Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000557932
Ethics application status
Approved
Date submitted
24/10/2010
Date registered
1/06/2011
Date last updated
1/06/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Exercise in combination with a diet and diet alone on agouti-related peptide and Interleukin-6 in obese and overweight sedentary female
Scientific title
The effect of Aerobic Exercise in combination with a Diet compared to a Diet alone on resting plasma concentration of agouti-related peptide and Interleukin-6 in obese and overweight sedentary female college students
Secondary ID [1] 252934 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:
Overweight 258476 0
obesity 258546 0
Condition category
Condition code
Diet and Nutrition 258641 258641 0 0
Obesity

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
In the present study, we used the weight loss program by doctor Amir and colleagues recommended 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. World journal of sport sciences, 2009, 2 (4).) Furthermore, we've used this protocol in our study (without any change in it).

Arm 1: Describe the twelve-day only Diet :
We used a weight reduction program (12 days), including researchers proposed twelve-day diet in three 4-day phases, in each phase in the first three day a decrease in nutrition occurred and in the last day a return diet to the previous phase. In the first phase, the subjects decreased 10% of their food (lunch and dinner) and then they returned to their usual eating habits (the food they received before their diet). In the second phase, first they decreased 20% in three day then they returned to 10% reduction on the fourth day. In the third phase, first they decreased 30% % in three day then they returned to 20% reduction on the fourth day. There was no limitation on drinking water and no decrease in breakfast, but the subjects avoided fat in all meals. This weight loss method was extracted from Rashid Lamir's weight loss method.

Arm 2: Describe the twelve-day Exercise + Diet:
We used a weight reduction program (Described above) along with twelve-day aerobic exercise (exercise intensity was 60 - 70 % HR max for 50 minutes) every other day. Subjects running in the outdoor environment. furthermore, they was supervised by a exercise physiologist.
Intervention code [1] 257472 0
Treatment: Other
Intervention code [2] 257522 0
Behaviour
Intervention code [3] 257523 0
Lifestyle
Comparator / control treatment
Control group was without intervention.
Control group
Active

Outcomes
Primary outcome [1] 259484 0
twelve-day diet group:
agrp in all subjects was significantly increased and IL-6 in all subjects no changed at 24 hours after the end of the weight loss program
We've collected blood samples from subjects in two stages. It had two stages for 24 hours before and 24 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] 259484 0
twelve-day diet group:
Increased appetite and no body fat loss (for all subject, the end of the weight loss program). furthermore, timepoints was assessed to 24 hours prior to commencement of diet, and at 24 hours following completion of 12 day diet
Primary outcome [2] 259485 0
twelve-day exercise along with diet group:
agrp in all subjects no significantly cheanged and IL-6 in all subjects decreased significantly at 24 hours after the end of the weight loss program
We've collected blood samples from subjects in two stages. It had two stages for 24 hours before and 24 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] 259485 0
twelve-day exercise along with diet group:
Stability in appetite and body fat loss (for all subject, the end of the weight loss program). furthermore, timepoints was assessed to 24 hours prior to commencement of diet, and at 24 hours following completion of 12 day diet
Secondary outcome [1] 268774 0
No Key secondary outcome
Timepoint [1] 268774 0
No Timepoint

Eligibility
Key inclusion criteria
All female participating were sedentary healthy adult (no disease)and they were overweight and obese.
Minimum age
18 Years
Maximum age
26 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
disease and non-adult, non- sedentaryand also they are not overwieght and obese

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation was not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
We've used the simple random sampling. Thus the people selected features were identical with those of society ( adults and overweight and obese sedentary female).Data analyzed by the one-way ANalysis Of VAriance (ANOVA) 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. (Simple randomisation by using a randomisation table created by computer software)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Safety/efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
18/04/2010
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] 257951 0
University
Name [1] 257951 0
Ferdowsi University of Mashhad
Country [1] 257951 0
Iran, Islamic Republic Of
Primary sponsor type
University
Name
Ferdowsi University of Mashhad
Address
Faculty of Physical Education and Sports Science, Ferdowsi University of Mashhad, Azadi Square, Mashhad.PostCode: 9177948974. Tel: 00985118829580 ; fax: 00985118829580.
Country
Iran, Islamic Republic Of
Secondary sponsor category [1] 266245 0
Individual
Name [1] 266245 0
Amir Rashidlamir
Address [1] 266245 0
Vice President for Research and Technology, Faculty of Physical Education and sport sciences, Ferdowsi University of Mashhad, Mashhad
Country [1] 266245 0
Iran, Islamic Republic Of

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 259937 0
the local ethic committee of Ferdowsi University of Mashhad
Ethics committee address [1] 259937 0
Ethics committee country [1] 259937 0
Iran, Islamic Republic Of
Date submitted for ethics approval [1] 259937 0
10/03/2010
Approval date [1] 259937 0
15/04/2010
Ethics approval number [1] 259937 0
3164

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

Contacts
Principal investigator
Name 31818 0
Address 31818 0
Country 31818 0
Phone 31818 0
Fax 31818 0
Email 31818 0
Contact person for public queries
Name 15065 0
Mahmoud Delphan
Address 15065 0
No355. 24 Metri ST. Khayam Sharghi blvd, Doroud, Lorestan
postcode: 6881775663
Country 15065 0
Iran, Islamic Republic Of
Phone 15065 0
00989166622007
Fax 15065 0
no fax
Email 15065 0
[email protected]
Contact person for scientific queries
Name 5993 0
Mahmoud Delphan
Address 5993 0
No355. 24 Metri ST. Khayam Sharghi blvd, Doroud, Lorestan
postcode: 6881775663
Country 5993 0
Iran, Islamic Republic Of
Phone 5993 0
00989166622007
Fax 5993 0
no fax
Email 5993 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.

Documents added automatically
No additional documents have been identified.