UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000014315
Receipt number 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 13:22:29

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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

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

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 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


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

Value
https://center6.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