UMIN-CTR Clinical Trial

Basic information
Public title	The Ergogenic Effect of L-Citrulline. A Meta-analysis
Acronym	The Ergogenic Effect of L-Citrulline. A Meta-analysis
Scientific Title	The Ergogenic Effect of L-Citrulline. A Meta-analysis
Scientific Title:Acronym	The Ergogenic Effect of L-Citrulline. A Meta-analysis
Region	Asia(except Japan)

Condition
Condition	Healthy adults
Classification by specialty	Not applicable Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To systematically evaluate the current literature investigating the effect of CIT supplementation on exercise performance, using a meta-analytical approach
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Others
Trial characteristics_2	Others
Developmental phase	Not applicable

Assessment
Primary outcomes	Improvement in exercise performance
Key secondary outcomes

Base
Study type	Others,meta-analysis etc

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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	Not applicable
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	The studies fulfilling the following criteria were included in the analysis: 1. Study manuscript written in English; 2. Presented with data necessary to analyze the effect estimates (including baseline Vo2max mean value); 3. controlled experimental design; 4. healthy and non-clinical adult human participants (excluding elderly population); 5. Exercise in normobaric environment.
Key exclusion criteria	Exclusion criteria were as follows: 1. Study manuscript not written in English; 2. Not presented with data necessary to analyze the effect estimates; 3. Absent of controlled experimental design; 4. Clinical population; 5. Children and elderly population
Target sample size	500

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	Malaysia

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	500
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 01 Day
Date of IRB	2019 Year 05 Month 30 Day
Anticipated trial start date	2019 Year 07 Month 01 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	Electronic data-bases (Pubmed, ProQuest and SPORTDiscus) searches were conducted up to April 2019.

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=R000042108