Unique ID issued by UMIN | UMIN000012507 |
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Receipt number | R000014570 |
Scientific Title | Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia |
Date of disclosure of the study information | 2013/12/06 |
Last modified on | 2014/04/02 14:41:37 |
Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia
Effect of rutin-rich buckwheat on dyslipidemia
Double-blind, placebo-controlled study for the effect of rutin-rich processed buckwheat (Manten-kirari) on dyslipidemia
Effect of rutin-rich buckwheat on dyslipidemia
Japan |
dyslipidemia
Endocrinology and Metabolism |
Others
NO
The purpose is to evaluate the effect of rutin-rich buckwheat(Manten-kirari) on dyslipidemia by Double-blind, placebo-controlled study
Safety,Efficacy
Confirmatory
Pragmatic
Phase III
LDL-CHO, adiponectin, visceral fat area
T-CHO, HDL-CHO, TG, fasting blood glucose, HbA1c, RLP-CHO, leptin, oxo-LDL, TBARS, hs-CRP, IL-6, TNF-alfa,CAVI and ABI score, FMD, blood pressure
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
3
Treatment
Food |
Intake 80g of rehydratable noodle containing 50% rutin-rich buckwheat powder daily for 8 weeks.
Intake 80g of rehydratable noodle containing 5% rutin-rich buckwheat powder daily for 8 weeks.
Intake 80g rehydratable noodle lack of rutin-rich buckwheat powder daily for 8 weeks.
30 | years-old | <= |
70 | years-old | > |
Male and Female
(1)Subjects whose serum LDL cholesterol levels are between 120mg/dl and 180mg/dl.
(2)Subjects who agree to participate in the current study with written informed consent.
(1)Subjects who are under medication for chronic ailments.
(2)Subjects with serious diseases and infections.
(3)Subjects with clinical history of gastrointestinal surgery.
(4)Subjects with frequent complaints of post-menopausal symptoms.
(5)Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
(6)Subjects with serious anemia.
(7)Subjects with a history of allergy to medicine and food, especially buckwheat and wheat.
(8)Subjects routinely on supplementation which would affect the lipid metabolism.
(9)Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
(10)Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
(11)Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
(12)Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
(13)Subjects who are not eligible due to physician's judgment
66
1st name | |
Middle name | |
Last name | Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Department of Medical Management and Informatics
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
011-385-4411
nishihira@do-johodai.ac.jp
1st name | |
Middle name | |
Last name | Dir. Prof. Jun Nishihira, M.D. |
Hokkaido Information University
Health Information Science Center
59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
Ministry of Agriculture, Forestry and Fisheries
Japan
Hokkaido university faculty
of agriculture
National Agriculture and Food
Research Organization for Hokkaido
Region
Kobayashi Foods co, Ltd.
NO
北海道情報大学 保健センター(北海道)
2013 | Year | 12 | Month | 06 | Day |
Unpublished
Completed
2013 | Year | 11 | Month | 28 | Day |
2013 | Year | 11 | Month | 28 | Day |
2014 | Year | 03 | Month | 17 | Day |
2013 | Year | 12 | Month | 06 | Day |
2014 | Year | 04 | Month | 02 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014570
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