UMIN-CTR Clinical Trial

Public title

Double-blind, placebo-controlled study for the effect of quercetin -rich onion (Quer-gold, Sarasara-gold) on cognitive function

Acronym

Effect of quercetin -rich onion on cognitive function

Scientific Title

Double-blind, placebo-controlled study for the effect of quercetin -rich onion (Quer-gold, Sarasara-gold) on cognitive function

Scientific Title:Acronym

Effect of quercetin -rich onion on cognitive function

Region

Japan

Condition

Improvement of cognitive function

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

YES

Narrative objectives1

The purpose is to evaluate the effect of quercetin -rich onion (Quer-gold, Sarasara-gold) on cognitive impairment by double-blind, placebo-controlled study

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Primary outcomes

Mini mental state test, Cognitive impairment rating scale

Key secondary outcomes

blood glucose, HbA1c, T-Cho, LDL-Cho, HDL-Cho, TG, oxo-LDL, estradiol, NPI-Q-J

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

YES

Dynamic allocation

NO

Institution consideration

Blocking

YES

Concealment

Central registration

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Food

Interventions/Control_1

Intake 10g of quercetin -rich onion powder (50mg quercetin) daily for 24 weeks.

Interventions/Control_2

Intake 10g of White onion powder (0mg quercetin) daily for 24 weeks.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

65

years-old

<=

Age-upper limit

85

years-old

>

Gender

Male and Female

Key inclusion criteria

(1)Subjects who show low score of Cognitive impairment rating scale
(2)Subjects who agree to participate in the current study with written informed consent.
(3) Subject with an study partner.

Key exclusion criteria

(1)Subjects who are under medication
for dementia, Alzheimer's disease,
psychiatric disorder and
cerebrovascular disease.
(2) Subjects with receiving hormone
therapy.
(3) Subjects with a history of
psychiatric disorder and
cerebrovascular disease.
(4) Subjects with serious diseases and
infections.
(5) Subjects with clinical history of
gastrointestinal surgery.
(6)Subjects with unusually high and/or low blood pressure, or with abnormal hematological data.
(7) Subjects with serious anemia.
(8)Subjects with a history of allergy to medicine and food, especially onion.
(9) Subjects routinely on supplementation which would affect cognitive function.
(10) Heavy smokers and alcohol addicts, or subjects with irregular lifestyle.
(11) Subjects who donate 400ml whole blood within 12 weeks or who donate plasma or platelets within 4 weeks prior to supplementation.
(12) Subjects who are pregnant or under lactation, or ones who would be expected to be pregnant during the study.
(13) Subjects who participate in other clinical trials within the last one month prior to the current clinical trial.
(14) Subjects who are not eligible due to physician's judgment

Target sample size

48

Name of lead principal investigator

1st name
Middle name
Last name	Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Department of Medical Management and Informatics

Zip code

Address

59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido

TEL

011-385-4411

Email

nishihira@do-johodai.ac.jp

Name of contact person

1st name
Middle name
Last name	Dir. Prof. Jun Nishihira, M.D.

Organization

Hokkaido Information University

Division name

Health Information Science Center

Zip code

Address

59-2, nishi-nopporo, ebetsu, 069-8585, Hokkaido

TEL

011-385-4430

Homepage URL

Email

nishihira@do-johodai.ac.jp

Institute

Hokkaido Information University

Institute

Department

Personal name

Organization

Ministry of Agriculture, Forestry and Fisheries

Organization

Division

Category of Funding Organization

Nationality of Funding Organization

Co-sponsor

(1)National Food Research Institute,
National Agriculture and Food Research Organization
(2)Tokushima University
(3)Gifu University
(4)National Agriculture and Food
Research Organization for Hokkaido
Region
(5)National Agriculture and Food
Research Organization for Tohoku
Region
(6)Gifu farming techniques center
(7)Kagoshima agriculture development synthesis center
(8)Okamoto Plant Breeding Co.Ltd.

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

北海道情報大学　保健センター(北海道)

Date of disclosure of the study information

2014

Year

12

Month

14

Day

URL releasing protocol

Publication of results

Unpublished

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

Recruitment status

Completed

Date of protocol fixation

2014

Year

12

Month

01

Day

Date of IRB

Anticipated trial start date

2015

Year

01

Month

20

Day

Last follow-up date

2015

Year

08

Month

08

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

12

Month

14

Day

Last modified on

2015

Year

10

Month

06

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018549