatic
Not applicable
Area of abdominal visceral fat at 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.
Body composition (BW, BFP, BMI), area of abdominal fat and abdominal subcutaneous fat, waist and hip, and waist-hip ratio
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 |
Ingestion of 4.0 g of green tea containing 100 mg polyphenol daily for 12 weeks.
Ingestion of 4.0 g of green tea daily for 12 weeks.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1. Subjects whose BMI is >=23.0 kg/m2 and <30.0 kg/m2.
2. Subjects who agree to participate in the current study with a written informed consent.
1.Subjects who are under treatment and medication for obese, 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 use pacemaker or defibrillator.
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 physical condition.
8.Subjects who are at risk of having allergic reactions to drugs or foods (especially tea).
9.Subjects who have largely changed their dietary habits, physical activity habits and/or BW within the last 6 months.
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 (EPA, DHA, MCT, phytosterol, sesamin, turmeric, polyphenols and dietary fiber such as indigestible dextrin, etc.) which would affect the blood lipid levels.
12.Subjects who regularly take drugs, functional foods and/or supplements (containing dietary fiber such as indigestible dextrin, polyphenol, etc.) which would affect blood glucose.
13. Heavy smokers, alcohol addicts or subjects with irregular lifestyle
14. 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.
15. Pregnant or lactating women or women expect to be pregnant during the clinical trial.
16. Subjects who participate in other clinical trials within the last one month prior to this study.
17. Any other medical reasons judged by the principal investigator.
190
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 | 02 | Month | 10 | Day |
Unpublished
Completed
2016 | Year | 01 | Month | 29 | Day |
2016 | Year | 02 | Month | 17 | Day |
2016 | Year | 07 | Month | 13 | Day |
2016 | Year | 10 | Month | 31 | Day |
2016 | Year | 11 | Month | 07 | Day |
2016 | Year | 12 | Month | 22 | Day |
2016 | Year | 02 | Month | 01 | Day |
2017 | Year | 01 | Month | 06 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023987
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