UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000012011
Receipt number R000007971
Scientific Title Vascular endothelial function by chronic onion extract intake
Date of disclosure of the study information 2013/10/12
Last modified on 2013/10/10 11:19:32

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Basic information

Public title

Vascular endothelial function by chronic onion extract intake

Acronym

Vascular endothelial function by chronic onion extract intake

Scientific Title

Vascular endothelial function by chronic onion extract intake

Scientific Title:Acronym

Vascular endothelial function by chronic onion extract intake

Region

Japan


Condition

Condition

Postprandial endothelial dysfunction in healthy men

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To determine whether chronic onion extract intake improves postprandial endothelial dysfunction in healthy men

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Change from baseline in postprandial flow-mediated vasodilation

Key secondary outcomes



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Onion extract (51mg of quercetin) once a day for 30 days

Interventions/Control_2


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

20 years-old <=

Age-upper limit

70 years-old >

Gender

Male

Key inclusion criteria

Healthy male subjects who agree the study design and protocol

Key exclusion criteria

(1)Subjects who usually intake the foods which are added quercetin.
(2)Subjects who are implanted arteriorvenous shunts
(3)Subjects who are judged as unsuitable by questionnaires about their lifestyle
(4)Patients during any therapy
(5)Subjects who have allergies caused by test meal
(6)Subjects who have a past history of critical illness such as diabetes mellitus, hepatic disease, kidney disease or cardiac disease and so on
(7)Subjects who participated in other clinical study

Target sample size

24


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Hideki Nakayama

Organization

House Foods Corporation

Division name

SOMATECH center

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Email

hideki-nakayama@housefoods.co.jp


Public contact

Name of contact person

1st name
Middle name
Last name Hideki Nakayama

Organization

House Foods Corporation

Division name

SOMATECH center

Zip code


Address

1-4, Takanodai, Yotsukaido, Chiba, Japan

TEL

043-237-5211

Homepage URL


Email

hideki-nakayama@housefoods.co.jp


Sponsor or person

Institute

House Foods Corporation

Institute

Department

Personal name



Funding Source

Organization

House Foods Corporation

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

Department of Regeneration and Medicine
Research Center for Radiation Genome Medicine
Research Institute for Radiation Biology and Medicine
Hiroshima University

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

2013 Year 10 Month 12 Day


Related information

URL releasing protocol


Publication of results

Published


Result

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



Progress

Recruitment status

Completed

Date of protocol fixation

2011 Year 03 Month 04 Day

Date of IRB


Anticipated trial start date

2011 Year 04 Month 11 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

2013 Year 10 Month 10 Day

Last modified on

2013 Year 10 Month 10 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007971


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name