To find out whether orange peel extract has an effect on the performance and improvement of swimmers' records
Design
Three groups are used, a placebo group, a single-dose group, and a two-dose group are used in parallel.
Settings and conduct
The pre-test and post-test are held in an indoor pool with a temperature of 25 degrees Celsius, 50 meters long and 18 meters wide, and the pooling is done in such a way that one person, who is neither a researcher nor a supervisor or analyst, divides the participants into three groups and the drugs or a placebo is given.
Participants/Inclusion and exclusion criteria
Must be Tehrani expert male swimmers between 11 and 18 years old
Intervention groups
The intervention is in the form of capsules, which includes a placebo, one dose and two doses, in the placebo, flour is used, and the capsules contain 80% orange peel extract and 20% food additives are allowed.
Main outcome variables
Does the extract of orange peel delay the performance and improvement of the record and the time to reach fatigue of Tehrani male swimmers, and the aerobic and anaerobic capacity of the swimmers is evaluated.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221226056935N1
Registration date:2023-06-26, 1402/04/05
Registration timing:prospective
Last update:2023-06-26, 1402/04/05
Update count:0
Registration date
2023-06-26, 1402/04/05
Registrant information
Name
Seyyed ali Zahedi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7750 1864
Email address
s.alizahedi@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-28, 1402/04/07
Expected recruitment end date
2023-07-19, 1402/04/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of orange peel extract on the performance and improving the record of Tehrani male swimmers and the time to reach fatigue
Public title
The effect of orange peel extract on the performance and record improvement of Tehrani male swimmers and the time to reach fatigue
Purpose
Basic scienece
Inclusion/Exclusion criteria
Inclusion criteria:
Only expert swimmers, Tehrani boys, 11 to 18 years old, Nofalah pool
Exclusion criteria:
Age
From 11 years old to 18 years old
Gender
Male
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
24 expert male swimmers from Tehran will be randomized into three groups of 8 people and will be used in the form of code in the rest of the research (group one placebo, group two one dose of drug and group three two rounds of drug) and because of this randomization, each person There is an equal chance to be placed in each of the groups that the researchers and participants in the study are not able to predict the type of intervention received, and the first step is to create a random sequence and the second step is to hide the sequence, which increases the reliability of the research. will be.
Blinding (investigator's opinion)
Double blinded
Blinding description
It is the case that a third person other than the researcher and the supervisor and the participants in the research is present to eliminate the psychological effect of the drug or orange peel extract supplement so that the results of the work show the real effect of the drug to the researcher.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Assistant Azad University of Tehran, Sohank Center
Street address
Province complex Islamic Azad University, Central Tehran branch The big end of the army road, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1955847881
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.IAU.CTB.REC.1402.010
Health conditions studied
1
Description of health condition studied
Effect of orange peel extract on aerobic and anaerobic performance
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Orange peel extract and sympathetic imitation
Timepoint
21. After eating the test capsule, the post-test will be taken
Method of measurement
Chronometer and recording
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:A medicinal dose (one capsule) is given.
Category
Diagnosis
2
Description
Intervention group: Two doses of medicine (two capsules) are given.
Category
Diagnosis
3
Description
Control group: It is given from empty capsules containing flour.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Nofalah pool in Tehran
Full name of responsible person
Seyyed Ali Zahedi
Street address
Shahid Nofalah pool, Next to the wrestling hall Workash St Muftah St., Tehran, Iran
City
tehran
Province
Tehran
Postal code
1573613131
Phone
+98 21 8883 5350
Email
s.alizahedi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Ali Azarbaijani
Street address
Province complex Azad University of Tehran, Sohank Center Shahid Sohani St., The big end of the army road, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1955847881
Phone
+98 21 7368 1103
Email
ali.azarbayjani@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Clothing retail
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Other
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
seyyed ali zahedi
Position
A student studying
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Unit 4, No. 1, Blossom dead end Shahid Homayun Natghi St., Shemiran Gate, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1151913975
Phone
+98 21 7750 1864
Email
s.alizahedi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
seyyed ali zahedi
Position
A student studying
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Unit 4, No. 1, Blossom dead end Shahid Homayun Natghi St., Shemiran Gate, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1151913975
Phone
+98 21 7750 1864
Email
s.alizahedi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
seyyed ali zahedi
Position
A student studying
Latest degree
Bachelor
Other areas of specialty/work
Physiology
Street address
Unit 4, No. 1, Blossom dead end Shahid Homayun Natghi St., Shemiran Gate, Tehran, Iran
City
tehran
Province
Tehran
Postal code
1151913975
Phone
+98 21 7750 1864
Email
s.alizahedi@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
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
According to the supervisor's decision
When the data will become available and for how long
According to the supervisor's decision
To whom data/document is available
According to the supervisor's decision
Under which criteria data/document could be used
According to the supervisor's decision
From where data/document is obtainable
According to the supervisor's decision
What processes are involved for a request to access data/document