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IRCT20241111063676N1 IRCT 2025-03-05 Allameh tabatabaei University Effect of Plantain supplementation on oxidative stress and obesity Effect of Plantain Supplementation on exercise-induced Oxidative Stress and Muscle Damage in Overweight Adult Men: A Randomized Controlled Trial 2023-04-09 anticipated 22 Complete https://irct.ir/trial/80698 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study randomly assigned 22 overweight adult men to either the supplement(Plantago) or placebo group. To control for the potential effect of Body Mass Index(BMI) on the results, participants were first stratified based on their mean BMI and then allocated to one of two study groups using stratified randomization. Random allocation was performed using Microsoft Excel. First, participants' BMI data were entered into the software. Then, the RAND() function was used to generate a random number for each participant. Based on these random values, participants were randomly assigned to one of the two groups(11 per group) in a way that ensured a nearly equal mean BMI across both groups, Blinding description: This study was conducted in a double-blind manner, meaning that both the participants and the researchers were unaware of the intervention type (supplement or placebo) to minimize bias and ensure the reliability of the results. On the day of the test, all the executive team members, including the coach, the blood sample collector, the laboratory expert, and the statistician, were unaware of the division of the participants until the time of analyzing the results. 1-2 Overweight and Obesity. Intervention 1: Plantain extract, provided from plantain seeds, in the form of capsules. Each capsule contains 600 mg of the extract, with a daily dosage of 12 grams (2 capsules/day) half an hour after having breakfast. The Plantago extract was produced by using an industrial reactor through a step-by-step solvent extraction process involving polar solvents (water and ethanol). The extract was then transformed into a powder using a spray dryer. The resulting powdered extract was accurately weighed using a precision balance (with a sensitivity of 0.01 grams) and then capsulated in edible gelatin capsules with adherence to health protocols and standards. Finally, the capsules were sealed and packaged for use by participants. Intervention 2: For the lacebo group, 14 capsules containing 400 mg of maltodextrin were provided for 7 day. Participants were instructed to take two capsules along with a glass of water 30 minutes after brekfast each day. Aside from teh preparation of the capsules, there was no visible difference in the intervention between the study group and the placebo group. Intervention 3: Intervention Group: HIFT Training SessionThe training protocol consisted of an 8-minute warm-up, 27:30 minutes of exercise activity, and a 5-minute cool-down for all subjects in both the supplement and placebo groups.The exercise was performed as 10 functional movements in a circuit training system (two circuits, each with three sets). Each movement was performed for 30 seconds, followed by 20 seconds of active rest. After every 10 movements (1 set of exercise), subjects had a one-minute rest period. Each circuit was repeated for three sets.To standardize the activity load among participants, weights equivalent to 5% of each individual's body weight were used. Throughout the protocol, subjects were verbally encouraged to perform the movements with maximum speed and repetition.After each exercise circuit, subjects were asked about their Borg Rating of Perceived Exertion (RPE), and the score was recorded. The intensity of the exercises was performed in the range of 80-85% of maximum heart rate, which was monitored in real-time by a heart rate sensor. Yes - There is a plan to make this available What will be shared: The data will be available for publication if necessary and upon request from the corresponding author, supervisor, co-supervisor, and participants. When: within 5 years To whom: Corresponding author, supervisor, consultant, and participants Conditions: Depending on the design and request Where to obtain: Corresponding author Neda Rajamand neda.rajamand@gmail.com +989125392434 How to obtain: By sending an email and providing a clear explanation of the reason and process of the request, a response will be received within 24 hours. Comments:
public Neda Rajamand
No.29, Unit10, Sherafati St., Sheikh Bahayi Sq.
Tehran Iran (Islamic Republic of) 1995734934 +98 912 539 2434 neda.rajamand@gmail.com The University of Allame tabatabaei scientific Neda Rajamand
No.29, unit10, Sherafati St, Sheikh bahayi Sq.
