UMIN-CTR Clinical Trial

Basic information
Public title	The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Acronym	The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title	The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Scientific Title:Acronym	The Effect of Acute and Chronic L-Citrulline Extract Supplementation on Vasodilatory, Nitric Oxide Bioavailability and Exercise Performance in Human Adults
Region	Asia(except Japan)

Condition
Condition	Healthy adults
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	to assess the effects of a single and repeated doses of L-Citrulline extract over 16 days, on resting blood pressure, nitric oxide level and exercise performance in human adults
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	1. Resting blood pressure (systolic blood pressure, diastolic blood pressure and mean arterial pressure) 2. Continuous and intermittent endurance exercise performance
Key secondary outcomes	1. Nitric oxide level 2. Renal function (Urea nitrogen, Creatine) 3. Blood glucose and blood lactate 4. Plasma sodium and potassium 5. Oxygen cost of exercise 6. Oxidant and antioxidant markers 7. Cognitive function

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
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	Medicine Other
Interventions/Control_1	6 grams per day of L-citrulline
Interventions/Control_2	Placebo capsule not containing L-citrulline
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	45 years-old >
Gender	Male
Key inclusion criteria	1. Healthy recreationally active males 2. Free from injury. 3. Do not have any current or history of cardiovascular, metabolic, or pulmonary disease 4. No contraindication for blood sampling procedure. 5. Pass The Physical Activity Readiness Questionnaire (PAR-Q)
Key exclusion criteria	1. Smoker 2. Individual who consume any dietary supplements, quasi drugs or medicines within past 4 weeks. 3. On medication 4. Receiver of blood transfusion within 1 month prior to screening 5. Receiver of any investigational research agent prior to 30 days of experimental trial and individual who have a history of or current clinically significant disease. 6. Clinical population or an individual with heart/vascular related problem 7. Individual with the medical histories of alcoholism or drug dependence 8. Individual who have contraindication with high intensity exercise
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Adam Middle name Last name Linoby
Organization	Universiti Teknologi MARA
Division name	Faculty of Sports Science and Recreation
Zip code	70300
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri Sembilan, Malaysia
TEL	+60133632005
Email	linoby@uitm.edu.my

Public contact
Name of contact person	1st name Adam Middle name Last name Linoby
Organization	Universiti Teknologi MARA
Division name	Faculty of Sports Science and Recreation
Zip code	70300
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3, Seremban, Negeri
TEL	+60133632005
Homepage URL	https://seremban.uitm.edu.my/
Email	linoby@uitm.edu.my

Sponsor
Institute	Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Institute
Department

Funding Source
Organization	Fundamental Research Grant Scheme, Ministry of Higher Education (Malaysia)
Organization
Division
Category of Funding Organization	Outside Japan
Nationality of Funding Organization	Universiti Teknologi MARA (UiTM) Cawangan Negeri Sembilan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	Faculty of Sports Science and Recreation, Universiti Teknologi MARA
Address	UiTM Cawangan Negeri Sembilan, Kampus Seremban, Jalan Seremban Tiga/1, Seremban 3
Tel	+606-6342409
Email	shari0971@uitm.edu.my

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	2019 Year 06 Month 04 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	18
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	2018 Year 12 Month 05 Day
Date of IRB	2018 Year 04 Month 10 Day
Anticipated trial start date	2019 Year 06 Month 04 Day
Last follow-up date	2020 Year 12 Month 01 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 06 Month 04 Day
Last modified on	2019 Year 06 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042109