Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12610000841077
Ethics application status
Approved
Date submitted
27/09/2010
Date registered
6/10/2010
Date last updated
21/12/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Agouti-related peptide (AgRP) in well trained wrestlers
Scientific title
Impact of two weight loss protocols on plasma levels Agouti-related peptide (agrp) in well trained wrestlers
Secondary ID [1] 252792 0
No Secondary IDs
Universal Trial Number (UTN)
U1111-1117-2345
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A total of 30 trained wrestlers were participants in a present study. All wrestlers were healthy and they had no problems and disease. 258266 0
Condition category
Condition code
Metabolic and Endocrine 258458 258458 0 0
Diabetes

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Describe the weight loss programs:
Both weight loss programs were used by the Dr. Rashidlamir and colleagues in their study in 2009. The study is published in the World Journal of Sport Sciences. In the present study, we used the weight loss program by doctor Amir and colleagues in 2009.(Amir Rashid lamir, Mahmood Goudarzi, Ali asghar ravasi: effect of gradual and acute weight loss on strength and endurance of well trained wrestlers. Word journal of sport sciences, 2009, 2 (4).)

Describe the twelve-day weight loss protocol (proposed weight loss):
Weight loss program was proposed, including three continuous stages, each stage was the fourth day:
In three days early from the first stage, We reduced the amount of 10 percent of lunch and dinner daily amount of the subjects., then on the fourth day of the first stage subjects lunch and dinner ate completely (similar to prior programs), second stage program, three days early in the second stage, We reduced the amount of 20 percent of lunch and dinner daily amount of the subjects, then on the fourth day of the second phase reduction in the amount of lunch and dinner was converted to 10 percent. In the third stage of the program, three days early in the third stage, We reduced the amount of 10 percent of lunch and dinner daily amount of the subjects, then on the fourth day of the third stage reduction in the amount of lunch and dinner was converted to 20 percent. There was no limitation on drinking water and no decrease in breakfast, but the subjects avoided fat in all meals. The program was implemented in the entire twelve days. These three steps were performed continuously in 12 days by the subjects.

Traditional weight loss protocol:

Traditional weight loss protocol was includes severe restrictions of food and sauna. Subjects performed the traditional weight loss protocols for 48 hours (severe food, and fluid limitation and sauna).Severe food restriction was two days, including a Severe food restriction in the amount of breakfast and lunch and dinner (48 hours). furthermore, They used the sauna at the end of the second day(2 haurs).
Intervention code [1] 257280 0
Other interventions
Comparator / control treatment
Control group was without intervetion.
Control group
Active

Outcomes
Primary outcome [1] 259293 0
traditional weight loss protocol group:
the main result:
agrp in all subjects was significantly increased at 12 hours after the end of the weight loss program
We've collected blood samples from subjects in two stages. It had two stages for 12 hours before and 12 hours after the execution of programs. Then blood samples by the methods for analysis and was made into a case of figures and data. Then, using the software spss (using one-way Analysis of variance) the increase was found.
Timepoint [1] 259293 0
traditional weight loss protocol group:
glycogen depletion (for all subject, the end of the weight loss program)
Previous studies have proven that one of the main reasons for increased plasma agrp by severe food restriction is glycogen depletion. According to previous studies (about agrp), we have commented (Timepoint 1).
Primary outcome [2] 259339 0
recomended weight loss protocol group:
the main result:
agrp no significant increase in all subjects at 12 hours after the end of the weight loss program
We've collected blood samples from subjects in two stages. It had two stages for 12 hours before and 12 hours after the execution of programs. Then blood samples by the methods for analysis and was made into a case of figures and data. Then, using the software spss (using one-way Analysis of variance) the increase was found.
Timepoint [2] 259339 0
recomended weight loss protocol group:
no glycogen depletion (for all subject, the end of the weight loss program)
Secondary outcome [1] 265767 0
traditional weight loss protocol:
Increased appetite (for all subject, the end of the weight loss program)
Previous studies have proven that one of the main reasons is the increasing appetite by increasing the plasma agrp. According to previous studies(about agrp), we have commented (Secondary outcome 1).
Timepoint [1] 265767 0
Traditional weight loss:
rapid increase in weight again of wrestlers (for all subject, the end of the weight loss program)
Secondary outcome [2] 265793 0
Recommended weight loss:
Stability in appetite (for all subject, the end of the weight loss program).
According to previous studies no change in plasma agrp causes the appetite does not change. According to previous studies(about agrp), we have commented (Secondary outcome ).
Timepoint [2] 265793 0
Recommended weight loss:
weight management (for all subject, the end of the weight loss program)

Eligibility
Key inclusion criteria
All wrestlers participating in adult league professional convention and they were overweight.
Minimum age
19 Years
Maximum age
29 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
Amateur wrestlers and non-adult and also they are not overwieght.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Our letter to the ethics committee as an office mail (Official) We deliver to the wrestling officials. However, this letter was not sealed. In addition, to ensure coaches and wrestlers, we have a copy of this letter and it was shown them. The reason for this was that: the subjects being studied to ensure the ethical. They understood the study methods and styles. First, letter of the University Committee for ethical approval was being studied, then this letter was given to the Board of Directors wrestling. After agreement of the Board of Directors for do procedures, we described how our study for coaches and wrestlers. The wrestlers who had qualified as volunteers participated in this study.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We used the simple random sampling. Thus, the characteristics of the participants selected were identical with their society (wrestling) (adults and overweight). Data analyzed by the One-way analysis of variance (ANOVA) for difference of between groups followed by Tukey post-hoc test was used to compare both groups with control group before and after the 12-day intervention. Data are presented as a means+/- standard deviation (DS). All calculations were made on SPSS/PC version 16.0.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other design features
There is no other design for the future.
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/03/2010
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 257759 0
University
Name [1] 257759 0
Ferdowsi University of Mashhad
Country [1] 257759 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Faculty of Physical Education and Sport Science,Ferdowsi University of Mashhad
Address
Faculty of Physical Education and Sports Science, Ferdowsi University, Azadi Square, Mashhad.PostCode: 9177948974. Tel: 00985118829580 ; fax: 00985118829580.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 256970 0
University
Name [1] 256970 0
Faculty of Physical Education and Sport Science,Ferdowsi University of Mashhad
Address [1] 256970 0
Faculty of Physical Education and Sports Science, Ferdowsi University of Mashhad, Azadi Square, Mashhad.PostCode: 9177948974. Tel: 00985118829580 ; fax: 00985118829580.
Country [1] 256970 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259802 0
The local ethic committee of Ferdowsi University of Mashhad
Ethics committee address [1] 259802 0
Ethics committee country [1] 259802 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259802 0
30/01/2010
Approval date [1] 259802 0
15/03/2010
Ethics approval number [1] 259802 0
3075

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 31701 0
Address 31701 0
Country 31701 0
Phone 31701 0
Fax 31701 0
Email 31701 0
Contact person for public queries
Name 14948 0
Mahmoud Delphan
Address 14948 0
No355. 24metri ST. Khayam Sharghi blvd, Doroud, Lorestan postcode: 6881775663
Country 14948 0
Iran, Islamic Republic Of
Phone 14948 0
0098 665 4234135
0098 916 6622007
Fax 14948 0
no fax
Email 14948 0
[email protected]
Contact person for scientific queries
Name 5876 0
Amir Rashidlamir
Address 5876 0
Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran
Country 5876 0
Iran, Islamic Republic Of
Phone 5876 0
00985118829580
Fax 5876 0
00985118829580
Email 5876 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

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