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IRCT20251121068065N7 IRCT 2026-06-21 Islamic Azad University, Bushehr Branch The Effect of 8 Weeks of High-Intensity Interval Training (HIIT) and Apple Cider Vinegar Consumption on Liver Enzyme Levels in Overweight Women The Effect of 8 Weeks of High-Intensity Interval Training (HIIT) and Apple Cider Vinegar Consumption on Liver Enzyme Levels in Overweight Women 2026-07-11 anticipated 40 Complete https://irct.ir/trial/91003 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: After baseline assessment, participants will be randomly allocated to four groups (HIIT, apple cider vinegar, HIIT plus apple cider vinegar, and control) using a simple randomization method based on a random number table. The allocation sequence will be prepared in advance, and group assignment will be implemented using sequentially numbered, sealed, opaque envelopes to ensure allocation concealment. After enrollment, each participant will be assigned to a group by opening the next available envelope, Blinding description: This study is single-blind. Outcome assessors will be blinded to group allocation throughout the study. Participants will also be blinded to the study hypothesis and the comparative objectives of the intervention, while the researchers involved in the intervention delivery will not be blinded due to the nature of the study. 2 Overweight (Overweight in women). Intervention 1: Control group: The control group will receive a placebo solution similar in appearance and taste and will not participate in a structured exercise program, maintaining their usual daily activities. Intervention 2: Intervention group: The first intervention group will perform an 8-week high-intensity interval training program, three sessions per week, with each 20-minute session including warm-up, repeated high-intensity intervals (90–95% HRpeak) interspersed with recovery periods, and cool-down. The subjects’ heart rate will be monitored using a Polar heart rate monitor. Intervention 3: Intervention group: The second intervention group will receive daily intake of 10 mL apple cider vinegar (5% acetic acid) diluted in 250 mL water for 8 weeks. Intervention 4: Intervention group: The third group will receive a combination of an 8-week high-intensity interval training program and daily consumption of 10 mL of apple cider vinegar. 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 No more information available.
public Dr. Elham Dehghan
Velayat Building (Islamic Azad University, Bushehr Branch), Beginning of Shahid Raees Ali Delvari Boulevard, Municipality Square, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 7515895496 +98 917 771 0144 Elham.dehghan@iau.ac.ir Islamic Azad University, Bushehr Branch scientific Dr. Elham Dehghan
Velayat Building (Islamic Azad University, Bushehr Branch), Beginning of Shahid Raees Ali Delvari Boulevard, Municipality Square, Bushehr, Iran
Bushehr Iran (Islamic Republic of) 7515895496 +98 917 771 0144 Elham.dehghan@iau.ac.ir Islamic Azad University, Bushehr Branch Iran (Islamic Republic of) Women aged 21–29 years. Body mass index (BMI) between 25 and 29.9 kg/m². Residents of Bushehr. Stable body weight during the past 6 months. Stable body weight during the past 6 months. No use of nutritional supplements or drugs affecting liver function in the last 6 months. No history of chronic diseases (e.g., diabetes, cardiovascular, renal, or hepatic diseases). Ability to perform moderate-to-vigorous physical activity based on physician approval and fitness assessment. 21 years 29 years Female Absence from more than two training sessions. Non-adherence to supplement or placebo regimen. Occurrence of injury or medical condition preventing continuation of the study. Failure to attend post-test assessment or final blood sampling. E66.3 Overweight Treatment - Other Treatment - Other Treatment - Other Treatment - Other Control group: The control group will receive a placebo solution similar in appearance and taste and will not participate in a structured exercise program, maintaining their usual daily activities. Intervention group: The first intervention group will perform an 8-week high-intensity interval training program, three sessions per week, with each 20-minute session including warm-up, repeated high-intensity intervals (90–95% HRpeak) interspersed with recovery periods, and cool-down. The subjects’ heart rate will be monitored using a Polar heart rate monitor. Intervention group: The second intervention group will receive daily intake of 10 mL apple cider vinegar (5% acetic acid) diluted in 250 mL water for 8 weeks. Intervention group: The third group will receive a combination of an 8-week high-intensity interval training program and daily consumption of 10 mL of apple cider vinegar. Serum alanine aminotransferase (ALT) level. Timepoint: Alanine aminotransferase levels will be assessed at two time points: (1) baseline (before the intervention) and (2) forty-eight hours after completion of the 8-week intervention period. Method of measurement: Fasting venous blood samples will be collected between 7:00 and 8:00 a.m. A 5 mL blood sample will be drawn from the cubital vein of the left arm by a trained nurse at each time point. Samples will be allowed to clot at room temperature for 20 minutes, then centrifuged for 10 minutes at 3000–3500 rpm. The separated serum will be aliquoted into microtubes and stored at −80°C. Serum alanine aminotransferase levels will be measured using commercial diagnostic kits (Pars Azmoun, Iran) with a sensitivity of 2–4 IU/L and analyzed by an autoanalyzer using the photometric method. Serum aspartate aminotransferase (AST) level. Timepoint: Aspartate aminotransferase levels will be assessed at two time points: (1) baseline (before the intervention) and (2) forty-eight hours after completion of the 8-week intervention period. Method of measurement: Fasting venous blood samples will be collected between 7:00 and 8:00 a.m. A 5 mL blood sample will be drawn from the cubital vein of the left arm by a trained nurse at each time point. Samples will be allowed to clot at room temperature for 20 minutes, then centrifuged for 10 minutes at 3000–3500 rpm. The separated serum will be aliquoted into microtubes and stored at −80°C. Serum aspartate aminotransferase levels will be measured using commercial diagnostic kits (Pars Azmoun, Iran) with a sensitivity of 2–4 IU/L and analyzed by an autoanalyzer using the photometric method. Serum alkaline phosphatase (ALP) level. Timepoint: Serum alkaline phosphatase (ALP) level will be assessed at two time points: (1) baseline (before the intervention) and (2) forty-eight hours after completion of the 8-week intervention period. Method of measurement: Fasting venous blood samples will be collected between 7:00 and 8:00 a.m. A 5 mL blood sample will be drawn from the cubital vein of the left arm by a trained nurse at each time point. Samples will be allowed to clot at room temperature for 20 minutes, then centrifuged for 10 minutes at 3000–3500 rpm. The separated serum will be aliquoted into microtubes and stored at −80°C. Serum alkaline phosphatase (ALP) levels will be measured using commercial diagnostic kits (Pars Azmoun, Iran) with a sensitivity of 2–4 IU/L and analyzed by an autoanalyzer using the photometric method. Islamic Azad University, Bushehr Branch Approved 2025-09-28 Research Ethics Committee of Bushehr University of Medical Sciences Bushehr University of Medical Sciences, Cinema Street, Bushehr. Bushehr Boushehr Iran (Islamic Republic of)