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 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
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
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
