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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]

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.

Condition category

Condition code

Metabolic and Endocrine

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]

Other interventions

Comparator / control treatment

Control group was without intervetion.

Control group

Active

Outcomes

Primary outcome [1]

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]

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]

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]

recomended weight loss protocol group:
no glycogen depletion (for all subject, the end of the weight loss program)

Secondary outcome [1]

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]

Traditional weight loss:
rapid increase in weight again of wrestlers (for all subject, the end of the weight loss program)

Secondary outcome [2]

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]

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

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

Funding & Sponsors

Funding source category [1]

University

Name [1]

Ferdowsi University of Mashhad

Address [1]

Faculty of Physical Education and Sports Science, Ferdowsi University, Azadi Square, Mashhad.PostCode: 9177948974. Tel: 00985118829580 ; fax: 00985118829580.

Country [1]

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]

University

Name [1]

Faculty of Physical Education and Sport Science,Ferdowsi University of Mashhad

Address [1]

Faculty of Physical Education and Sports Science, Ferdowsi University of Mashhad, Azadi Square, Mashhad.PostCode: 9177948974. Tel: 00985118829580 ; fax: 00985118829580.

Country [1]

Iran, Islamic Republic Of

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

The local ethic committee of Ferdowsi University of Mashhad

Ethics committee address [1]

Department of physical education and sport sciences, Ferdowsi University, Azadi Square, Mashhad, iran, PostCode: 9177948974, Tel: 00985118829580 ; fax: 00985118829580.

Ethics committee country [1]

Iran, Islamic Republic Of

Date submitted for ethics approval [1]

30/01/2010

Approval date [1]

15/03/2010

Ethics approval number [1]

3075

Summary

Brief summary

Background: AGRP  is secreted from central part of the arcuate nucleus in the hypothalamus and candidate gene for human fatness, an appetite stimulator peptide and an acute motivator for appetite. It has an effective role on reception and selecting food, weight control and energy homeostasis. The aim of the present study was to investigate the impact of two weight loss protocol on the plasma AGRP in well trained wrestlers.
Methods: Thirty trained wrestlers (The mean age of subjects: 24.33+/- 3.33, The mean Body mass index of subjects: 24.90+/-2.38, The mean body fat percentage of subjects:12.92+/-3.01) divided into the two experimental groups and one control group. Experimental group I: Used a 12-day weight loss program with three sessions per week practicing wrestling. Experimental groupII: Used the traditional two-day weight loss program and Sauna (DS) and Control group was without diet. Blood samples (10 cc from-brachial vein) were collected before and twelve hours after doing protocol. Furthermore, subject’s percent of body fat was measured with three point method. The levels of plasma AGRP was measured with special kit using Enzyme-Linked Immunosorbent Assay (ELISA) method. One way analysis of variance (ANOVA) was used for data processing and analysis by spss-16.
Results: Both experimental groups have a significant reduction on body weight (p<0.001). D group has a significant reduction on percent of body fat (p<0.05). the  plasma levels AGRP in the DS group has significantly increased (p<0.001).
Conclusions: However, in aspect of descriptive consequence that traditional method (sauna, restriction food) couldn’t be a suitable method for weight loss. Furthermore, it may have harmful effects on wrestler’s performance, and also increasing of AGRP can be a sign of reduction of muscle glycogen stores. As well, the DS Group of wrestlers was a loss their weight in Non-academic method. This method has a negative effect on their performance. D Group showed a significant decrease in weight but there wasn’t significant increase in plasma AGRP levels. Furthermore, because of no significant change in percent of body fat, the weight loss in traditional method may be due to body dehydration and restriction food intake.

Trial website

no website

Trial related presentations / publications

Our present study was evaluated by reviewers of the Journal of Strength and Conditioning Research (JSCR), which is currently under revise by researchers.

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Mahmoud Delphan

Address

No355. 24metri ST. Khayam Sharghi blvd, Doroud, Lorestan postcode: 6881775663

Country

Iran, Islamic Republic Of

Phone

0098 665 4234135
0098 916 6622007

Fax

no fax

[email protected]

Contact person for scientific queries

Name

Amir Rashidlamir

Address

Faculty of Physical Education and Sport Sciences, Ferdowsi University of Mashhad, Mashhad, Iran

Country

Iran, Islamic Republic Of

Phone

00985118829580

Fax

00985118829580

[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.

Documents added automatically

No additional documents have been identified.

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