Comparison of Low Calorie Diet alone and combined with Yoga training on basal metabolic,Anthropometric indices, Adiponectin and Leptin in Overweight and Obese Women
Determination and comparison of the effects of low calorie diet alone and combined with Yoga training on basal metabolic rate, Anthropomentric indices, and Adiponection and Leptin
Design
In this study, 36 overweight and obese women who are eligible for inclusion criteria of the study are selected, and the participants are divided into two groups of diet and yoga, with each participant assigned a code.
Settings and conduct
The target group is overweight and obese women who are randomly assigned into two groups of diet alone and combined with Yoga and followed for 2 months. In diet group, 500 Kilo-calorie will be reduced after calculating the individual's energy requirement and in the yoga and diet group, 7 days workshop will be done and after that Hatta Yoga will be performed every day under the supervision of coach. In this group, a 300 Kilo-calorie reduced diet, and 200 calories from the yoga exercise will be designed. Through an indirect calorie meter, the duration of the yoga will be determined to find 200 Kilo-calorie expenditure.
Participants/Inclusion and exclusion criteria
Inclusion criteria: overweight and obese women, age range between 30 and 55 years old
Exclusion criteria: diabetes, hypertension, and coronary heart disease, thyroid disorders, using dietary supplements that have effect on metabolism, smoking.
Intervention groups
intervention group: Yoga and diet
control group: diet
Comparison of Low Calorie Diet alone and combined with Yoga training on basal metabolic,Anthropometric indices, Adiponectin and Leptin in Overweight and Obese Women
Public title
Comparison of Diet with Yoga accompanying Diet on body Metabolism in Obese people
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
age30-55
Female
25<BMI
Failure to follow a continuous exercise program
Lack of Pregnancy, lactation and menopause
Lack of Hypertension, Diabetes, Coronary artery Disease, stroke, thyroid disorders, Mental disorders
Lack of weight loss over 5% in the last 6 months
Failure to follow a special Diet plan
Non-use of statin drugs, beta-blockers, fluorescent Drugs
Lack of unhealthy weight
Exclusion criteria:
Smoking and And tobacco
Eating any supplement that has an Effect on the Metabolism
Failure to follow the plan
Age
From 30 years old to 55 years old
Gender
Female
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
36
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will done using 6 subjects per block. Statistical software (Minitab) will use to perform randomized block. For the nature of intervention (Yoga+diet and diet), blinding will not perform.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
I thics committee of Ahvaz University of Medical Sciences
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Approval date
2017-11-24, 1396/09/03
Ethics committee reference number
IR.AJUMS.REC.1396.735
Health conditions studied
1
Description of health condition studied
Obesity
ICD-10 code
E66.0
ICD-10 code description
0besity due to excesscalories
Primary outcomes
1
Description
Basal Metabolic Rate
Timepoint
Before and after intervention
Method of measurement
Indirect calorie meter
2
Description
Leptin
Timepoint
Before and after intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)
3
Description
Adiponectin
Timepoint
Before and after intervention
Method of measurement
enzyme-linked immunosorbent assay (ELISA)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Yoga and diet
Category
Treatment - Other
2
Description
Control group: Diet
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ahvaz Jundishapur University of Medical Science
Full name of responsible person
Sima Jafarirad
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
sjafarirad@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ahvaz University of Medical Sciences
Full name of responsible person
Mohammad Badavi
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8383
Email
badavi-m@ajums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ahvaz Jundishapur University of Medical Sciences
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
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Faredeh Yazdanparast
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
yazdanparast.f@ajums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Sima Jafarirad
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
sjafarirad@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Ahvaz Jundishapur University of Medical Sciences
Full name of responsible person
Faredeh Yazdanparast
Position
Master of Sciences student
Latest degree
Bachelor
Other areas of specialty/work
Nutrition
Street address
Golestan Highway
City
Ahvaz
Province
Khouzestan
Postal code
6135715794
Phone
+98 61 3373 8317
Email
yazdanparast.f@ajums.ac.ir
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
A part of data will be able to share
When the data will become available and for how long
From 2019
To whom data/document is available
Researchers in universities
Under which criteria data/document could be used
Only for personal studying, not sharing
From where data/document is obtainable
via email: jafarirad-s@ajums.ac.ir
What processes are involved for a request to access data/document
a valid confirmation letter form university which the researcher works in it and then must be confirmed by Ahvaz Jundishapur University of Medical Sciences