Protocol summary

Study aim
Comparison of the effects of two types of acute weight loss program (2% and 4%) on the levels of creatine kinase and cardiac troponin enzymes among wrestlers
Design
Clinical trial without control group, parallel group, randomized, cross-over design.
Settings and conduct
all subjects were weighed as fasting after three days of complete rest at the Ardabil wrestling house. Skin thickness, heart rate and blood pressure were measured and the first blood sampling was performed before the beginning of weight loss program. Then, both groups immediately lost weight by 2 and 4 percent from 9 am to 2 pm in a dry sauna at 55 °C with a frequency of 10 × 20 minutes.The second, third and fourth blood samples was taken from both groups Immediately, 6 and 24 hours later after weight loss from each subject. Finally, the samples were sent to the Ardabil Reference Laboratory for measurement. After two weeks of washout, the two groups were replaced. (The first group did 4% and the second group 2%).
Participants/Inclusion and exclusion criteria
Inclusion criteria: being healthy and having medical examinations; professional wrestling experience with competitions. Non-inclusion criteria: ergogenic supplements; infectious diseases; surgery history; Not having complete physical health
Intervention groups
Intervention group 1:Acute weight loss 2%. Intervention group 2: Acute weight loss of 4%. Subjects in each group were exposed to dry sauna for one day for up to 5 hours based on their determined weight loss (2% and 4%). These five hours consisted of at most ten 20-minute sessions to reach the desired weight. Since the study was cross-over and there was no control group, after two weeks rest, the two groups were replaced and the same procedure was performed for other group.
Main outcome variables
Cardiac troponin

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190923044853N1
Registration date: 2019-11-08, 1398/08/17
Registration timing: retrospective

Last update: 2019-11-08, 1398/08/17
Update count: 0
Registration date
2019-11-08, 1398/08/17
Registrant information
Name
reza farzizadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 45 3150 5643
Email address
reza_farzizadeh@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-07-27, 1396/05/05
Expected recruitment end date
2017-08-21, 1396/05/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the effects of two types of acute weight loss program (2% and 4%) on the levels of creatine kinase and cardiac troponin enzymes in wrestlers
Public title
The effects of rapid weight loss on the cardiac cell damage
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Health and medical examinations professional experience in wrestling with attending in competitions
Exclusion criteria:
Ergogenic Supplements Infectious diseases surgical record lack of complete physical health
Age
From 16 years old
Gender
Male
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 16
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
Ethics Committee, Research-Institute of Physical Education and Sport Sciences
Street address
No. 3, 5th alley., Mir Emad street, Motahari avenue, Tehran
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-07-01, 1398/04/10
Ethics committee reference number
IR.SSRC.REC.1398.092

Health conditions studied

1

Description of health condition studied
Acute weight loss
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Cardiac Troponin
Timepoint
At baseline (before weight loss), immediately after weight loss and 6 and 24 hours after weight loss
Method of measurement
Biochemical Auto analyzer Model BT3500 Made in Germany and Iranian Pars Azmoon Kit

Secondary outcomes

1

Description
Cardiac creatine kinase
Timepoint
At baseline (before weight loss), immediately after weight loss and 6 and 24 hours after weight loss
Method of measurement
Biochemical Auto analyzer Model BT3500 Made in Germany and Iranian Pars Azmoon Kit

Intervention groups

1

Description
"Intervention group 1:" Weight loss by 2%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 2% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group.
Category
Prevention

2

Description
"Intervention group 2:" Weight loss by 4%. After one week of weight control (pre-exercise, post-exercise and fasting), the subjects were present in the dry sauna to reduce their body weight by 4% of their initial weight. The test was conducted in a single day and up to 5 hours. These five hours consisted of at most ten 20-minute sessions until reaching the desired weight. Since the study was as cross-over, after two weeks rest, the same procedure was conducted for second group.
Category
Prevention

Recruitment centers

1

Recruitment center
Name of recruitment center
Ardabil wrestling house
Full name of responsible person
Reza Farzizadeh
Street address
Bakeri street
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3361 8030
Email
koshtiardebil@gmail.com
Web page address
http://www.koshtiardebil.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Deputy Director of Research and Technology University of Mohaghegh Ardabili
Full name of responsible person
Dr Mohammad Narimani
Street address
No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3352 0456
Email
info@uma.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy Director of Research and Technology University of Mohaghegh Ardabili
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
University of Mohaghegh Ardabili
Full name of responsible person
Reza Farzizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Department of Physical Education and Sport Sciences The sport physiology
Street address
No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil
City
Ardebil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5643
Fax
Email
reza_farzizadeh@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Reza Farzizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Department of Physical Education and Sport Sciences The sport physiology
Street address
No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5643
Fax
Email
reza_farzizadeh@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
University of Mohaghegh Ardabili
Full name of responsible person
Reza Farzizadeh
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Department of Physical Education and Sport Sciences The sport physiology
Street address
No, 179, University of Mohaghegh Ardabili, Daneshghah street, Ardabil
City
Ardabil
Province
Ardabil
Postal code
5619911367
Phone
+98 45 3150 5643
Fax
Email
reza_farzizadeh@yahoo.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
Undecided - It is not yet known if there will be a plan to make this available
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
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