UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014970 |
|---|---|
| Receipt number | R000017417 |
| Scientific Title | Double-blind, placebo-controlled study for the effects of quercetin-rich gold-onion powder on vascular endothelial function. |
| Date of disclosure of the study information | 2014/08/27 |
| Last modified on | 2014/08/27 10:32:43 |
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Basic information
Public title
Double-blind, placebo-controlled study for the effects of quercetin-rich gold-onion powder on vascular endothelial function.
Acronym
Effects of quercetin-rich onion powder on vascular endothelial function.
Scientific Title
Double-blind, placebo-controlled study for the effects of quercetin-rich gold-onion powder on vascular endothelial function.
Scientific Title:Acronym
Effects of quercetin-rich onion powder on vascular endothelial function.
Region
| Japan |
Condition
Condition
vascular endothelial dysfunction
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The main purpose is to evaluate the effectiveness of continuous ingestion (6 g/day for 4 weeks) of quercetin-rich gold species onion powder on vascular endothelial function in a double-blind, placebo-controlled study. Additionally to evaluate the benefits of onion in reducing body fat, antihypertensive effect, lowering of blood lipids, hypoglycemic effect, platelet aggregation and blood coagulation inhibition, fatigue removal, sleep quality improvement and intestinal regulation.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase III
Assessment
Primary outcomes
Fasting and post-prandial effect on FMD (flow-mediated vasodilation)
Key secondary outcomes
Body composition (weight, BMI, fat percentage, abdominal circumference, blood pressure), blood lipids (T-cho, TG, LDL-cho, HDL-cho, VLDL-cho) blood glucose (FBG, HbA1c), blood coagulation system (platelet aggregation, PT, APTT, thrombotest), high sensitivity CRP (hsCRP), VAS questionnaire (fatigue, sleep, defecation frequency etc.)
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Ingesting 6 g of quercetin-rich gold-species onion powder daily for 4 weeks.
Interventions/Control_2
Ingesting 6 g of ordinary onion powder daily for 4 weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 35 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Subjects who agree to participate in the current study with a written informed consent.
Key exclusion criteria
(1) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
(2) Subjects with unusually high and/or low blood pressure, or with abnormal hematological data, or abnormal urine test data.
(3) Subjects who are under medication or receive treatment for chronic ailments (especially cancer, cardiovascular disease, diabetes, dyslipidemia, hypertension etc.)
(4) Subjects who regularly use drugs (especially blood coagulation inhibitor, drugs to treat diabetes, drugs to treat dyslipidemia, antihypertensive drugs etc.)
(5) Subjects with a history of allergy to medicine and food, especially onions
(6) Heavy smokers and alcohol addicts, or subjects with irregular food habits.
(7) Subjects who are suffering from severe cardiac disease, liver disease, renal disease, gastrointestinal disease etc.
(8) Subjects who have undergone major surgery such as gastrectomy, gastrointestinal suture surgery, intestinal resection or any majo surgery in the digestive system.
(9) Subjects with serious anemia.
(10) Subjects who have blood coagulation disorders.
(11) Subjects who are suspected of acute infectious disease morbidity such as influenza.
(12) Subjects who donate 400ml whole blood within 12 weeks or who donate 200ml whole blood within 4 weeks or who donate plasma or platelets within 2 weeks prior to this study.
(13) Subjects who are presently participating in other clinical trials.
(14) Subjects who are not eligible due to physician's judgment.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Department of Medical Management and Informatics
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido Japan.
TEL
011-385-4411
nishihira@do-johodai.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Dir. Prof. Jun Nishihira, M.D. |
Organization
Hokkaido Information University
Division name
Health Information Science Center
Zip code
Address
59-2, Nishi Nopporo, Ebetsu, 069-8585, Hokkaido Japan.
TEL
011-385-4411
Homepage URL
http://www01.do-johodai.ac.jp/shoku/
nishihira@do-johodai.ac.jp
Sponsor or person
Institute
Hokkaido Information University
Institute
Department
Personal name
Funding Source
Organization
NOASTEC Foundation (Northern Advancement Center for Science and Technology)
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Okamoto Plant Breeding Co. Ltd.
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
北海道情報大学 保健情報センター(北海道)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 08 | Month | 27 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2012 | Year | 07 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 27 | Day |
Last modified on
| 2014 | Year | 08 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017417
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