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Effects of L-citrulline supplementation on nitric oxide and antioxidant markers after high-intensity interval exercise in humans: a randomized controlled trial

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# Registration date Revision Id
2 2021-04-06, 1400/01/17 177612
1 2021-04-04, 1400/01/15 177172
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  • Protocol summary

    Evaluation of the effect of 12g l-citrulline supplementation before acute eccentric exercise on the response of antioxidant markers in humans
    Evaluation of the effect of 12g l-citrulline supplementation before high-intensity interval exercise on the response of antioxidant markers in humans
    بررسی اثر مصرف 12 گرم مکمل ال-سیترولین قبل از فعالیت شدید اکسنتریک بر پاسخ مارکرهای انتی اکسیدانی در انسان
    بررسی اثر مصرف 12 گرم مکمل ال-سیترولین قبل از فعالیت شدید تناوبی بر پاسخ مارکرهای انتی اکسیدانی در انسان
    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 eccentric exercise. 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.
    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.
    پس از دریافت فرم رضایت نامه کتبی و امضا شده شرکت کننده ، عوامل تن سنجی آنها مانند وزن ، قد و درصد چربی بدن اندازه گیری می شود. به دلیل داشتن مکمل ، محقق و شرکت کنندگان کور می شوند تا سوگیری را به حداقل برسانند. کورسازی توسط دستیار محقق با کدگذاری انجام می شود در حالی که او هیچ اطلاعی در مورد هدف مطالعه و روند کار نمی داند. افراد 1-2 ساعت قبل از شروع تمرینات اکسنتریک 12 گرم ال-سیترولین یا دارونما مصرف می کنند. قبل از ورزش ، اولین نمونه خونه از ورید بازویی گرفته می شود ، پس از آن افراد پروتکل (16 کیلوگرم تمرین چرخشی کتل بل) را به مدت 12 دقیقه در 12 مرحله انجام می دهند. سپس بعد از ورزش ، 10 و 30 دقیقه بعد از ورزش ، دیگر نمونه های خونی گرفته می شود.
    پس از دریافت فرم رضایت نامه کتبی و امضا شده شرکت کننده ، عوامل تن سنجی آنها مانند وزن ، قد و درصد چربی بدن اندازه گیری می شود. به دلیل داشتن مکمل ، محقق و شرکت کنندگان کور می شوند تا سوگیری را به حداقل برسانند. کورسازی توسط دستیار محقق با کدگذاری انجام می شود در حالی که او هیچ اطلاعی در مورد هدف مطالعه و روند کار نمی داند. افراد 1-2 ساعت قبل از شروع تمرینات کتل بل چرخشی 12 گرم ال-سیترولین یا دارونما مصرف می کنند. قبل از ورزش ، اولین نمونه خونه از ورید بازویی گرفته می شود ، پس از آن افراد پروتکل (16 کیلوگرم تمرین چرخشی کتل بل) را به مدت 12 دقیقه در 12 مرحله انجام می دهند. سپس بعد از ورزش ، 10 و 30 دقیقه بعد از ورزش ، دیگر نمونه های خونی گرفته می شود.
    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 acute eccentric exercise ( subjects consume a solution of 12g of maltodextrin powder with water 1 to 2 hours before the start of the exercise session).
    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).
    گروه مداخله: دریافت مکمل ال-سیترولین قبل از فعالیت شدید اکسنتریک. (شرکت کنندگان مقدار 12 گرم پودر مکمل ال-سیترولین بصورت محلول در اب، یک تا دو ساعت قبل از شروع فعالیت میل می کنند.) گروه کنترل: دریافت دارونما قبل از فعالیت شدید اکسنتریک. ( شرکت کنندگان مقدار 12 گرم مالتودکسترین بصورت محلول در اب، یک تا دو ساعت قبل از شروع فعالیت میل می کنند.)
    گروه مداخله: دریافت مکمل ال-سیترولین قبل از فعالیت شدید اکسنتریک. (شرکت کنندگان مقدار 12 گرم پودر مکمل ال-سیترولین بصورت محلول در اب، یک تا دو ساعت قبل از شروع فعالیت میل می کنند.) گروه کنترل: دریافت دارونما قبل از فعالیت شدید تناوبی. ( شرکت کنندگان مقدار 12 گرم مالتودکسترین بصورت محلول در اب، یک تا دو ساعت قبل از شروع فعالیت میل می کنند.)

  • General information

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    تغییر عنوان
    Effect of L-Citrulline after eccentric exercise
    Effect of L-Citrulline after high-intensity interval exercise
    اثر مصرف مکمل ال-سیترولین بعد از فعالیت اکسنتریک
    اثر مصرف مکمل ال-سیترولین بعد از فعالیت تناوبی شدید
    The effect of l-citrulline supplementation on nitric oxide and antioxidant markers after eccentric exercise in humans
    Effects of L-citrulline supplementation on nitric oxide and antioxidant markers after high-intensity interval exercise in humans: a randomized controlled trial
    اثر مصرف مکمل ال-سیترولین بر نیتریک اکساید و مارکرهای انتی اکسیدانی پس از فعالیت اکسنتریک در انسان
    اثر مصرف مکمل ال-سیترولین بر نیتریک اکساید و مارکرهای انتی اکسیدانی پس از فعالیت تناوبی شدید در انسان : ازمایش کنترل شده تصادفی

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
Name
Kosar Valaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 4428 9094
Email address
valaei_kosar@msc.guilan.ac.ir
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
  • Participant
  • Investigator
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

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Guilan University of Medical Science
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Town
City
Amol
Province
Mazandaran
Postal code
4615973557
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

Secondary outcomes

empty

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

Recruitment centers

1

Recruitment center
Name of recruitment center
Guilan University
Full name of responsible person
Kosar Valaei
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Twon
City
Amol
Province
Mazandaran
Postal code
4615973556
Phone
+98 11 4428 9094
Email
kosar.valaei94@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Mohammadreza Naghipour
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Town
City
Amol
Province
Mazandaran
Postal code
4615973556
Phone
+98 11 4428 9094
Email
kosar.valaei94@gmail.com
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

Person responsible for general inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Kosar Valaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Town
City
Amol
Province
Mazandaran
Postal code
4615973556
Phone
+98 11 4428 9094
Email
kosar.valaei94@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Kosar Valaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Town
City
Amol
Province
Mazandaran
Postal code
4615973556
Phone
+98 11 4428 9094
Email
kosar.valaei94@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Rasht University of Medical Sciences
Full name of responsible person
Kosar Valaei
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
No. 14, Farhang Ave., Talebamoli Blvd., Amol Town
City
Amol
Province
Mazandaran
Postal code
4615973556
Phone
+98 11 4428 9094
Email
kosar.valaei94@gmail.com

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.
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