Unique ID issued by UMIN | UMIN000040765 |
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Receipt number | R000046551 |
Scientific Title | Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial) |
Date of disclosure of the study information | 2020/06/15 |
Last modified on | 2021/10/25 09:52:02 |
Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)
Beneficial Effects of Quercetin-Rich Onion on Visceral Fat
Effect of Daily Ingestion of Quercetin-Rich Onion on Visceral Fat for 12 weeks: A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study (Confirmatory Trial)
Beneficial Effects of Quercetin-Rich Onion on Visceral Fat
Japan |
Healthy adults
Adult |
Others
NO
To investigate clinical benefits associated with 12 weeks daily ingestion of the processed food of quercetin-rich onion on visceral fat in a randomized, double-blind, placebo-controlled, parallel group study.
Safety,Efficacy
Confirmatory
Pragmatic
Visceral fat area at 12 weeks after beginning the ingestion of test food.
Total fat area, subcutaneous fat area, liver-to-spleen ratio, body composition (body weight, body mass index, body fat rate, abdominal circumference), liver function (AST, ALT, gamma-GTP, ALP, LDH), oxidized LDL, adiponectin, TNF-alpha, serum quercetin, gut microflora.
Interventional
Parallel
Randomized
Individual
Double blind -all involved are blinded
Placebo
YES
NO
YES
No need to know
2
Treatment
Food |
Daily ingestion 10 g of quercetin-rich onion powder for 12 weeks.
Daily ingestion 10 g of quercetin-free onion powder for 12 weeks.
35 | years-old | <= |
65 | 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 whose BMI is >=23 kg/m2 and <30 kg/m2.
1. Subjects who are under physician's advice, treatment, and/or medication for obese.
2. Pacemaker or defibrillator users.
3. Subjects with serious cerebrovascular, cardiac, hepatic, renal, gastrointestinal diseases, and/or affected with infectious diseases requiring reports to the authorities.
4. Subjects with major surgical history relevant to the digestive system such as gastrectomy, gastrorrhaphy, enterectomy, etc.
5. Subjects with unusually high and/or low blood pressure, abnormal physical data and/or abnormal hematological data.
6. Subjects with severe anemia.
7. Pre- or post-menopausal women complaining of obvious physical changes.
8. Subjects who are at risk of having allergic reactions to drugs or foods especially based on onion.
9. Subjects who regularly take medicine, functional foods, and/or supplements which would affect BW and BFR.
10. Heavy smokers, alcohol addicts or subjects with disordered lifestyle.
11. 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.
12. Pregnant or lactating women or women who expect to be pregnant during this 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.
70
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, 060-8585, 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, 060-8585, 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)
2020 | Year | 06 | Month | 15 | Day |
Unpublished
Completed
2020 | Year | 05 | Month | 27 | Day |
2020 | Year | 05 | Month | 27 | Day |
2020 | Year | 08 | Month | 01 | Day |
2020 | Year | 12 | Month | 06 | Day |
2020 | Year | 06 | Month | 15 | Day |
2021 | Year | 10 | Month | 25 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046551
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