Protocol summary
-
Study aim
-
Evaluation of the effect of 12g l-citrulline supplementation before high-intensity interval exercise on the response of antioxidant markers in humans
-
Design
-
A double-blind randomized, placebo-controlled, and crossover design
-
Settings and conduct
-
After receiving participant's written and signed consent forms, their anthropometric factors such as weight, height, and body fat percentage are measured. Due to having supplementation, the researcher and participants are blinded to minimize biases. Blinding is done by the researcher assistant with coding while he knows no information about the purpose of the study and the process. Subjects consume 12g l-citrulline or placebo 1-2 hours before the start of KettleBell swing. Before exercise, first blood samples are taken from the brachial vein, after that subjects perform the protocol (16kg KettleBell swing exercise) for 12 minutes with 12 sets; then other blood samples are taken after exercise, post 10, and post 30 minutes after exercise.
-
Participants/Inclusion and exclusion criteria
-
The healthy and trained male students of the University of Guilan between 20 and 23 years old enter the study. Participants must be free of disease and injury, no history of surgery and musculoskeletal disorder during the last two years, and no history of ergogenic aids, supplements, and drug use in the last 6 months leading to the study.
-
Intervention groups
-
Intervention group: receiving l-citrulline supplementation before acute eccentric exercise ( subjects consume a solution of 12g of l-citrulline powder with water 1 to 2 hours before the start of the exercise session). Control group: receiving maltodextrin before high-intensity interval exercise ( subjects consume a solution of 12g of maltodextrin powder with water 1 to 2 hours before the start of the exercise session).
-
Main outcome variables
-
Nitric Oxide; Superoxide dismutase, Catalase, Glutathione peroxidase
General information
-
Reason for update
-
Change the title
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20210323050758N1
Registration date:
2021-04-04, 1400/01/15
Registration timing:
retrospective
Last update:
2021-04-07, 1400/01/18
Update count:
1
-
Registration date
-
2021-04-04, 1400/01/15
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2018-12-06, 1397/09/15
-
Expected recruitment end date
-
2018-12-23, 1397/10/02
-
Actual recruitment start date
-
2018-12-06, 1397/09/15
-
Actual recruitment end date
-
2018-12-23, 1397/10/02
-
Trial completion date
-
2018-12-23, 1397/10/02
-
Scientific title
-
Effects of L-citrulline supplementation on nitric oxide and antioxidant markers after high-intensity interval exercise in humans: a randomized controlled trial
-
Public title
-
Effect of L-Citrulline after high-intensity interval exercise
-
Purpose
-
Basic scienece
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
All healthy, trained male students at the University of Guilan
Exclusion criteria:
Being disease and injury free
No history of surgery and musculoskeletal disorder during the last two years
No history of ergogenic aids, supplements and drug use for in the last 6 months leading to the study
-
Age
-
From 20 years old to 23 years old
-
Gender
-
Male
-
Phase
-
N/A
-
Groups that have been masked
-
-
Sample size
-
Target sample size:
12
Actual sample size reached:
9
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
By using the lottery method, we prepare 9 sheets numbered 1to 9 that the even numbers belong to the control group and the odd numbers belong to the supplement group. Then, the lottery is done by participants. Randomization is determined by the researcher's assistant in the form of a double-blind design. Due to the crossover study, the study participants will be switched throughout to the second groups (supplement or placebo) after a washout period.
-
Blinding (investigator's opinion)
-
Double blinded
-
Blinding description
-
Both the researcher and participants did not know if participants were receiving the supplement or a placebo in the training sessions.
-
Placebo
-
Used
-
Assignment
-
Crossover
-
Other design features
-
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2019-02-04, 1397/11/15
-
Ethics committee reference number
-
IR.GUMS.REC.1397.428
Health conditions studied
1
-
Description of health condition studied
-
Evaluation of antioxidant markers
-
ICD-10 code
-
-
ICD-10 code description
-
Primary outcomes
1
-
Description
-
Nitric Oxide, Superoxide dismutase, Catalase, Glutathione peroxidase
-
Timepoint
-
Before exercise, immediately after , post 10, and post 30 after exercise
-
Method of measurement
-
Blood sampling
Intervention groups
1
-
Description
-
Intervention group: participants consume a solution of 12g of l-citrulline powder supplementation with water 1 to 2 hours before the start of the exercise. Control group: participants consume a solution of 12g of maltodextrin powder with water 1 to 2 hours before the start of the exercise.
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Rasht University of Medical Sciences
-
Proportion provided by this source
-
100
-
Public or private sector
-
Public
-
Domestic or foreign origin
-
Domestic
-
Category of foreign source of funding
-
empty
-
Country of origin
-
-
Type of organization providing the funding
-
Academic
Sharing plan
-
Deidentified Individual Participant Data Set (IPD)
-
Yes - There is a plan to make this available
-
Study Protocol
-
Yes - There is a plan to make this available
-
Statistical Analysis Plan
-
Yes - There is a plan to make this available
-
Informed Consent Form
-
Yes - There is a plan to make this available
-
Clinical Study Report
-
Yes - There is a plan to make this available
-
Analytic Code
-
No - There is not a plan to make this available
-
Data Dictionary
-
No - There is not a plan to make this available
-
Title and more details about the data/document
-
After the study, information about the main outcome will be shared.
-
When the data will become available and for how long
-
6 months after publication
-
To whom data/document is available
-
Scientific researchers
-
Under which criteria data/document could be used
-
Data and results will be available for research on L-citrulline.
-
From where data/document is obtainable
-
Javad Mehrabani
mehrabanij@guilan.ac.ir
0098 9112309074
-
What processes are involved for a request to access data/document
-
The data will be provided to the applicant within one month after review and approval.
-
Comments
-