Effects of a L-citrulline supplementation on nitric oxide and blood lactate in young women after a maximum exercise session
Design
A randomised, placebo-controlled and double-blind design
Settings and conduct
The present study performed in vitro, in the laboratory of Exercise Physiology, the faculty of physical activity and sport sciences, Alzahra university. Subjects and researcher were blinded to the consumption of L-citrulline and placebo.
Participants/Inclusion and exclusion criteria
Inclusion criteria: subjects were physically healthy (no history of any cardiovascular disease, no history of specific or neuropsychiatric disease), no allergy to substances and drugs, no use of any dietary supplement, medication or nutritional regimen in the last 3 months, lack of regular exercises in the last 6 months.
Intervention groups
Intervention group: group of supplement consumed daily 6 grams capsules of powdered L-citrulline (NOW, USA) for one week.
Control group: group of placebo consumed daily 6 grams capsules of powdered starch (Seiti, Iran) for one week.
Main outcome variables
Time to exhaustion, nitric oxide and blood lactate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181125041749N1
Registration date:2019-08-25, 1398/06/03
Registration timing:retrospective
Last update:2019-08-25, 1398/06/03
Update count:0
Registration date
2019-08-25, 1398/06/03
Registrant information
Name
Fahimeh Kazemi
Name of organization / entity
Alzahra University
Country
Iran (Islamic Republic of)
Phone
+98 21 8569 2689
Email address
kazemi.fahimeh@yahoo.de
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-01-21, 1397/11/01
Actual recruitment start date
2018-11-29, 1397/09/08
Actual recruitment end date
2019-02-01, 1397/11/12
Trial completion date
2019-02-01, 1397/11/12
Scientific title
Effects of a L-citrulline supplementation on nitric oxide and blood lactate in young women after a maximum exercise session
Public title
Effects of a L-citrulline supplementation on nitric oxide and lactate after exercise
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Subjects were physically healthy (no history of any cardiovascular disease, no history of specific or neuropsychiatric disease),
no allergy to substances and drugs,
no use of any dietary supplement, medication or nutritional regimen in the last 3 months,
lack of regular exercises in the last 6 months.
Exclusion criteria:
Age
From 24 years old to 29 years old
Gender
Female
Phase
3
Groups that have been masked
Participant
Investigator
Sample size
Target sample size:
24
Actual sample size reached:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Using the draw method, subjects' names were written on separate papers and placed in a container. Then the names of the subjects were randomly selected and placed in the intervention or placebo groups. The first 12 names were placed in the intervention group and the rest in the placebo group.
Blinding (investigator's opinion)
Double blinded
Blinding description
Researcher and subjects were not aware of the allocation of groups, and the supplement and placebo appearance was similar in both groups. An unrelated person to the study encoded the supplement and placebo.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Sports Sciences Research Institute
Street address
No. 3, 5th Alley, Miremad St., Motahhari St
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.SSRC.REC.1398.050
Health conditions studied
1
Description of health condition studied
Sports supplements
ICD-10 code
Y93.A
ICD-10 code description
Activities involving other cardiorespiratory exercise
Primary outcomes
1
Description
Time to exhaustion
Timepoint
Before the intervention and one week after the intervention
Method of measurement
With signs and symptoms of exhaustion
Secondary outcomes
1
Description
Nitric oxide
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Elisa kit
2
Description
Blood lactate
Timepoint
Before the intervention and one week after the intervention
Method of measurement
Elisa kit
Intervention groups
1
Description
Intervention group: group of supplement consumed daily 6 grams capsules of powdered L-citrulline (NOW, USA) for one week.
Category
Treatment - Other
2
Description
Control group: group of placebo consumed daily 6 grams capsules of powdered starch (Seiti, Iran) for one week.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Noor Pathobiology Laboratory
Full name of responsible person
Keyvan Majidi
Street address
No. 93, Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
۱۴۱۸۷۵۵۱۶۱
Phone
+98 21 6642 9871
Email
keyvan_majidi@noorlab.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Alzahra University
Full name of responsible person
Yadollah Ordokhani
Street address
Alzahra University, Deh-e Vanak St
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2202
Email
ordokhani@alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Alzahra University
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
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Fahimeh Kazemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Exercise Physiology
Street address
Faculty of Physical Education and Sport Sciences, Alzahra University, Deh-e Vanak St
City
Tehran
Province
Tehran
Postal code
۱۹۹۳۸۹۳۹۷۳
Phone
+98 21 8569 2689
Email
f.kazemi@alzahra.ac.ir
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
Not applicable
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Data relating to subjects will be shared as unidentified.
When the data will become available and for how long
Six months after the publication of the article.
To whom data/document is available
All researchers
Under which criteria data/document could be used
Data is allowed to use in case of citing the reference.
From where data/document is obtainable
Atefeh Freidooni
What processes are involved for a request to access data/document