Study of supplementation of melatonin on aerobic capacity, maximum oxygen consumption and under-maximum activity time in girls
Design
Clinical trials with control group, cross-over, randomized, 13 female physical education student
Settings and conduct
This quasi-experimental and applied research was carried out in a cross-sectional manner.The subjects visited the laboratory of Shahid Chamran physical education faculty of Ahvaz from 9 am to 12 noon.
Participants/Inclusion and exclusion criteria
Participants: Students of Ahvaz Shahid Chamran University
Entry: Non-specific disease, regular physical activity
Exit: Failure to comply with nutritional requirements
Do not use pre-test supplements
Intervention groups
in the control group, the effect of placebo on performance was investigated. In the intervention group, the effect of supplementation of melatonin on performance was investigated.
Main outcome variables
Aerobic Capacity, Time of Exhaustion during a Sub-Maximum Activity
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180325039147N1
Registration date:2018-06-25, 1397/04/04
Registration timing:retrospective
Last update:2018-06-25, 1397/04/04
Update count:0
Registration date
2018-06-25, 1397/04/04
Registrant information
Name
Fatemeh Shiravand
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 66 3322 1984
Email address
ro.ranjbar@scu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2017-11-22, 1396/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Melatonin on Aerobic Capacity and Time of Exhaustion during a Sub-Maximum Activity in Girls student in Physical Education
Public title
The Effect of Melatonin on Aerobic Capacity and Time of Exhaustion in Girls
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
regular physical activity
Lack of specific disease
Exclusion criteria:
Disrespect the nutritional requirements
Loss of supplement before the test
Age
From 20 years old to 25 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
13
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Crossover
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Shahid Chamran University of Ahvaz
Street address
golestan
City
اهواز
Province
Khouzestan
Postal code
6816853566
Approval date
2017-06-14, 1396/03/24
Ethics committee reference number
IR.BHN.REC.1396.3
Health conditions studied
1
Description of health condition studied
Time of Exhaustion,Aerobic Capacity
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
aerobic capacity
Timepoint
Measurement of aerobic capacity half an hour after taking the supplement or placebo with intervals of 5 to 7 days after intervention
Method of measurement
Measurement of Aerobic Power by Bruce Test
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: supplementation of 6 mg of melatonin (made in nature med factory of canada) with water 30 Minutes befor each test
Category
Treatment - Drugs
2
Description
Control group: 6 mg of placebo (Starch) with water 30 minutes befor each test
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Chamran University of Ahwaz
Full name of responsible person
Fatemeh Shiravand
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6816853566
Phone
+98 66 3322 1984
Email
Fatemeh71shiravand@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Dr Roohollah Ranjbar
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
۶۸۱۶۸۵۳۵۶۶
Phone
+98 66 3322 1984
Email
Fatemeh71shiravand@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Chamran University of Ahvaz
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
Shahid Chamran University Of Ahvaz
Full name of responsible person
Roohollah Ranjbar
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physical Education
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
۶۸۱۶۸۵۳۵۶۶
Phone
+98 66 3322 1984
Email
Ro.Ranjbar@Scu.Ac.Ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Fatemeh Shiravand
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Physiology
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
6816853566
Phone
+98 66 3322 1984
Email
Fatemeh71Shiravand@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shahid Chamran University of Ahvaz
Full name of responsible person
Fatemeh Shiravand
Position
Student
Latest degree
Master
Other areas of specialty/work
Physical Education
Street address
Golestan
City
Ahvaz
Province
Khouzestan
Postal code
۶۸۱۶۸۵۳۵۶۶
Phone
+98 66 3322 1984
Email
Fatemeh71shiravand@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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Only part of the information, such as information on the main outcome or the like, can be shared.
When the data will become available and for how long
Start the access period 2 months after printing results
To whom data/document is available
This data will be available to researchers working in academia and academia
Under which criteria data/document could be used
For scientific research. Rasht Students Physical Education or Nutrition
From where data/document is obtainable
shahid Chamran University odf ahvaz. Mr. Dr. Ranjbar
What processes are involved for a request to access data/document
If needed, data to complete scientific research or use it for exercise in sports