UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000017082
Receipt number R000019816
Scientific Title Effect of high quercetin diet on exercise-induced oxidatives tress and inflammation
Date of disclosure of the study information 2015/05/15
Last modified on 2015/11/09 18:06:36

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Basic information

Public title

Effect of high quercetin diet on exercise-induced oxidatives tress and inflammation

Acronym

Effect of high quercetin diet on exercise-induced oxidative stress and inflammation

Scientific Title

Effect of high quercetin diet on exercise-induced oxidatives tress and inflammation

Scientific Title:Acronym

Effect of high quercetin diet on exercise-induced oxidative stress and inflammation

Region

Japan


Condition

Condition

Healthy volunteers

Classification by specialty

Not applicable

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

The aim of this study is to investigate that the high quercetin diet can reduce the exercise-induced increase in oxidative stress and inflammation

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable


Assessment

Primary outcomes

Reactive Oxygen Metabolites (d-ROMs), Biological Anti-oxidant Potential (BAP), Interleukin-6

Key secondary outcomes

2-thiobarbituric acid reactive substances (TBARS), Ferric Reducing Ability of Plasma(FRAP), Myeloperoxidase(MPO), Interleukin-10, Differential count of leukocytes, Cortisol, Lactate


Base

Study type

Interventional


Study design

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

No treatment

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

2

Purpose of intervention

Prevention

Type of intervention

Food

Interventions/Control_1

Ten days of high quercetin diet

Interventions/Control_2

Ten days of control diet

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

18 years-old <=

Age-upper limit

30 years-old >=

Gender

Male

Key inclusion criteria

1) Healthy men assessed by perceived, clinical and biochemical parameters

Key exclusion criteria

1) patients of cardiac disease or other major chronic diseases
2) users of any medication or dietary supplements
3) smokers
4) who takes regular heavy exercise

Target sample size

20


Research contact person

Name of lead principal investigator

1st name
Middle name
Last name Yukari KAWANO

Organization

Tokyo University of Agriculture

Division name

Department of Nutritional Science

Zip code


Address

Sakuragaoka 1-1-1, Setagaya-ku, Tokyo, Japan

TEL

03-5477-2453

Email

y1kawano@nodai.ac.jp


Public contact

Name of contact person

1st name
Middle name
Last name Yukari KAWANO

Organization

Tokyo University of Agriculture

Division name

Department of Nutritional Science

Zip code


Address

Sakuragaoka 1-1-1, Setagaya-ku, Tokyo, Japan

TEL

03-5477-2453

Homepage URL


Email

y1kawano@nodai.ac.jp


Sponsor or person

Institute

Tokyo University of Agriculture

Institute

Department

Personal name



Funding Source

Organization

Tokyo University of Agriculture,
Japan Society for the Promotion of Science

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)

None


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

東京農業大学栄養科学科(東京都)
Department of Nutritional Science, Tokyo University of Agriculture


Other administrative information

Date of disclosure of the study information

2015 Year 05 Month 15 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


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

2015 Year 05 Month 28 Day

Date of IRB


Anticipated trial start date

2015 Year 05 Month 28 Day

Last follow-up date

2016 Year 03 Month 31 Day

Date of closure to data entry

2016 Year 03 Month 31 Day

Date trial data considered complete


Date analysis concluded

2016 Year 02 Month 28 Day


Other

Other related information



Management information

Registered date

2015 Year 04 Month 08 Day

Last modified on

2015 Year 11 Month 09 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019816


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name