UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014267 |
|---|---|
| Receipt number | R000016614 |
| Scientific Title | Effect of skipping breakfast on post-exercised muscle damages and immunological responses |
| Date of disclosure of the study information | 2014/06/20 |
| Last modified on | 2014/12/15 16:16:54 |
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Basic information
Public title
Effect of skipping breakfast on post-exercised muscle damages and immunological responses
Acronym
Effect of skipping breakfast on post-exercised muscle damages and immunological responses
Scientific Title
Effect of skipping breakfast on post-exercised muscle damages and immunological responses
Scientific Title:Acronym
Effect of skipping breakfast on post-exercised muscle damages and immunological responses
Region
| Japan |
Condition
Condition
Adult
Classification by specialty
| Not applicable | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The breakfast intakes might contribute to preventing exercise-induced changes in muscle protein damages, immunological responses, or exercise performances
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Perceived muscle soreness, Muscle protein degradation, Exercise performance
Key secondary outcomes
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
Educational,Counseling,Training
Type of intervention
| Behavior,custom |
Interventions/Control_1
Breakfast taking with resistance exercise
Interventions/Control_2
Skipping breakfast with resistance exercise
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
| 25 | years-old | > |
Gender
Male
Key inclusion criteria
Healthy men assessed by perceived, clinical and biochemical parameters.
Key exclusion criteria
1. The person under medication and medical treatment
2. The person who are performing intensive physical activities
3. The person with an infection in the mouth or gingivitis
4. The person who cannot continue the research for one month
Target sample size
10
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 Sciences
Zip code
Address
Sakuraoka1-1-1, Setagaya, Tokyo
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 Sciences
Zip code
Address
Sakuraoka1-1-1, Setagaya, Tokyo
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
None
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 06 | Month | 20 | 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 | 06 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 06 | Month | 20 | Day |
Last follow-up date
| 2014 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2015 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2015 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2015 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2014 | Year | 06 | Month | 15 | Day |
Last modified on
| 2014 | Year | 12 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016614
