Unique ID issued by UMIN | UMIN000020959 |
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Receipt number | R000024183 |
Scientific Title | A Double-Blind, Placebo-Controlled, Cross-over Study on Effects of the single intake of Azuki (Vigna angularis) Polyphenol to improve postprandial serum triglyceride. |
Date of disclosure of the study information | 2016/02/10 |
Last modified on | 2016/11/24 15:37:09 |
A Double-Blind, Placebo-Controlled, Cross-over Study on Effects of the single intake of Azuki (Vigna angularis) Polyphenol to improve postprandial serum triglyceride.
Beneficial Effects of Azuki Polyphenol on postprandial serum triglyceride
A Double-Blind, Placebo-Controlled, Cross-over Study on Effects of the single intake of Azuki (Vigna angularis) Polyphenol to improve postprandial serum triglyceride.
Beneficial Effects of Azuki Polyphenol on postprandial serum triglyceride
Japan |
Healthy adults
Not applicable | Adult |
Others
NO
To prove clinical benefits associated with single intake of azuki polyphenol on postprandial serum triglyceride.
Efficacy
Pragmatic
Not applicable
Area under the curve of TG
NEFA,RLP-Cho, phospholipid, blood glucose, insulin
Interventional
Cross-over
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 |
Intake the capsule containing azuki polyphenol once with fatty meal, and take wash out period for 1 week, and then, intake the placebo capsule once with fatty meal.
Intake the placebo capsule once with fatty meal, and take wash out period for 1 week, and then, intake the capsule containing azuki polyphenol once with fatty meal.
20 | years-old | <= |
65 | years-old | > |
Male and Female
1.Subjects who have relatively high postprandial serum triglyceride.
2.Subjects who agree to participate in the current study with a written informed consent.
1.Subjects who are under treatment
and medication for hyperlipidemia and diabetes.
2.Subjects whose fasting serum triglyceride is >=200mg/dl.
3.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.
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 azuki, gelatin
pork, chicken, milk, soybean,
Wheat ).
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
20
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
NOASTEC foundation
Non profit foundation
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 | 12 | Day |
2016 | Year | 03 | Month | 16 | Day |
2016 | Year | 04 | Month | 29 | Day |
2016 | Year | 05 | Month | 06 | Day |
2016 | Year | 11 | Month | 17 | Day |
2016 | Year | 02 | Month | 09 | Day |
2016 | Year | 11 | Month | 24 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024183
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