UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033258 |
|---|---|
| Receipt number | R000037914 |
| Scientific Title | Development of quercetin-containing onion for cognitive function and dysfunction |
| Date of disclosure of the study information | 2018/08/01 |
| Last modified on | 2022/07/06 09:27:11 |
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Basic information
Public title
Development of quercetin-containing onion for cognitive function and dysfunction
Acronym
Analysis of quercetin for cognitive function and dysfunction
Scientific Title
Development of quercetin-containing onion for cognitive function and dysfunction
Scientific Title:Acronym
Analysis of quercetin for cognitive function and dysfunction
Region
| Japan |
Condition
Condition
mild cognitive impairment (MCI)
Alzheimer's disease
Classification by specialty
| Neurology | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Analysis of the effect of quercetin containing onion to mild cognitive impairment, MCI, and Alzheimer disease patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The effect of quercetin-containing onion intake for 12 weeks is analyzed by interventional trial to patient of mild cognitive impairment and Alzheimer disease.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Onion powder (quercetin high amount) 9g are taken every day for twelve weeks. The effect is analyzed by cognitive function (HDS-R, MMSE) and BPSD assessment (Neuropsychiatric Inventory: NPI), general physical examination, neurological examination, and blood and urinary test.
Interventions/Control_2
Onion powder (quercetin low amount) 9g are taken every day for twelve weeks. The effect is analyzed by cognitive function (HDS-R, MMSE) and BPSD assessment (Neuropsychiatric Inventory: NPI), general physical examination, neurological examination, and blood and urinary test.
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
| 65 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
mild cognitive impairment
Alzheimer disease
Key exclusion criteria
severe cognitive impairment
person cannot eat onion powder every day for three months
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Gifu university
Division name
Graduate School of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6481
tnakagaw@gifu-u.ac.jp
Public contact
Name of contact person
| 1st name | Toshiyuki |
| Middle name | |
| Last name | Nakagawa |
Organization
Gifu university
Division name
Graduate School of Medicine
Zip code
501-1194
Address
1-1 Yanagido, Gifu
TEL
058-230-6481
Homepage URL
tnakagaw@gifu-u.ac.jp
Sponsor or person
Institute
National Agriculture and Food Research Organization
Institute
Department
Personal name
Funding Source
Organization
National Agriculture and Food Research Organization
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Gifu university
Address
1-1 Yanagido, Gifu
Tel
058-230-6000
rinri@gifu-u.ac.jp
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
| 2018 | Year | 08 | Month | 01 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
19
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
Results are delayed because manuscript is preparing.
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
| 2018 | Year | 06 | Month | 06 | Day |
Date of IRB
| 2018 | Year | 06 | Month | 06 | Day |
Anticipated trial start date
| 2018 | Year | 06 | Month | 06 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2021 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2021 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2021 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 03 | Day |
Last modified on
| 2022 | Year | 07 | Month | 06 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037914
