]>
IRCT20251104067881N1 IRCT 2025-11-21 Alzahra University, Tehran Studying the effect of high-intensity functional training with terminalia chebula extract in women with metabolic syndrome Mets. TC. HIFT. The Combined effect of high-intensity functional training and terminalia chebula extract on liver enzymes, metabolic syndrome indices, and physical fitness factors in women with metabolic syndrome 2026-02-09 anticipated 60 Complete https://irct.ir/trial/87306 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Basic scienece, Other design features: In the present study, a new exercise program along with a herbal supplement that has no side effects is applied to people with metabolic syndrome, Randomization description: In this study, after initial recruitment and screening, eligible participants (women with metabolic syndrome) will enter the allocation phase. First, blood tests and measurements of required factors will be performed according to the protocol. Then, all eligible individuals, without any priority, precedence, or specific criteria for group entry, will be equally and with equal probability assigned to four research groups. The randomization process will be conducted using simple randomization. For this purpose, a computer-generated numerical list using Random Allocation Software will be used. This list will determine the allocation of individuals to one of the four groups (exercise, exercise + supplement, supplement, control). In this method, all individuals will have an equal chance of being placed in any of the groups, and no systematic differences in baseline characteristics will be created between the groups. Also, the data collector will not be informed of the randomization sequence to maintain at least a single-blind level, Blinding description: Data collectors, such as the nurse who conducts blood tests, do not know who was in the control, exercise, supplement, and exercise groups. 2-3 Women with metabolic syndrome. Intervention 1: The training groups will perform HIFT exercises for eight weeks, three sessions per week, each session lasting 60 to 90 minutes. HIFT exercises will be performed with a combination of resistance exercises (with body weight and free weights) and aerobic exercises in order to contribute to physical fitness factors related to health. The movements used in resistance and aerobic exercises will be functional (activities similar to daily life movements) and multi-joint. The first and last 10 minutes of each session will be dedicated to warming up and cooling down, and the main body of the exercise protocol will be accompanied by a gradual increase in intensity, duration, and repetition of exercises, according to the principle of overload. In the present study, exercise intensity control will be determined based on the rate of perceived exertion (RPE) scale. Examples of exercises that will be applied in the present study will include body weight exercises (such as burpees, Swedish push-ups, hip thrusts, various squats, lunges, crunches, etc.). Tools such as pull-ups and dumbbells will be used in the exercise sessions to increase exercise intensity (observing the principle of overload). Aerobic exercises will also be based on various aerobic movements. Subjects in the supplement group will take capsules containing black cumin extract at a dose of 500 mg twice daily (every 12 hours) with two glasses of water. Subjects in the control group will perform daily activities for 8 weeks. Intervention 2: Intervention group: Subjects in the supplement group will take capsules containing black cumin extract at a dose of 500 mg twice daily (every 12 hours) with two glasses of water. No - There is not a plan to make this available Justification or reason for not sharing IPD is No further information available.
public Zahra Esmaeili
Deh Vanak Street
Tehran Iran (Islamic Republic of) 1993891176 +98 71 4434 0448 zahraesmaeili931@gmail.com Alzahra University, Tehran scientific Zahra Esmaeili
Deh Vanak Street
Tehran Iran (Islamic Republic of) 1993891176 +98 71 4434 0448 zahraesmaeili931@gmail.com Alzahra University, Tehran Iran (Islamic Republic of) Being 35-45 years old. blood triglycerides above 150 mg/dL, HDL below 50 mg/dL, waist circumference above 88 cm fasting blood glucose above 100 mg/dL, systolic blood pressure above 130 mmHg diastolic blood pressure above 85 mmHg. 35 years 45 years Male If the subjects have cardiovascular, respiratory, nephrotic, hepatic, or neurological disorders, they will not be allowed to enter the present study. Also, if they consume alcohol or smoke, they will not be able to participate in the present study. N/A N/A The training groups will perform HIFT exercises for eight weeks, three sessions per week, each session lasting 60 to 90 minutes. HIFT exercises will be performed with a combination of resistance exercises (with body weight and free weights) and aerobic exercises in order to contribute to physical fitness factors related to health. The movements used in resistance and aerobic exercises will be functional (activities similar to daily life movements) and multi-joint. The first and last 10 minutes of each session will be dedicated to warming up and cooling down, and the main body of the exercise protocol will be accompanied by a gradual increase in intensity, duration, and repetition of exercises, according to the principle of overload. In the present study, exercise intensity control will be determined based on the rate of perceived exertion (RPE) scale. Examples of exercises that will be applied in the present study will include body weight exercises (such as burpees, Swedish push-ups, hip thrusts, various squats, lunges, crunches, etc.). Tools such as pull-ups and dumbbells will be used in the exercise sessions to increase exercise intensity (observing the principle of overload). Aerobic exercises will also be based on various aerobic movements. Subjects in the supplement group will take capsules containing black cumin extract at a dose of 500 mg twice daily (every 12 hours) with two glasses of water. Subjects in the control group will perform daily activities for 8 weeks. Intervention group: Subjects in the supplement group will take capsules containing black cumin extract at a dose of 500 mg twice daily (every 12 hours) with two glasses of water. Liver enzymes are unbalanced and elevated. Timepoint: Measurements of all desired factors will be measured two days before and two days after the 8-week intervention. Method of measurement: Liver enzymes will be measured with blood tests and special kits. Metabolic syndrome indicators are unbalanced and tend to be high. Timepoint: Measurements of all desired factors will be measured two days before and two days after the 8-week intervention. Method of measurement: Lipid profile will be measured with blood tests and special kits. Metabolic syndrome indicators are unbalanced and tend to be high. Timepoint: Measurements of all desired factors will be measured two days before and two days after the 8-week intervention. Method of measurement: central obesity index (abdominal) will be measured with a tape measure with high accuracy. Physical fitness factors (muscular endurance ) are weak. Timepoint: Measurements of all desired factors will be measured two days before and two days after the 8-week intervention. Method of measurement: muscular endurance will be measured by the number of repetitions of the sit-up and squat test. Physical fitness factors (muscular strength) are weak. Timepoint: Measurements of all desired factors will be measured two days before and two days after the 8-week intervention. Method of measurement: Muscular strength will be measured by a handgrip device. ندارم Approved 2025-10-04 Specialized Committee on Ethics in Biomedical Research, Alzahra University, Tehran Al-Zahra University, Deh Vanak Street Tehran Tehran Iran (Islamic Republic of)