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IRCT20240328061378N1 IRCT 2024-12-08 Allameh Tabataba'i University A Soccer Match Increases Antioxidant Irrespective of Lemon Balm Supplementation The effect of lemon balm on oxidative stress and antioxidant response in amateur adolescent football players 2024-02-19 anticipated 20 Complete https://irct.ir/trial/79859 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Prevention, Randomization description: The study will use a simple randomization method. Participants are randomly assigned into two groups—an intervention group receiving lemon balm and a placebo group. The randomization will be done at the individual level, with each of the 20 soccer players assigned to one of the two groups. A computer-generated sequence will be used to allocate participants to each group randomly. This method provides high precision and reproducibility, minimizing selection bias. The sequence will be generated in a computer system to ensure unpredictability. Allocation concealment will be achieved by keeping this sequence hidden from the researchers and participants until after the intervention is completed, Blinding description: The study is double-blind, meaning that neither the participants nor the researchers (including principal investigators and outcome assessors) will know who will receive the intervention or the placebo. This will be accomplished by using identical capsules for the lemon balm and placebo, thus preventing visual differentiation. The adolescent soccer players will not know whether they are receiving the supplement or placebo. Those responsible for collecting and analyzing the blood samples and performance data will be blinded to group assignments, ensuring unbiased results and principal Investigators will Remain blinded to group allocations during data collection and analysis. 0 (exploratory trials) Healthy Adolescent. Intervention 1: Control group: in this group we have not any intervention during the protocol and will consider this group as placebo. Intervention 2: Intervention group: This group will receive 1.5 g/day of dried extract of lemon balm. Yes - There is a plan to make this available What will be shared: The report will be submitted to the university's research department. Also published as a paper When: 2025 To whom: All researchers Conditions: Citing references Where to obtain: Scientific bases and Allameh Tabatabai University of Iran How to obtain: Maximum a week Comments:
public Ali Nejatian Hoseinpour
Chamran St, Kabiri Tamme, Jantabad Central
Tehran Iran (Islamic Republic of) 1111111111 0098513233354 alinejatiyan70@gmail.com Allameh Tabataba'i University scientific Ali Nejatian Hoseinpour
Chamran St, Kabiri Tamme, Jantabad Central
Tehran Iran (Islamic Republic of) 1111111111 0098513233354 alinejatiyan70@gmail.com Allameh Tabataba'i University Iran (Islamic Republic of) Soccer players who have to have at least one year of experience playing soccer in provincial or national competitions and trained at least six hours per week. 10 years 19 years Male They will be excluded if they have had any injuries, illnesses, or infectious diseases or if they have consumed steroidal or non-steroidal anti-inflammatory drugs or nutritional supplements such as vitamins E and C in the last six months. Placebo Treatment - Other Control group: in this group we have not any intervention during the protocol and will consider this group as placebo Intervention group: This group will receive 1.5 g/day of dried extract of lemon balm Total Antioxidant Capacity. Timepoint: Before and after the supplementation, 30 and 90 minutes after the match. Method of measurement: Biochemical and laboratory methods. Superoxide dismutase. Timepoint: Before and after the supplementation, 30 and 90 minutes after the match. Method of measurement: Biochemical and laboratory methods. Glutathione peroxidase. Timepoint: Before and after the supplementation, 30 and 90 minutes after the match. Method of measurement: Biochemical and laboratory methods. Catalase. Timepoint: Before and after the supplementation, 30 and 90 minutes after the match. Method of measurement: Biochemical and laboratory methods. Malondialdehyde. Timepoint: Before and after the supplementation, 30 and 90 minutes after the match. Method of measurement: Biochemical and laboratory methods. دانشگاه علامه طباطبایی Approved 2023-04-08 Research Ethics Committees of Allameh Tabataba'i University (ATU) Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)