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IRCT20220828055811N1 IRCT 2022-10-10 The University of Shahid Beheshti Effect of high-intensity interval training on obesity The effect of high-intensity interval training and beta-alanine supplementation on the basal levels and acute exercise response of oxidative-inflammatory markers in overweight/obese men 2022-10-22 anticipated 28 Complete https://irct.ir/trial/65723 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Basic scienece, Randomization description: Subjects will be divided individually into four groups by the simple randomization method and with the help of the randomization tool available on the GraphPad website (www.graphpad.com), Blinding description: All subjects participating in the study will receive identical capsules, which will have the same appearance. Dextrose will be used as the placebo due to its identical appearance to beta-alanine. Subjects will not be informed of the type of supplement they are taking until the end of the study. All the capsules will be prepared by someone outside the study and will be given to the subjects by the same person, and the researchers will not know the type of capsule consumed by the subjects. Also, the grouping and randomization of subjects will be done by someone outside the study. The main researcher and the data evaluator will not know about the grouping of subjects until the end of the study. The analyzer will also analyze the data without knowing which data belongs to each group. Then it will be clear which data belongs to each group. N/A Obesity. Intervention 1: First intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals). Intervention 2: Second intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal). Intervention 3: Third intervention group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals). Intervention 4: Control group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal). Yes - There is a plan to make this available What will be shared: Only primary and secondary data will be presented as an article. When: The access period starts six months after the results are published. To whom: The present research data will be available to researchers in academic and scientific institutions in the form of general statistical data, or people who are also engaged in the industry can apply for it after the publication of the article. Conditions: The present study's data will be made available to others in the form of general statistics (without reference to the raw data of the subjects) with the researchers' permission. Where to obtain: Applicants can contact me by phone, WhatsApp, or email. How to obtain: After contacting me and reviewing the request, it will be reviewed if necessary. Comments:
public Mohamad Saber Ebrahimi Zarandi
Boys' dormitory of Shahid Beheshti University, Daneshjoo Blvd., Shahid Shahriari Square, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 5824 m.ebrahimizarandi@mail.sbu.ac.ir The University of Shahid Beheshti scientific Mohamad Saber Ebrahimi Zarandi
Boys' dormitory of Shahid Beheshti University, Daneshjoo Blvd., Shahid Shahriari Square, Evin, Tehran
Tehran Iran (Islamic Republic of) 1983969411 +98 21 2990 5824 m.ebrahimizarandi@mail.sbu.ac.ir The University of Shahid Beheshti Iran (Islamic Republic of) Men Body mass index from 25 to 35 kilogram per square meter All persons with at least 25 percent body fat Inactive Age 18 to 35 years 18 years 35 years Male Smoking Having an underlying disease Blood Glucose above 110 mg per liter; Hematocrit below 35% Hemoglobin below 13 g/dl WBC count more than 11,000 per microliter E66 Overweight and obesity Prevention Prevention Prevention Placebo First intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals). Second intervention group: Consumption of beta-alanine supplement from My Protein company for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal). Third intervention group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) and performing three sessions of high-intensity interval training (10 one-minute intervals with 80% of maximum aerobic power and one-minute recovery with 20% of maximum aerobic power between intervals). Control group: Consumption of placebo (Dextrose) for six weeks in the amount of 6.4 grams daily in the form of 8 capsules of 0.8 grams (two capsules in each main meal) Serum tumor necrosis factor alpha (TNFα). Timepoint: At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session. Method of measurement: Using ELISA method and kit made in Germany (LDN company). Serum high-sensitivity C-reactive protein (hs-CRP). Timepoint: At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session. Method of measurement: Using ELISA method and kit made in Germany (LDN company). Serum interleukin 10. Timepoint: At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session. Method of measurement: Using ELISA method and kit made in Germany (LDN company). Serum Malondialdehyde (MDA). Timepoint: At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session. Method of measurement: Using Fluorometric method and kit made in Iran (KPG company). Serum total antioxidant capacity. Timepoint: At the beginning of the study, six weeks after the start of the supplement and exercises and 30 minutes after the end of the last training session. Method of measurement: Using Fluorometric method and kit made in Iran (KPG company). Body Composition. Timepoint: At the beginning of the study and six weeks after the start of the supplement and training. Method of measurement: Using inbody 770 machine. High Density Lipoprotein (HDL). Timepoint: At the beginning of the study and six weeks after the start of the supplement and training. Method of measurement: Using Hitachi 717 machine and kit made in Iran. Low Density Lipoprotein (LDL). Timepoint: At the beginning of the study and six weeks after the start of the supplement and training. Method of measurement: Using Hitachi 717 machine and kit made in Iran. Triglyceride (TG). Timepoint: At the beginning of the study and six weeks after the start of the supplement and training. Method of measurement: Using Hitachi 717 machine and kit made in Iran. Cholesterol. Timepoint: At the beginning of the study and six weeks after the start of the supplement and training. Method of measurement: Using Hitachi 717 machine and kit made in Iran. The University of Shahid Beheshti Approved 2022-05-14 Ethics Committee of Shahid Beheshti University Shahid Beheshti University, Shahid Shahriari Square, Evin, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)