The effect of eight weeks of high intensity interval training (HIIT), resistance training and consumption of artichoke extract on the level of sirtuin 1 and team enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients with non-alcoholic fatty liver disease
Determining the effect of eight weeks of intense interval training (HIIT), resistance training and consumption of artichoke extract on the level of sirtuin 1 and liver enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients with non-alcoholic fatty liver disease.
Design
Clinical trial with control group, with parallel groups, randomized, on 60 patients. Randomization by the method of equal blocks (15 blocks of 4) in which a number of intervention people and a number of comparison people are included in each block.
Settings and conduct
By referring to Hamedan Ba'ath Hospital, eligible people were identified and placed in the intervention groups using equal blocks randomization (15 blocks of 4). Then, people will go to the sports club for training intervention and perform exercises and supplements for 8 weeks. And before and 24 hours after exercise interventions, blood samples are taken from people to be measured in the laboratory.
Participants/Inclusion and exclusion criteria
Entry conditions: suffering from non-alcoholic fatty liver disease
Conditions of non-entry: inability to practice
Intervention groups
Exercise and supplement group: In the exercise group, the samples are subjected to high-intensity and resistance intermittent exercises, and the supplement group consumes artichoke extract. The control group is not subjected to any intervention.
The effect of eight weeks of high intensity interval training (HIIT), resistance training and consumption of artichoke extract on the level of sirtuin 1 and team enzymes aspartate aminotransferase (AST) and alanine aminotransferase (ALT) in patients with non-alcoholic fatty liver disease
Public title
The effect of exercise and artichoke extract on non-alcoholic fatty liver
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Non-alcoholic fatty liver disease
being menopausal
Exclusion criteria:
History of cardiovascular disease
Age
From 50 years old to 65 years old
Gender
Female
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this randomization, the method of equal blocks (15 blocks of 4) has been used, in which a number of intervention people and a number of comparison people are included in each block, and we have allocated them to different groups. The method and tool of block random sequence generation has been done using https://www.sealedenvelope.com/simple-randomiser/v1/lists.
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 Sport Sciences Research Institute
Street address
Fifth Alley, Mir Emad Ave., Ostad Motahari Ave
City
Tehran
Province
Tehran
Postal code
1474674646
Approval date
2023-06-21, 1402/03/31
Ethics committee reference number
IR.SSRC.REC.1402.078
Health conditions studied
1
Description of health condition studied
Non-alcoholic fatty liver
ICD-10 code
K76.0
ICD-10 code description
Fatty (change of) liver, not elsewhere classified
Primary outcomes
1
Description
The percentage of people whose liver enzymes have decreased.
Timepoint
Before and after interventions
Method of measurement
By measuring the liver enzymes in the blood in the laboratory
Secondary outcomes
1
Description
The percentage of people in whom the level of sirtuin 1 is increased.
Timepoint
Before and after interventions
Method of measurement
Using ELISA method and Zelbio kit made in Germany
Intervention groups
1
Description
Intervention group: Intense interval training was performed for 8 weeks and four sessions per week and each session lasted for 60 minutes (15 minutes of warm-up + 30 minutes of interval training + 15 minutes of cooling) with an intensity of 80-85% of the maximum heart rate. They performed high-intensity resistance training of 7 movements 3 times a week. In the first two weeks, they did one maximum repetition and 6 repetitions with 90% intensity, in the third to fifth week with 95% maximum repetition and 4 repetitions, and the last three weeks with 100% ability and two repetitions. The amount of rest between sets was 1 minute and between stations was 2 to 3 minutes. For each subject in each station, which included barbell chest press, front shoulder with barbell, front underarm lat, front arm with cable hand, back arm with cable, front thigh with machine and back thigh with machine, the amount of weight It was found that it is usually able to lift less than 10 times. Artichoke extract is consumed in the following way. The parts of this plant were dried in the shade and crushed with the help of a grinder and turned into powder. The chopped leaves of the dried artichoke plant (fluffy silver leaves) were given to the study subjects in the form of packages in the required number, and they were asked to take them for 45 days, in two occasions (at night before going to bed; that is, two hours after eating dinner and the second time in the morning fasting one hour before breakfast) brew a tablespoon of plant leaves with a glass of boiling water for 20 minutes on indirect heat and at a temperature of 80 degrees Celsius.
Category
Treatment - Other
2
Description
Control group: This group is not subjected to any exercise intervention and supplement consumption.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Besat Hospital
Full name of responsible person
Saeid Shamlou Kazemi
Street address
Shahid Beheshti Blvd
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3264 0020
Email
saeidshamlou9092@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice President of Research at Danesh Alborz University
Full name of responsible person
Dr. Mohammad Tahernia
Street address
Danesh Alborz University, Abyek
City
Qazvin
Province
Qazvin
Postal code
6517838695
Phone
+98 937 125 7977
Email
tahernia2004@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice President of Research at Danesh Alborz University
Proportion provided by this source
10
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
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Bu-Ali Sina University
Full name of responsible person
Saeid Shamlou Kazemi
Position
Student
Latest degree
Master
Other areas of specialty/work
Sport Medicine
Street address
Mahdiyeh Ave
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Email
saeidshamlou9092@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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Yes - There is 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
Yes - There is a plan to make this available
Title and more details about the data/document
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts 6 months after the results are published
To whom data/document is available
It will be available for researchers working in academic and scientific institutions.
Under which criteria data/document could be used
If the intellectual rights are preserved, the data can be sent to the researchers.
From where data/document is obtainable
Email address: saeidshamlou9092@gmail.com
What processes are involved for a request to access data/document