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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000035049
Receipt No. 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

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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
Email 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
Email terasawa@staff.kanazawa-u.ac.jp

Sponsor
Institute Kanazawa University
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000039956

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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