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

Email

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


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

Gifu university

Address

1-1 Yanagido, Gifu

Tel

058-230-6000

Email

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name