UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000035049 |
|---|---|
| Receipt number | R000039956 |
| Scientific Title | Effect of L-citrulline intake on exercise performance and fatigue in student athletes |
| Date of disclosure of the study information | 2018/11/28 |
| Last modified on | 2018/11/28 12:23:35 |
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Basic information
Public title
Effect of L-citrulline intake on exercise performance and fatigue in student athletes
Acronym
Effect of L-citrulline intake on exercise performance
Scientific Title
Effect of L-citrulline intake on exercise performance and fatigue in student athletes
Scientific Title:Acronym
Effect of L-citrulline intake on exercise performance
Region
| Japan |
Condition
Condition
Healthy
Classification by specialty
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the effect of short-term low-dose L-citrulline intake on short-time high-intensity exercise performance in student athletes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
power output by bicycle ergometer, rate of perceived exertion, and amount of nitric oxide in blood after L-citrulline intake for 7 days
Key secondary outcomes
VO2, VCO2, carbohydrate oxidation, Fat oxidation, heart rate, blood pressure, lactic acid, white blood cell count, red blood cell count, hemoglobin, hematocrit, creatine phosphokinase, serum glucose, ammonia
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Non-randomized
Randomization unit
Blinding
Double blind -all involved 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) blood sampling, heart rate and blood pressure measurement before exercise
2) short-time high-intensity exercise (Wingate test)
3) blood lactic acid and RPE measurement during exercise
4) blood sampling, heart rate and blood pressure measurement after exercise
Interventions/Control_2
1) L-citrulline or placebo intake of 3 g/day for 7 days
2) blood sampling, heart rate and blood pressure measurement before exercise
3) short-time high-intensity exercise (Wingate test)
4) blood lactic acid and RPE measurement during exercise
5) blood sampling, heart rate and blood pressure measurement after 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
| 19 | years-old | <= |
Age-upper limit
| 23 | years-old | >= |
Gender
Male
Key inclusion criteria
Japanese healthy male students at Kanazawa University who were members of the university track team and specialized mainly in middle-distance running participated
Key exclusion criteria
participants who take nutritional supplements containing L-citrulline, Arginine, ornithine, glutamine, creatine, and branched chain amino acids (BCAA) regularly, or ingest large quantities of watermelon or other types of melon for the duration of the experiment
Target sample size
9
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Naoko Terasawa |
Organization
Kanazawa University
Division name
Faculty of Human Science
Zip code
Address
Kakuma, Kanazawa
TEL
076-264-5484
terasawa@staff.kanazawa-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Naoko Terasawa |
Organization
Kanazawa University
Division name
Faculty of Human Science
Zip code
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
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
| 2018 | Year | 11 | Month | 28 | 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
| 2016 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 08 | Month | 05 | 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
| 2018 | Year | 11 | Month | 28 | Day |
Last modified on
| 2018 | Year | 11 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039956
