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IRCT20250403065192N1 IRCT 2025-05-09 The University of Razi Effects of acute L-theanine administration on muscle damage, physical and cognitive performance among female athletes. The Effects of Acute L-Theanine Supplementation on Muscle Damage, Physical Performance, and Cognitive Function Following a Session of Exhaustive Aerobic Activity in Female Athletes 2025-05-31 anticipated 20 Complete https://irct.ir/trial/82702 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, the block randomization method will be used through the website www.randomization.com. For this purpose, first, each subject is assigned a number as a unique identification code and a 20-digit sequence (equal to the sample size) is created. Then, the names of the intervention groups including 1) exercise + supplement group; 2) exercise + placebo group; 3) supplement group; 4) control group will be defined in the relevant section of the website. After defining the groups and in order to prevent potential problems caused by blocking with fixed-size blocks, the method of randomly selecting blocks with different sizes will be used for blocking. In this case, with the sample size being known, the block sizes will be unequal and a multiple of the number of intervention groups (for example, blocks with sizes of 2, 4, 6 or 8). The website has the ability to randomly create sequences of blocks with different sizes. In the final step, by executing the Generate Plan command on the website, all subjects are randomly assigned to blocks of different sizes that themselves have a random sequence. Finally, by using the number (code) assigned to each subject and examining the blocks, the group of each subject will be determined, Blinding description: The present study will be conducted in a single-blinded manner and participants will be kept blind to the supplement or placebo, while due to the nature of exercise training, blinding will not be done in this case (exercise intervention). In order to blind the two groups that do not receive L-theanine capsules, capsules similar to L-theanine capsules in terms of appearance, smell, taste and color will be used as placebos, and information about supplement and placebo intake will be kept secret from the subjects. N/A Muscle injury. Intervention 1: Intervention group: This group of participants will receive L-theanine supplementation. Then, the Bruce Exhaustive Aerobic Test, Balance Test, Vertical Jump Test, 20-meter Speed ​​Test, Isometric Hand Strength Test, Cognitive Function Test, Visual Analogue Scale (VAS) for Muscle Fatigue and Soreness, and the Profile of Mood States (POMS) Questionnaire will be used to evaluate the subjects. Blood sampling will also be performed in two stages, pre-test and post-test, to assess the extent of muscle damage. Intervention 2: Control group: This group of participants will receive a placebo. Then, in order to evaluate the subjects, the Bruce Exhaustive Aerobic Test, Balance Test, Vertical Jump Test, 20-meter Speed ​​Test, Isometric Hand Strength Test, Cognitive Function Test, Visual Analog Scale (VAS) for Muscle Fatigue and Soreness, and the Profile of Mood States (POMS) Questionnaire will be used. Also, in order to assess the extent of muscle damage, blood sampling will be performed in two stages, pre-test and post-test. Yes - There is a plan to make this available What will be shared: Some data can be shared after de-identifying the subjects. When: 3 months after results are published To whom: All persons upon formal request Conditions: Requests for access to data are permitted for any purpose. Where to obtain: If you need to receive documents, please send an email to Rastegar Hoseini, a member of the Razi University faculty, at the email address: rastegar.hoseini@gmail.com. How to obtain: In case of formal request, stating the relevant reasons and providing full details, the data will be sent via email after 72 hours. Comments:
public Rastegar Hoseini
Room 49, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 rastegar.hoseini@gmail.com The University of razi scientific Rastegar Hoseini
Room 49, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3845 8428 rastegar.hoseini@gmail.com The University of razi Iran (Islamic Republic of) Regularly engaged in aerobic exercise (≥4 sessions per week). No history of chronic disease or musculoskeletal injuries in the past 6 months. No supplement or medication use that may interfere with the study. Normal BMI (18.5-24.9 kg/m2). Age range 18 to 30 years 18 years 30 years Female Pregnant or breastfeeding. Allergy to L-theanine History of neurological or cognitive disorders. T06.4 Injuries of muscles and tendons involving multiple body regions Other Other Intervention group: This group of participants will receive L-theanine supplementation. Then, the Bruce Exhaustive Aerobic Test, Balance Test, Vertical Jump Test, 20-meter Speed ​​Test, Isometric Hand Strength Test, Cognitive Function Test, Visual Analogue Scale (VAS) for Muscle Fatigue and Soreness, and the Profile of Mood States (POMS) Questionnaire will be used to evaluate the subjects. Blood sampling will also be performed in two stages, pre-test and post-test, to assess the extent of muscle damage. Control group: This group of participants will receive a placebo. Then, in order to evaluate the subjects, the Bruce Exhaustive Aerobic Test, Balance Test, Vertical Jump Test, 20-meter Speed ​​Test, Isometric Hand Strength Test, Cognitive Function Test, Visual Analog Scale (VAS) for Muscle Fatigue and Soreness, and the Profile of Mood States (POMS) Questionnaire will be used. Also, in order to assess the extent of muscle damage, blood sampling will be performed in two stages, pre-test and post-test. Muscle injury assessment. Timepoint: In two stages: before taking the supplement and immediately after completing the Bruce test. Method of measurement: Through blood sampling. Balance state. Timepoint: Before and after taking the supplement or placebo. Method of measurement: Using the Tecnobody device in two static and dynamic modes. ارزیابی عملکرد شناختی. Timepoint: Before and after taking the supplement or placebo. Method of measurement: Using standard cognitive tests (Stroop test or working memory test), visual analog scale (VAS) for fatigue and muscle pain. Profile of Mood States Questionnaire (POMS). Physical performance assessment. Timepoint: Before and after taking the supplement or placebo. Method of measurement: vertical jump test to assess lower body strength, 20-meter sprint test to assess speed and anaerobic capacity, handgrip isometric strength test to assess upper body strength. The University of Razi Approved 2025-04-22 Razi University Ethics Committee Room 49, Faculty of Sport Sciences, Razi University, Daneshgah St., Taq Bostan Kermanshah Kermanshah Iran (Islamic Republic of)