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IRCT20230919059465N1 IRCT 2024-02-17 Islamic Azad University Investigating the effect of 12 weeks of HIFT and Ginkgo biloba consumption on serum levels of inflammatory indicators and antioxidant defense The effect of 12 weeks of high-intensity functional training (HIFT) and Ginkgo biloba consumption on serum levels of inflammatory indicators, antioxidant defense and physical performance in Yazd firefighters. 2024-02-20 anticipated 48 Complete https://irct.ir/trial/73893 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Factorial, Purpose: Health service research, Randomization description: In the current research, the randomization method will be performed using the random sequence generation software method. Random allocation software is one of these software’s. In addition to simple randomization, random sequence generation software’s are capable of generating random sequences by block method. The randomization unit is individual. In the following, the concealment of random allocation is done by using sealed and opaque envelopes in a random sequence, which is called the SNOSE method. Finally, in the process of randomization in the present study, the person involved in creating the randomization program will be separate from other researchers to reduce possible bias, Blinding description: The training place of the participants who are in the four groups will be separate from each other, the participants will not know the type and content of the supplement consumed. The data analyst will be unaware of the type of data that is related to which group and will not know what type of intervention the data is related to. N/A Inflammatory status and antioxidant defense. Intervention 1: The first intervention: consists of performing high-intensity functional training (HIFT). The subjects of this intervention (12 people) perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload.. HIFT is a combination of aerobic and resistance training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session. Intervention 2: The second intervention: consists of performing high-intensity functional training (HIFT) with Ginkgo biloba supplement (80 mg).The subjects of this intervention (12 people) will perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload and will receive Ginkgo biloba (80 mg) in the form of two capsules once a day along with training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session. Intervention 3: The third intervention: Ginkgo biloba supplement (80 mg). The subjects of this intervention (12 people) will receive gincobiloba supplement (80 mg) on Saturday, Sunday, Tuesday and Wednesday in the form of two capsules per day for 12 weeks. Ginkgo biloba capsule contains 80 mg of standard Ginkgo biloba, including 19.2 mg of flavonoid glycoside (24%), 4.8 mg of terpene lactone (6%) and other substrates such as maltodextrin, microcrystalline cellulose and magnesium stearate. Intervention 4: Control :The control group (12 people) does not participate in any intervention and performs its normal daily activities during the study (12 weeks). They will not participate in training programs and physical activities and will follow their normal daily diet. The placebo capsule will also contain microcrystalline cellulose, magnesium stearate and maltodextrin, which will be supplied in the same form and color as the supplement. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hamid Sedaghat
No. 228, Alley Shahid Rajaei, Shahid Beheshti Blvd, Yazd, IRAN.
Yazd Iran (Islamic Republic of) 8916715188 +98 35 3623 5396 hsedaghat9194@gmail.com Islamic Azad University scientific Hasan Naghizadeh
Ardakan University, Ayatollah Khatami Blvd, Ardakan, IRAN.
Ardakan Iran (Islamic Republic of) 95491-89518 +98 35 3390 0000 naghizadeh2011@ardakan.ac.ir Ardakan University Iran (Islamic Republic of) All firefighters who are in the operational line, have more than 3 years of work experience, age range of 25 to 50 years, not suffering from specific physiological and metabolic diseases, not taking special dietary and sports supplements. 1382 years 1352 years Male Work experience of less than 3 years, age less than 25 years and more than 50 years, suffering from a disabling disease from participating in training, taking special dietary and sports supplements -- -- Other Other Other Placebo The first intervention: consists of performing high-intensity functional training (HIFT). The subjects of this intervention (12 people) perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload.. HIFT is a combination of aerobic and resistance training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session. The second intervention: consists of performing high-intensity functional training (HIFT) with Ginkgo biloba supplement (80 mg).The subjects of this intervention (12 people) will perform HIFT exercises for 12 weeks and 4 sessions per week based on the principle of overload and will receive Ginkgo biloba (80 mg) in the form of two capsules once a day along with training. Aerobic exercise will be performed with an intensity of 60 to 85% of the target heart rate. Resistance training will be performed with 70 to 90% of a maximum repetition. 48 hours before the start of the first training session, the subjects will go to a gym equipped with standard sports equipment to measure anthropometric characteristics, physical and physiological composition. Blood sampling will be done 24 hours before the first training session. The third intervention: Ginkgo biloba supplement (80 mg). The subjects of this intervention (12 people) will receive gincobiloba supplement (80 mg) on Saturday, Sunday, Tuesday and Wednesday in the form of two capsules per day for 12 weeks. Ginkgo biloba capsule contains 80 mg of standard Ginkgo biloba, including 19.2 mg of flavonoid glycoside (24%), 4.8 mg of terpene lactone (6%) and other substrates such as maltodextrin, microcrystalline cellulose and magnesium stearate. Control :The control group (12 people) does not participate in any intervention and performs its normal daily activities during the study (12 weeks). They will not participate in training programs and physical activities and will follow their normal daily diet. The placebo capsule will also contain microcrystalline cellulose, magnesium stearate and maltodextrin, which will be supplied in the same form and color as the supplement. Lipocalin-2. Timepoint: Two stages: before the start of the study and after the end of 12 weeks of interference. Method of measurement: Valid and standard lipocalin-2 laboratory kit. Interleukin-8 (IL-8). Timepoint: Two stages: before the start of the study and after the end of 12 weeks of intervention. Method of measurement: Valid and standard IL-8 laboratory kit. Interleukin-1beta (IL-1β). Timepoint: Two stages: before the start of the study and after the end of 12 weeks of intervention. Method of measurement: Valid and standard IL-1β laboratory kit. Superoxide desmutase (SOD). Timepoint: Two stages: before the start of the study and after the end of 12 weeks of intervention. Method of measurement: Valid and standard SOD laboratory kit. Catalase (CAT). Timepoint: Two stages: before the start of the study and after the end of 12 weeks of intervention. Method of measurement: Valid and standard CAT laboratory kit. Isfahan, Islamic Azad University, Khorasgan branch Approved 2023-10-31 Ethics Committee of Islamic Azad University of Isfahan, Khorasgan branch University Blvd, Arghwanieh, East J Street, Isfahan, IRAN Isfahan Isfehan Iran (Islamic Republic of)