Protocol summary

Study aim
The Survey of the effect of eight weeks of compound training(resistance training and HIIT) with several types of weight loss diet plans for some of the blood and anthropometric variables in overweight women
Design
Through interviewing, at first, introducing the purpose, the patients' consent will first be taken by oral and written statement, and then the participants will be randomly divided and after the measurement and blood sampling by holding a nutrition and training workshop as well as presenting a nutrition and a workout program (if necessary) specific to each individual, the work will begin and after eight weeks the blood samples will be taken again.
Settings and conduct
All stages (questionnaire, anthropometric measurements, training and design of exercise and nutrition program) are taking place at the nutrition clinic, blood sampling in the laboratory of Labfi Nejad Hospital and performing the exercise protocol in the gym.
Participants/Inclusion and exclusion criteria
Participants will be overweight women in Tehran from 30 to 40 years old(bmi=25-30), who will be selected from the volunteers participating in the study by random sampling method.
Intervention groups
50 healthy women between 30 and 40 years of age were randomly divided into two groups of 25 individuals with high protein diet group and 25 individuals with standard diet group with exercise training for both groups, and comparing the changes in fat percentage, skeletal muscle mass, bmi and renal variables By exercising with diet (high protein and standard) in overweight women at the time of weight loss
Main outcome variables
Finding the right diet at a time of weight loss with exercise so that the person experiences a healthy weight loss and maintain muscle mass and only reduce the percentage of fat and size. Variables: weight, bmi, smm, pbf, whr, bun, creatinine, uric acid

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20190625044010N1
Registration date: 2019-07-07, 1398/04/16
Registration timing: registered_while_recruiting

Last update: 2019-07-07, 1398/04/16
Update count: 0
Registration date
2019-07-07, 1398/04/16
Registrant information
Name
sussan ramsari
Name of organization / entity
Alzahra University
Country
Iran (Islamic Republic of)
Phone
+98 21 2294 4094
Email address
sussanramsari@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-07-06, 1398/04/15
Expected recruitment end date
2019-08-31, 1398/06/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of compound training(resistance training and HIIT) with several types of weight loss diet plans for some of the blood and anthropometric variables in overweighted women
Public title
The effect of exercise and several types of weight loss diet plans in overweight women
Purpose
Other
Inclusion/Exclusion criteria
Inclusion criteria:
Women Healthy 30-40 years old Overweight(bmi=25-30)
Exclusion criteria:
Age
From 30 years old to 40 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 50
More than 1 sample in each individual
Number of samples in each individual: 2
the Survey of some of the blood and anthropometry variables
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Factorial
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Reasearch Ethics committee of Sport Sciences Research Institute of Iran
Street address
No. 3, 5th Alley, Miremad Street, Motahhari Street.
City
Tehran
Province
Tehran
Postal code
1587958711
Approval date
2019-06-25, 1398/04/04
Ethics committee reference number
http://ethics.research.ac.ir/IR.SSRC.REC.1398.038

Health conditions studied

1

Description of health condition studied
The effect of eight weeks of compound training(resistance training and HIIT) with several types of weight loss diet plans for some of the blood and anthropometric variables in overweighted women
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
Weight, skeletal muscle mass(SMM), percent body fat(PBF), body mass index(BMI),waist-hip ratio(WHR)
Timepoint
Anthropometry using body composition(Inbody270)once before the research and once 48 hours after the last session of exercise.
Method of measurement
Anthropometry using body composition(Inbody270), general questionnaire containing age, medical history, athletic, therapeutic and pharmaceutical consumption history

2

Description
BUN, Creatinin ,Uric Acid
Timepoint
The blood sampling once before the research and once 48 hours after the last session of exercise.
Method of measurement
The blood test information(blood sampling in laboratory occurs one day before starting the training and 48 hours after the last session of the training by taking 5 ml from the area of the elbow while the subject has fasted for 8 hours )

Secondary outcomes

1

Description
Weight, skeletal muscle mass(SMM), percent body fat(PBF), body mass index(BMI),waist-hip ratio(WHR)
Timepoint
Anthropometry using body composition(Inbody270)once before the research and once 48 hours after the last session of exercise.
Method of measurement
Anthropometry using body composition(Inbody270), general questionnaire containing age, medical history, athletic, therapeutic and pharmaceutical consumption history

Intervention groups

1

Description
Intervention group: compound training with high protein diet group
Category
Other

2

Description
Control group: compound training with standard diet group
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Sussan Ramsari Nutrition Clinic
Full name of responsible person
Sussan Ramsari
Street address
No. 9, P 10, Ahmadi Ave., Nirooye Daryayi St., Resalat Sq.
City
Tehran
Province
Tehran
Postal code
1676715433
Phone
+98 21 7724 2677
Email
sussanramsari@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Alzahra University
Full name of responsible person
Afsaneh shemshaki
Street address
Alzahra University, Dehe vanak
City
Tehran
Province
Tehran
Postal code
1993891176
Phone
+98 21 8804 4040
Fax
+98 21 8803 5187
Email
pr@alzahra.ac.ir
Web page address
http://www.alzahra.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Alzahra University
Proportion provided by this source
100
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
Alzahra University
Full name of responsible person
Sussan Ramsar
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 5., P 12, Maryam Ave., Golestan 5 St., Heravi Sq., Pasdaran
City
Tehran
Province
Tehran
Postal code
1667863716
Phone
+98 21 2294 4094
Email
sussanramsari@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Sussan Ramsari
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 5, P 12, Maryam Ave, Golestam 5 St., Heravi Sq., Pasdaran
City
Tehran
Province
Tehran
Postal code
1667863716
Phone
+98 82122944094
Email
sussanramsari@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Alzahra University
Full name of responsible person
Sussan Ramsari
Position
Nutritionist
Latest degree
Master
Other areas of specialty/work
Nutrition
Street address
No 5, P 12, Maryam Ave, Golestam 5 St., Heravi Sq., Pasdaran
City
Tehran
Province
Tehran
Postal code
1667863716
Phone
+98 21 2294 4094
Email
sussanramsari@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
Yes - There is 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
Title and more details about the data/document
I haven't decided yet
When the data will become available and for how long
I haven't decided yet
To whom data/document is available
I haven't decided yet
Under which criteria data/document could be used
I haven't decided yet
From where data/document is obtainable
I haven't decided yet
What processes are involved for a request to access data/document
I haven't decided yet
Comments
I haven't decided yet
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