UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038355 |
|---|---|
| Receipt number | R000043711 |
| Scientific Title | Effects of pre-exercise diet and dietary fiber on exercise performance and fatigue in male collegiate athletes |
| Date of disclosure of the study information | 2020/01/14 |
| Last modified on | 2020/04/21 10:01:03 |
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Basic information
Public title
Effects of pre-exercise diet and dietary fiber on exercise performance and fatigue in male collegiate athletes
Acronym
Effects of pre-exercise diet and dietary fiber on exercise performance and fatigue
Scientific Title
Effects of pre-exercise diet and dietary fiber on exercise performance and fatigue in male collegiate athletes
Scientific Title:Acronym
Effects of pre-exercise diet and dietary fiber on exercise performance and fatigue
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effects of pre-exercise diet and dietary fiber on exercise performance and fatigue in student athletes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
blood glucose level, power output by bicycle ergometer
Key secondary outcomes
rate of perceived exertion, VO2, VCO2, carbohydrate oxidation, fat oxidation, lactic acid
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
Individual
Blinding
Single blind -participants are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Food |
Interventions/Control_1
1) intake of dietetic food for dinner
2) pre-exercise intake of dietetic food and dietary fiber
3) pre-exercise measurement
4) exercise and during-exercise measurement
5) post-exercise measurement
Interventions/Control_2
1) intake of dietetic food for dinner
2) pre-exercise intake of dietetic food
3) pre-exercise measurement
4) exercise and during-exercise measurement
5) post-exercise measurement
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
| 21 | years-old | >= |
Gender
Male
Key inclusion criteria
Japanese healthy male students at Kanazawa University who are members of the university athletic club
Key exclusion criteria
Subjects who take medicines or supplements for treatment of blood glucose level
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | Naoko |
| Middle name | |
| Last name | Terasawa |
Organization
Kanazawa University
Division name
Faculty of Human Science
Zip code
9201167
Address
Kakuma, Kanazawa
TEL
076-264-5484
terasawa@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | Naoko |
| Middle name | |
| Last name | Terasawa |
Organization
Kanazawa University
Division name
Faculty of Human Science
Zip code
9201167
Address
Kakuma, Kanazawa
TEL
076-264-5484
Homepage URL
terasawa@staff.kanazawa-u.ac.jp
Sponsor or person
Institute
Kanazawa University
Institute
Department
Personal name
Funding Source
Organization
Kanazawa University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Kanazawa University
Address
Kakuma, Kanazawa
Tel
076-264-5484
terasawa@staff.kanazawa-u.ac.jp
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
| 2020 | Year | 01 | Month | 14 | 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
9
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
| 2019 | Year | 08 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2019 | Year | 08 | Month | 05 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 22 | Day |
Last modified on
| 2020 | Year | 04 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043711
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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