Tehran Iran (Islamic Republic of) 1995734934 +98 21 8803 2774 neda.rajamand@gmail.com Allame tabatabaei University Iran (Islamic Republic of) Abdominal obesity and waist size: above 80 cm No mental disorders No history of regular physical activity in the last 6 months No hormonal treatment Non-smokers Physical ability to attend the protocol No history of surgery in the last 2 years Absence of skeletal and muscular injuries Not taking medicine and nutritional and sports supplements 35 years 50 years Male Weight loss Consumption of stimulants and energy drinks Not getting enough fluids Alcohol consumption Taking painkillers and anti-inflammatory drugs Having diabetes and high blood pressure Taking medicine Failure to complete exercise Using a diet outside of the researcher's recommendation Failure to participate in two test sessions E66 Overweight and obesity Treatment - Drugs Placebo Other Plantain extract, provided from plantain seeds, in the form of capsules. Each capsule contains 600 mg of the extract, with a daily dosage of 12 grams (2 capsules/day) half an hour after having breakfast. The Plantago extract was produced by using an industrial reactor through a step-by-step solvent extraction process involving polar solvents (water and ethanol). The extract was then transformed into a powder using a spray dryer. The resulting powdered extract was accurately weighed using a precision balance (with a sensitivity of 0.01 grams) and then capsulated in edible gelatin capsules with adherence to health protocols and standards. Finally, the capsules were sealed and packaged for use by participants. For the lacebo group, 14 capsules containing 400 mg of maltodextrin were provided for 7 day. Participants were instructed to take two capsules along with a glass of water 30 minutes after brekfast each day. Aside from teh preparation of the capsules, there was no visible difference in the intervention between the study group and the placebo group. Intervention Group: HIFT Training SessionThe training protocol consisted of an 8-minute warm-up, 27:30 minutes of exercise activity, and a 5-minute cool-down for all subjects in both the supplement and placebo groups.The exercise was performed as 10 functional movements in a circuit training system (two circuits, each with three sets). Each movement was performed for 30 seconds, followed by 20 seconds of active rest. After every 10 movements (1 set of exercise), subjects had a one-minute rest period. Each circuit was repeated for three sets.To standardize the activity load among participants, weights equivalent to 5% of each individual's body weight were used. Throughout the protocol, subjects were verbally encouraged to perform the movements with maximum speed and repetition.After each exercise circuit, subjects were asked about their Borg Rating of Perceived Exertion (RPE), and the score was recorded. The intensity of the exercises was performed in the range of 80-85% of maximum heart rate, which was monitored in real-time by a heart rate sensor. Serum levels of Superoxid dismutase. Timepoint: before the start of supplementation, seven days after supplementation, and immediately after the exercise session. Method of measurement: Superoxide dismutase serum level measuring kit made in Germany, ZellBio GmbH by ELISA method. Serum levels of malondialdehyde. Timepoint: before the start of supplementation, 7 days after supplementation, and immediately after the exercise session. Method of measurement: Malondialdehyde serum level measuring kit made in Germany, ZellBio GmbH by ELISA method. Serum levels of total antioxidantcapacity. Timepoint: before the start of supplementation, 7 days after supplementation, and immediately after the exercise session. Method of measurement: Total antioxidant capacity serum level measuring kit made in Germany, ZellBio GmbH by ELISA method. Serum levels of Lactate dehydrogenase. Timepoint: before the start of supplementation, 7 days after supplementation, and immediately after the exercise session. Method of measurement: Measurement of Lactate dehydrogenase using NAC.Kinetic UV enzyme kit by Delta Derman Part Company, Made in Iran. Serum levels of Creatine Kinase. Timepoint: before the start of supplementation, 7 days after supplementation, and immediately after the exercise session. Method of measurement: Measurement of creatine kinase using NAC.Kinetic UV enzyme kit by Delta Derman Part Company, Made in Iran. Allameh tabatabaei University Approved 2023-01-25 Ethics committee of Allameh tabatabaei University No.29,unit10, Sherafati St., Sheikh bahayi Sq. Tehran Tehran Iran (Islamic Republic of)