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IRCT20221120056548N10 IRCT 2023-07-25 Vice President of Research at Danesh Alborz University The effect of exercise and green tea consumption on non-alcoholic fatty liver 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. 2023-07-29 anticipated 60 Complete https://irct.ir/trial/69767 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Education/Guidance, 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. N/A Non-alcoholic fatty liver. Intervention 1: 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. Intervention 2: Control group: This group is not subjected to any exercise intervention and supplement consumption. Yes - There is a plan to make this available What will be shared: All data is potentially shareable after de-identifying individuals When: The access period starts 6 months after the results are published To whom: It will be available for researchers working in academic and scientific institutions. Conditions: If the intellectual rights are preserved, the data can be sent to the researchers. Where to obtain: Email address: saeidshamlou9092@gmail.com How to obtain: Submission of a written request (one week) Comments:
public Saeid Shamlou Kazemi
Mahdiyeh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3221 0929 saeidshamlou9092@gmail.com Bu-Ali Sina University scientific Saeid Shamlou Kazemi
Mahdiyeh Ave
Hamadan Iran (Islamic Republic of) 6517838695 +98 81 3221 0929 saeidshamlou9092@gmail.com Bu-Ali Sina University Iran (Islamic Republic of) Non-alcoholic fatty liver disease being menopausal 50 to 65 years 50 years 65 years Female History of cardiovascular disease K76.0 Fatty (change of) liver, not elsewhere classified Treatment - Other Treatment - Other 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. Control group: This group is not subjected to any exercise intervention and supplement consumption. 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. 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. Vice President of Research at Danesh Alborz University Approved 2023-06-21 Ethics Committee of Sport Sciences Research Institute Fifth Alley, Mir Emad Ave., Ostad Motahari Ave Tehran Tehran Iran (Islamic Republic of)