UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015543 |
|---|---|
| Receipt number | R000018057 |
| Scientific Title | Influence the intake of supplements give to exercise performance and oxidative stress. |
| Date of disclosure of the study information | 2014/10/27 |
| Last modified on | 2015/04/27 12:58:16 |
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Basic information
Public title
Influence the intake of supplements give to exercise performance and oxidative stress.
Acronym
Influence the intake of supplements give to exercise performance and oxidative stress.
Scientific Title
Influence the intake of supplements give to exercise performance and oxidative stress.
Scientific Title:Acronym
Influence the intake of supplements give to exercise performance and oxidative stress.
Region
| Japan |
Condition
Condition
Healthy individual.
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Changes in exercise performance and oxidative stress when the supplement was ingested 2 weeks.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The average power by the exercise bike.
Key secondary outcomes
Oxidant stress
Blood lactic acid
Oxygen uptake
Maximum oxygen uptake
Amount of fat burned
Carbohydrate combustion amount
Heart rate
etc.
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
Test substance group
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
Who belong to the movement part
Key exclusion criteria
1)Heavy sequela or severe disease.
2)High blood pressure or diabetes.
3)The person who is unsuitable for the entry judged by a officer.
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaaki SUGITA, Ph.D. |
Organization
Mie University
Division name
Faculty of Education, Health and Physical Education Department.
Zip code
Address
1577 Kurima MAchiyamachi, Tsu, Mie 514-8507, Japan
TEL
059-232-1211
sugita@edu.mie-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Koji Umeda,Ph.D. |
Organization
KSK Laboratories,Inc.
Division name
representative
Zip code
Address
t.c.p 4F,7-15 Daimon, Tsu, Mie 514-0027, Japan
TEL
059-253-8091
Homepage URL
http://www.ksk-lab.co.jp
info@ksk-lab.co.jp
Sponsor or person
Institute
Mie University, Graduate School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Mie University Faculty of Education, Health and Physical Education Department
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
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
三重大学 教育学部棟
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | Month | 27 | 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
| 2014 | Year | 09 | Month | 02 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 28 | 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
| 2014 | Year | 10 | Month | 27 | Day |
Last modified on
| 2015 | Year | 04 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018057
