UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effect of L-citrulline intake on exercise performance and fatigue in student athletes
Title of the study (Brief title)	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	Naoko Terasawa
Organization	Kanazawa University
Division name	Faculty of Human Science
Address	Kakuma, Kanazawa
TEL	076-264-5484
Email	terasawa@staff.kanazawa-u.ac.jp

Public contact
Name of contact person	Naoko Terasawa
Organization	Kanazawa University
Division name	Faculty of Human Science
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 08 Month 01 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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