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IRCT20260809070591N1 IRCT 2026-10-29 Alzahra University The effect of caffeine supplementation on corticomuscular coherence ECSCC The effect of caffeine supplementation on corticomuscular coherence at specific levels of perceived exertion during cycling to exhaustion in active women 2026-11-06 anticipated 15 Recruiting https://irct.ir/trial/92593 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Other, Randomization description: Given the randomized crossover design of the study, participants were randomly assigned to one of two treatment sequences, AB or BA. For this purpose, seven X codes and eight Y codes were prepared, mixed thoroughly, and randomly assigned to the participants by an individual who was independent of the intervention procedures and outcome assessment. The correspondence between the X and Y codes and the treatment sequences was maintained by an independent individual and remained concealed until completion of data collection. In the AB sequence, participants received caffeine in the second session and placebo in the third session, whereas in the BA sequence, placebo was administered in the second session and caffeine in the third session. Thus, the treatment sequence was randomly allocated, and both the participants and outcome assessor were blinded to the intervention received in each session, Blinding description: The participants in the study and the outcome assessor are kept blinded to the study groups and have no information regarding the type of capsule consumed (caffeine or placebo) by the participants. N/A Corticomuscular coherence. Intervention 1: Intervention Group 1:Participants assigned to this sequence attended a familiarization session (Session 1), during which they became familiar with the testing procedures and equipment and received no intervention. In Session 2, they received a caffeine capsule, and in Session 3, they received a placebo capsule. Caffeine was administered in the form of a capsule containing pure caffeine powder at a dose of 6 mg/kg body weight. The placebo consisted of a capsule containing wheat bran powder. The caffeine and placebo capsules were identical in appearance, size, and taste. Each capsule was consumed with one glass of water 60 minutes before the cycling exercise test. A one-week washout period was maintained between Sessions 2 and 3. Each study session lasted approximately 90–120 minutes. The caffeine powder used in the study was obtained from Pooyan Nutrition Co. Intervention 2: Intervention Group 2: In this sequence, participants first attended Session 1 as a familiarization session, during which they were introduced to the study protocol, testing procedures, and equipment used. No supplement was administered during this session. In Session 2, participants received the placebo, followed by a one-week washout period, after which caffeine was administered in Session 3. The placebo consisted of capsules containing wheat bran powder, whereas caffeine was provided in capsules containing pure caffeine powder at a dose of 6 mg/kg body weight. Both types of capsules were identical in appearance, size, and taste and were indistinguishable from each other. The capsules were consumed with one glass of water 60 minutes before the cycling exercise test. Each study session lasted approximately 90–120 minutes. The caffeine powder used in this study was obtained from Pooyan Nutrition Co. 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 There is no further information
public Leila Ghazale
Alzahra University, Deh Vanak Street, Tehran Town
Tehran Iran (Islamic Republic of) ۱۹۹۳۸۹۳۹۷۳ +98 21 8804 4040 lighazale@gmail.com The University of Alzahra scientific Leila Ghazale
Alzahra University, Deh Vanak Street, Tehran Town
Tehran Iran (Islamic Republic of) ۱۹۹۳۸۹۳۹۷۳ +98 21 8804 4040 lighazale@gmail.com The University of Alzahra Iran (Islamic Republic of) Here is the translation:- Possessing physical health, absence of musculoskeletal abnormalities, absence of neuromuscular and cardiopulmonary diseases, and absence of mental disorders. Being physically active (engaging in regular exercise that includes an average of 150 to 300 minutes of moderate-intensity aerobic activity and muscle-strengthening exercises, or 75 to 150 minutes of high-intensity activity per week, such that all major muscle groups of the body are involved). Having a normal weight according to body mass index (BMI of 18–23 kg/m²). Not using tobacco, alcohol, drugs affecting the central nervous system (such as anti-anxiety medications), or sports supplements. Consuming caffeine at a moderate and usual level (a maximum of 70 mg per day) (47) – which was assessed via a standard caffeine consumption questionnaire. Having a regular menstrual pattern with cycles of 26 to 32 days, in order to control for hormonal effects on physiological variables. 18 years 35 years Female Developing an acute illness or physical injury that makes continued participation in the study impossible or unsafe Lack of willingness to cooperate on the part of the participant Z00.6 Encounter for examination for normal comparison and control in clinical research program N/A N/A Intervention Group 1:Participants assigned to this sequence attended a familiarization session (Session 1), during which they became familiar with the testing procedures and equipment and received no intervention. In Session 2, they received a caffeine capsule, and in Session 3, they received a placebo capsule. Caffeine was administered in the form of a capsule containing pure caffeine powder at a dose of 6 mg/kg body weight. The placebo consisted of a capsule containing wheat bran powder. The caffeine and placebo capsules were identical in appearance, size, and taste. Each capsule was consumed with one glass of water 60 minutes before the cycling exercise test. A one-week washout period was maintained between Sessions 2 and 3. Each study session lasted approximately 90–120 minutes. The caffeine powder used in the study was obtained from Pooyan Nutrition Co. Intervention Group 2: In this sequence, participants first attended Session 1 as a familiarization session, during which they were introduced to the study protocol, testing procedures, and equipment used. No supplement was administered during this session. In Session 2, participants received the placebo, followed by a one-week washout period, after which caffeine was administered in Session 3. The placebo consisted of capsules containing wheat bran powder, whereas caffeine was provided in capsules containing pure caffeine powder at a dose of 6 mg/kg body weight. Both types of capsules were identical in appearance, size, and taste and were indistinguishable from each other. The capsules were consumed with one glass of water 60 minutes before the cycling exercise test. Each study session lasted approximately 90–120 minutes. The caffeine powder used in this study was obtained from Pooyan Nutrition Co. Time to exhaustion (in seconds or minutes) during cycling at a constant workload. Timepoint: The test begins 60 minutes after caffeine or placebo consumption. Time to exhaustion is measured in seconds, from the start of the fatigue protocol until the moment of test termination (RPE = 10 or reaching maximum heart rate). Method of measurement: by cronometer. Corticomuscular coherence in the rectus femoris muscle at specified RPE scales. Timepoint: 60 minutes after caffeine or placebo ingestion. Method of measurement: Using EEG and EMG devices, with simultaneous synchronization of both signals. Corticomuscular coherence in the gastrocnemius muscle at specified RPE scales. Timepoint: 60 minutes after caffeine or placebo ingestion. Method of measurement: Using EEG and EMG devices, with simultaneous synchronization of both signals. Corticomuscular coherence in the vastus medialis muscle at specified RPE scales. Timepoint: 60 minutes after caffeine or placebo ingestion. Method of measurement: Using EEG and EMG devices, with simultaneous synchronization of both signals. Corticomuscular coherence in the biceps femoris muscle at specified RPE scales. Timepoint: 60 minutes after caffeine or placebo ingestion. Method of measurement: Using EEG and EMG devices, with simultaneous synchronization of both signals. Alzahra University Approved 2025-11-05 Ethics committee of Alzahra University Alzahra University, Deh Vanak Street, Tehran Town Tehran Tehran Iran (Islamic Republic of)