UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000012011 |
|---|---|
| Receipt number | R000007971 |
| Scientific Title | Vascular endothelial function by chronic onion extract intake |
| Date of disclosure of the study information | 2013/10/12 |
| Last modified on | 2013/10/10 11:19:32 |
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Basic information
Public title
Vascular endothelial function by chronic onion extract intake
Acronym
Vascular endothelial function by chronic onion extract intake
Scientific Title
Vascular endothelial function by chronic onion extract intake
Scientific Title:Acronym
Vascular endothelial function by chronic onion extract intake
Region
| Japan |
Condition
Condition
Postprandial endothelial dysfunction in healthy men
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine whether chronic onion extract intake improves postprandial endothelial dysfunction in healthy men
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change from baseline in postprandial flow-mediated vasodilation
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Onion extract (51mg of quercetin) once a day for 30 days
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy male subjects who agree the study design and protocol
Key exclusion criteria
(1)Subjects who usually intake the foods which are added quercetin.
(2)Subjects who are implanted arteriorvenous shunts
(3)Subjects who are judged as unsuitable by questionnaires about their lifestyle
(4)Patients during any therapy
(5)Subjects who have allergies caused by test meal
(6)Subjects who have a past history of critical illness such as diabetes mellitus, hepatic disease, kidney disease or cardiac disease and so on
(7)Subjects who participated in other clinical study
Target sample size
24
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hideki Nakayama |
Organization
House Foods Corporation
Division name
SOMATECH center
Zip code
Address
1-4, Takanodai, Yotsukaido, Chiba, Japan
TEL
043-237-5211
hideki-nakayama@housefoods.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hideki Nakayama |
Organization
House Foods Corporation
Division name
SOMATECH center
Zip code
Address
1-4, Takanodai, Yotsukaido, Chiba, Japan
TEL
043-237-5211
Homepage URL
hideki-nakayama@housefoods.co.jp
Sponsor or person
Institute
House Foods Corporation
Institute
Department
Personal name
Funding Source
Organization
House Foods Corporation
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of Regeneration and Medicine
Research Center for Radiation Genome Medicine
Research Institute for Radiation Biology and Medicine
Hiroshima University
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 10 | Month | 12 | Day |
Related information
URL releasing protocol
Publication of results
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
| 2011 | Year | 03 | Month | 04 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 04 | Month | 11 | 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
| 2013 | Year | 10 | Month | 10 | Day |
Last modified on
| 2013 | Year | 10 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007971
