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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014315
Receipt No. R000016666
Scientific Title Molecular mechanism of quercetin to regulate amyloid-beta production in Alzheimer's disease
Date of disclosure of the study information 2014/07/18
Last modified on 2017/06/21

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Basic information
Public title Molecular mechanism of quercetin to regulate amyloid-beta production in Alzheimer's disease
Acronym Analysis of the effect of quercetin-containing onion for cognitive function and dysfunction
Scientific Title Molecular mechanism of quercetin to regulate amyloid-beta production in Alzheimer's disease
Scientific Title:Acronym Analysis of the effect of quercetin-containing onion for cognitive function and dysfunction
Region
Japan

Condition
Condition Alzheimer's disease
Classification by specialty
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Analysis of the effect of quercetin-containing onion to cognitive impairment and Alzheimer's disease
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The effect of quercetin-containing onion is analyzed by interventional trial to patient of mild cognitive impairment and Alzheimer's disease
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Cross-over
Randomization Non-randomized
Randomization unit
Blinding Single blind -participants are blinded
Control Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 Onion powder (quercetin high amount or low amount) 18g are taken every day for four weeks. Washout is for four weeks between each onion powder. The effect is analyzed by cognitive function (HDS-R, MMSE), general physical examination, neurological examination, and blood and urinary test.
Interventions/Control_2 Patients who may improve cognitive function after onion powder containing high amount of quercetin is taken for four weeks continue to eat onion powder for twelve months.
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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria mild cognitive impairment
Alzheimer's disease
Key exclusion criteria severe cognitive impairment
person cannot eat onion powder every day for four months
Target sample size 30

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Toshiyuki Nakagawa
Organization Gifu university
Division name Graduate School of Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6481
Email tnakagaw@gifu-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Toshiyuki Nakagawa
Organization Gifu university
Division name Graduate School of Medicine
Zip code
Address 1-1 Yanagido, Gifu
TEL 058-230-6481
Homepage URL
Email tnakagaw@gifu-u.ac.jp

Sponsor
Institute National Agriculture and Food Research Organization
Institute
Department

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
Address
Tel
Email

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
2014 Year 07 Month 18 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://journals.lww.com/neuroreport/pages/articleviewer.aspx?year=2016&issue=06300&article=00008&typ
Number of participants that the trial has enrolled
Results
The present study examined whether memory recall was affected by the intake of quercetin-rich onion (a new cultivar of hybrid onion Quergold) powder in early-stage AD patients. Memory recall in early-stage AD patients, determined using the Revised Hasegawa Dementia Scale, was significantly improved by the intake of quercetin-rich onion (Quergold) powder for 4 weeks compared with the intake of control onion (Mashiro white onion) powder. These results indicate that quercetin might influence memory recall.
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 04 Month 01 Day
Date of IRB
Anticipated trial start date
2011 Year 04 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 06 Month 19 Day
Last modified on
2017 Year 06 Month 21 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016666

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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