Effect of Aerobic Training, Calorie Restriction and Combination of Aerobic Training and Calorie Restriction on Hormonal and Metabolic Factors Related to Fatty Liver in Postmenopausal Women with NAFLD
Design
Randomised, parallel group trial with blinded outcome assessment.
Settings and conduct
The study will be carried out on patients of Gastroenterologist clinic and blindness in participants
Participants/Inclusion and exclusion criteria
Inclusion Criteria : Overweight Postmenopausal Women with NAFLD
Exclusion Criteria : 1. Weight Changing over 2 kg over the past 6 months; 2. Smoking; 3. Alcohol consumption more than 30 grams per day; 4. Use of supplementary pills and special dietary ; 5. Cardiovascular disease And respiratory diseases; 6. orthopedic problems; 7. prohibition of participation in sports activities; and 8. regular exercise in the past year (at least 3 days a week).
Intervention groups
Aerobic Training - Calorie Restriction - Aerobic Training with Calorie Restriction
Main outcome variables
Estrogen Levels , Glucose Levels , Insulin Levels, Liver Enzymes, Fetuin A Levels, Lipid profile and Hepatic Fat
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190408043203N1
Registration date:2019-04-30, 1398/02/10
Registration timing:registered_while_recruiting
Last update:2019-04-30, 1398/02/10
Update count:0
Registration date
2019-04-30, 1398/02/10
Registrant information
Name
Elham Akbarzadeh
Name of organization / entity
The University of Guilan
Country
Iran (Islamic Republic of)
Phone
+98 13 3369 0485
Email address
akbarzadeh.elham@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-04-21, 1398/02/01
Expected recruitment end date
2019-05-10, 1398/02/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of Aerobic Training and Calorie Restriction on Hormonal and Metabolic Factors Related to Fatty Liver in Postmenopausal Women with NAFLD
Public title
Effect of Aerobic Training and Calorie Restriction on Hormonal and Metabolic Factors Related to Fatty Liver in Postmenopausal Women with NAFLD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Overweight Postmenopausal Women with NAFLD
Exclusion criteria:
Weight Changing over 2 kg over the past 6 months
Smoking
Alcohol consumption more than 30 grams per day
Use of supplementary pills and special dietary
Cardiovascular disease And respiratory diseases
Orthopedic problems
Prohibition of participation in sports activities
Regular exercise in the past year (at least 3 days a week)
Age
From 45 years old to 70 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are randomly assigned with random number table in one of the three groups and will receive intervention of the same group
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
Ethics committee of Guilan University of Medical Sciences
Street address
Rasht, Namjoo St, Shahid Siadati Avenue, in front of the 17th Shahrivar Hospital, vice chancellery for research and technology
City
Rasht
Province
Guilan
Postal code
4188794755
Approval date
2019-03-09, 1397/12/18
Ethics committee reference number
IR.GUMS.REC.1397.482
Health conditions studied
1
Description of health condition studied
Non-Alcoholic Fatty Liver Disease
ICD-10 code
K75.81
ICD-10 code description
Nonalcoholic steatohepatitis (NASH)
Primary outcomes
1
Description
Estrogen Levels
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
2
Description
Insulin Resistance Index
Timepoint
Before and after intervention
Method of measurement
Insulin Resistance Index Formula with Insulin and Glucose Levels
3
Description
Hepatic Fat
Timepoint
Before and after intervention
Method of measurement
elastography
4
Description
Glucose Levels
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
5
Description
Insulin Levels
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
6
Description
Liver Enzymes
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
7
Description
Fetuin A Levels
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
8
Description
Lipid profile
Timepoint
Before and after intervention
Method of measurement
Blood Sample Analysis
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1st: moderate intensity Aerobic Training (running on treadmill with 65% of HRmax), 4 days per week - 12 weeks
Category
Treatment - Other
2
Description
Intervention group 2nd: Calorie Restriction (25 % reduction of daily energy requirement), 4 days per week - 12 weeks
Category
Treatment - Other
3
Description
Intervention group 3rd: Aerobic Training with Calorie Restriction - 4 days per week - 12 weeks
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Gastroenterologist Clinic
Full name of responsible person
Afshin Shafaghi
Street address
Rasht - Golsar crossroad - in front of boostan Park - Dr.Afshin Shafaghi Clinic
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3373 6122
Email
Drafshinshafaghi@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice-Chancellor for Research of University of Guilan
Full name of responsible person
Seyyed Ziaeddin Mirhosseini
Street address
Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science
City
Rasht
Province
Guilan
Postal code
4199613776
Phone
+98 13 3369 0338
Email
szmirhoseini@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice-Chancellor for Research of University of Guilan
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
The University of Guilan
Full name of responsible person
Elham Akbarzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Physiology
Street address
Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0485
Email
akbarzadeh.elham@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Elham Akbarzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Physiology
Street address
Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0485
Email
akbarzadeh.elham@gmail.com
Web page address
https://fe.guilan.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
The University of Guilan
Full name of responsible person
Elham Akbarzadeh
Position
PhD Student
Latest degree
Master
Other areas of specialty/work
Sport Phyisology
Street address
Rasht, Khalij Pars Highway(5th Kilometer of Ghazvin Road), University of Guilan, Faculty of Exercise Science
City
Rasht
Province
Guilan
Postal code
۴۱۹۹۶۱۳۷۷۶
Phone
+98 13 3369 0485
Email
akbarzadeh.elham@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data of measured variables can be shared without identifying subjects
When the data will become available and for how long
Starting at March 2020
To whom data/document is available
Researchers
Under which criteria data/document could be used
Scientific use in improving and comparing with other researches is allowed
From where data/document is obtainable
The applicant must contact the researcher's email address (Elham Akbarzadeh)
Email: akbarzadeh.elham@gmail.com
What processes are involved for a request to access data/document
Applicants must send the reasons for requesting the documentation to the researcher's e-mail address. The researcher, after examining the reasons and, if the reasons are sufficient, will send the documents for applicant up to 4 work days.