The effect of eight weeks of combined exercises and green tea consumption on the level of sirtuin 1 and liver enzymes in patients with non-alcoholic fatty liver disease.
Determining the effect of eight weeks of combined exercises and green tea consumption on the level of sirtuin 1 and liver enzymes 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
Exercises and supplements group: in the exercises group, the samples are subjected to combined exercises, and the supplement group also consumes green tea, and finally, the exercise group along with consumption of green tea, which implements both at the same time. The control group is not subjected to any intervention.
Main outcome variables
Non-alcoholic fatty liver, sirtuin 1, some liver enzymes
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20221120056548N10
Registration date:2023-07-25, 1402/05/03
Registration timing:prospective
Last update:2023-07-25, 1402/05/03
Update count:0
Registration date
2023-07-25, 1402/05/03
Registrant information
Name
Saeid Shamlou kazemi
Name of organization / entity
Bu-Ali Sina university
Country
Iran (Islamic Republic of)
Phone
+98 912 859 7297
Email address
saeidshamlou9092@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-07-29, 1402/05/07
Expected recruitment end date
2023-08-04, 1402/05/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of eight weeks of combined exercises and green tea consumption on the level of sirtuin 1 and liver enzymes in patients with non-alcoholic fatty liver disease.
Public title
The effect of exercise and green tea consumption on non-alcoholic fatty liver
Purpose
Education/Guidance
Inclusion/Exclusion criteria
Inclusion criteria:
Non-alcoholic fatty liver disease
being menopausal
50 to 65 years
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.1402.063
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 level of liver enzymes in their blood has decreased.
Timepoint
Before and after interventions
Method of measurement
By measuring the 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 Zellbio kit made in Germany
Intervention groups
1
Description
Intervention group: Sports intervention includes 8 weeks of combined exercises (selected aerobic and resistance exercises). According to the instructions of the American College of Sports Medicine (ACSM), the participants start training three times a week for fifty minutes, and the intensity and duration of the training is increased during 8 weeks. All exercises are performed under the supervision of a sports physiology specialist and in the health sports clinic. For aerobic exercise, participants choose to exercise on a treadmill or bicycle ergometer. Aerobic training sessions start from 20 minutes and with an intensity of 60% of the maximum heart rate in the first and second week and increase to 30 minutes and up to 70% of the maximum heart rate in the 8th week. During the training, the heart rate is monitored by a Polar T31 oy pacemaker. Resistance training begins with one set of 15 repetitions for each movement in the first two weeks, and finally the intensity of the training is increased to two or three sets of 10-120 repetitions. It increases in week 8. All resistance exercises are performed by means of gym machines and include chest press, leg press, cable underarm, cable front arm and cable back arm. 500 mg capsules of green tea were prescribed twice a day for eight weeks. Therefore, in this recipe, we use Kam Green green tea tablets, which contain 450 mg of green tea, twice a day for eight weeks. The third group implements both interventions at the same time.
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 street
City
Hamadan
Province
Hamadan
Postal code
6517838695
Phone
+98 81 3221 0929
Fax
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
No - There is not 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