Unique ID issued by UMIN | UMIN000036276 |
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Receipt number | R000041310 |
Scientific Title | Effect of Daily Ingestion of Quercetin-Rich Onion on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study |
Date of disclosure of the study information | 2019/04/05 |
Last modified on | 2020/03/18 17:46:01 |
Effect of Daily Ingestion of Quercetin-Rich Onion on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Beneficial Effects of Quercetin-Rich Onion on Cognitive function
Effect of Daily Ingestion of Quercetin-Rich Onion on Cognitive function: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study
Beneficial Effects of Quercetin-Rich Onion on Cognitive function
Japan |
Healthy adults
Adult |
Others
NO
To investigate clinical benefits associated with 24 week daily ingestion of the processed food of quercetin-rich onion on cognitive function in a randomized, double-blind, placebo-controlled, parallel group study.
Safety,Efficacy
Pragmatic
MMSE at 24 weeks after beginning the ingestion of test food.
Cognitive function evaluation (CADi2 iPad version), emotion function evaluation (CADi2 iPad version), word recall test, NPI-NH, TC, HDL-C, LDL-C, TG, glucose, HbA1c, serum quercetin
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
Central registration
2
Treatment
Food |
Daily ingestion 11 g of quercetin-rich onion powder for 24 weeks.
Daily ingestion 11 g of quercetin-free onion powder for 24 weeks.
60 | years-old | <= |
80 | years-old | > |
Male and Female
1.Subjects who fully understand significance, content and purpose of this study and who agree to participate in this study with a written informed consent.
2.Subjects who can carry out cognitive function test, write diary and questionnaire.
3.Subject with a study partner.
1.Subjects whose MMSE score is <= 23 points.
2.Subjects who are under medication for dementia, Alzheimer's disease, psychiatric disorder and cerebrovascular disease.
3.Subjects with a history of (or suspected) psychiatric disorder and cerebrovascular disease.
4.Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
5.Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
6.Subjects with unusually high and/or low blood pressure and/or abnormal physical data and hematological data.
7.Subjects with severe anemia.
8.Pre- or post-menopausal women complaining of obvious physical changes.
9.Subjects who are at risk of having allergic reactions to drugs or foods especially based on onion.
10.Subjects who regularly take medicine, functional foods, and/or supplements which would affect cognitive function.
11.Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
12.Subjects who donated either 400 ml whole blood within 16 weeks (women), 12 weeks (men), 200 ml whole blood within 4 weeks (men and women), or blood components within 2 weeks (men and women), prior to the current study.
13.Subjects who currently participate in other clinical trials, or participated within the last 4 weeks prior to the current study.
14.Any other medical and/or health reasons unfavorable to participation in the current study, as judged by the principal investigator.
56
1st name | Jun |
Middle name | |
Last name | NISHIHIRA |
Hokkaido Information University
Department of Medical Management and Informatics
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
nishihira@do-johodai.ac.jp
1st name | Jun |
Middle name | |
Last name | NISHIHIRA |
Hokkaido Information University
Health Information Science Center
069-8585
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4430
nishihira@do-johodai.ac.jp
Hokkaido Information University
NARO Bio-oriented Technology Research Advancement Institution
Japanese Governmental office
Japan
1. Food Research Institute, NARO
2. Tohoku Agricultural Research Center, NARO
The ethics committee of Hokkaido Information University
59-2, Nishi-nopporo, Ebetsu, Hokkaido, 069-8585, Japan
011-385-4411
soumu@do-johodai.ac.jp
NO
北海道情報大学 保健センター(北海道)
2019 | Year | 04 | Month | 05 | Day |
Unpublished
Completed
2019 | Year | 02 | Month | 26 | Day |
2019 | Year | 02 | Month | 26 | Day |
2019 | Year | 04 | Month | 06 | Day |
2019 | Year | 12 | Month | 04 | Day |
2020 | Year | 02 | Month | 04 | Day |
2020 | Year | 02 | Month | 11 | Day |
2020 | Year | 03 | Month | 31 | Day |
2019 | Year | 03 | Month | 22 | Day |
2020 | Year | 03 | Month | 18 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041310
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