The effect of a period of swimming endurance training with supplementation of Ajwain on serum levels of some inflammatory factors and liver enzymes in male students
Evaluation of the simultaneous effects of endurance swimming exercises and supplementation of women on immune and hepatic inflammatory mediators
Design
60 people will be selected as a statistical sample. Subjects will be divided into four groups: Ajwain + Swimming Endurance Exercise / Ajwain / Swimming Endurance Exercise / Control. The training program will include endurance swimming and supplemental capsules for a period of 10-12 weeks. Serum concentrations of ALT, AST, CRP, and TNFα were measured in two-time stages.
Settings and conduct
We do not have blindness. According to the training program, it is probably done in the university pool. Ajwain is supplemented as a capsule according to the pilot program .
Participants/Inclusion and exclusion criteria
Inclusion criteria: No history of disease / No allergy to supplements / No high blood pressure / No heart disease
Exclusion criteria: Existence of underlying disease / being an athlete / taking any supplements
Intervention groups
Groups :
Exercise Training
Exercise and supplement of Ajwain
Supplement of Ajwain
Main outcome variables
Possible changes in serum levels of ALT and AST enzymes and inflammatory mediators CRP and TNFα
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180805040704N1
Registration date:2021-07-16, 1400/04/25
Registration timing:retrospective
Last update:2021-07-16, 1400/04/25
Update count:0
Registration date
2021-07-16, 1400/04/25
Registrant information
Name
Farah Nameni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8843 6932
Email address
dastavard96@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-06-19, 1400/03/29
Expected recruitment end date
2021-06-21, 1400/03/31
Actual recruitment start date
2021-06-19, 1400/03/29
Actual recruitment end date
2021-06-21, 1400/03/31
Trial completion date
2021-06-21, 1400/03/31
Scientific title
The effect of a period of swimming endurance training with supplementation of Ajwain on serum levels of some inflammatory factors and liver enzymes in male students
Public title
The effect of training and Ajwain on some inflammatory factors and liver enzymes
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Lack of disease history
Lack of susceptibility to supplementation
Lack of blood pressure
Lack of heart disease
Exclusion criteria:
Lack of disease
Lack of susceptibility
Age
From 18 years old to 25 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Actual sample size reached:
60
Randomization (investigator's opinion)
Randomized
Randomization description
First, all the names of all male students in the university are extracted
Then, according to the age conditions and lack of training and non-supplementation, new people are registered
After confirming the state of health and the absence of disease, their number is determined
According to the required number of considered samples (60 people) are selected by simple random method
Then, in the final stage, these 60 people will be grouped based on a simple random sampling method
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Faculty of Medical Sciences, Islamic Azad University, Varamin Pishva Branch
Street address
Tehran - Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Approval date
2019-06-16, 1398/03/26
Ethics committee reference number
IR.IAU.VARAMIN.REC.1398.007
Health conditions studied
1
Description of health condition studied
We do not have a disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Investigating the effect of exercise and Ajwain on the rate of change: CRP/ TNFa/ ALT/ AST
Timepoint
Before the research period, after the research period
Method of measurement
Special Kits
Secondary outcomes
1
Description
Possible changes in inflammatory and immune mediators in serum (TNFα, CRP, HSP70)
Timepoint
1:Before the start of the research protocol (swimming endurance training and supplementation) 2: Immediately after the end of the research protocol (swimming endurance training and supplementation)
Method of measurement
Taking blood samples in two time periods before and after the research protocol, evaluation of inflammatory and immune dependent variables using special kits and laboratory methods such as ELYZA
Intervention groups
1
Description
Exercise intervention group 1:They only do swimming endurance training
Category
N/A
2
Description
Intervention group2: Consumption of Ajwain : They only take supplements
Category
N/A
3
Description
Intervention group3 : Swimming endurance training and supplementation
Category
N/A
4
Description
Control group : It has neither exercise nor supplementation
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
IAU.VARAMIN.PISHVA
Full name of responsible person
Mohammad Aiini
Street address
Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5011
Email
info@iauvaramin.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad AIini
Street address
Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5012
Email
mohammad.aeini67@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Mohammad Aiini
Position
Wushu Coach
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5014
Email
dastavard96@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
IAU.Varamin
Full name of responsible person
Farah Nameni
Position
Assis. Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5013
Email
dastavard96@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Farah Nameni
Position
Assis. Prof.
Latest degree
Ph.D.
Other areas of specialty/work
Sport Medicine
Street address
Pishva city, Naghsh Jahan town, Islamic Azad University, Varamin branch - Pishva
City
Pishva
Province
Tehran
Postal code
33817-74895
Phone
+98 21 3672 5014
Email
dastavard96@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Not applicable
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available