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IRCT20230711058744N1 IRCT 2023-07-20 Razi University The effects of Ginkgo biloba on exercise and cognitive performance in hypoxic conditions after taking acetazolamide Investigating the effect of Ginkgo biloba consumption on exercise and cognitive performance in male mountaineers under hypoxia condition after taking Acetazolamide 2023-03-05 anticipated 12 Complete https://irct.ir/trial/71253 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Crossover, Purpose: Prevention, Randomization description: Someone other than researcher will use random allocation software with block randomization method to group subjects. During the grouping process, each subject will be assigned a unique identification code, which will be provided to the main researchers along with the intended intervention (ginkgo biloba or placebo). The unique identification code is used as a label to identify the group of each subject after the end of the research. The random allocation software can perform block randomization. The sample size and the names of the two groups (ginkgo biloba and placebo) are defined in the main randomization menu. Then, the block design with equal blocks is entered. Also, the formatting of the unique identification code is defined with a specific number of digits. The final step is to create a random list in which the unique identification code and group name will be specified for each number, Blinding description: Because the study was double-blind, the study subjects and researchers did not know who would take ginkgo biloba or a placebo, and someone else would check the results. Also, in order not to distinguish the drug and the placebo, they will be prepared in the same capsules and the placebo group will use maltodextrin. 3 The participants are healthy and trained male mountaineer.. Intervention 1: Ginkgo biloba group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. . Subjects take ginkgo biloba for five days and take acetazolamide on the last day (the day before the test) and take the last dose of ginkgo biloba and acetazolamide on the day of the test. In other words, they consume ginkgo biloba for a period of five days. A one-week grace period will be considered. Intervention 2: placebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. Subjects take for five days and take acetazolamide on the last day (the day before the test) and take the last dose of placebo and acetazolamide on the day of the test. In other words, they consume placebo for a period of five days. A one-week grace period will be considered. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Vahid Tadibi
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 9265 vtadibi@yahoo.com Razi University scientific Vahid Tadibi
Taq Bostan, University Blvd., Razi University, Faculty of Sports Sciences
Kermanshah Iran (Islamic Republic of) 6714414971 +98 83 3427 9265 vtadibi@yahoo.com Razi University Iran (Islamic Republic of) Active mountaineer men aged 18 to 44 years (history of climbing to altitudes higher than 4000 meters and regular climbing activity in the past one year) History of AMS in previous nights at altitudes higher than 3000 meters Body mass index between 18.5 and 24.9 Having general health to participate in sports activities approved by the doctor Regular aerobic exercise in 6 months before the beginning of the research (at least three sessions per week, including hiking) 18 years 44 years Male Suffering from any chronic disease History of cognitive disorders or neurological diseases History of allergies and sensitivities Use of any sports supplements in the two months before the start of the study Smoking and alcohol consumption Donating blood in the 2 months before the start of the study History of staying at higher altitudes From 2000 meters in two months before the beginning of the research, sleeping at an altitude above 2700 meters in two weeks before the beginning of the research Taking acetazolamide drug in two weeks before the beginning of the research Allergy to acetazolamide and sulfonamides Suffering from color blindness. Treatment - Drugs Placebo Ginkgo biloba group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. . Subjects take ginkgo biloba for five days and take acetazolamide on the last day (the day before the test) and take the last dose of ginkgo biloba and acetazolamide on the day of the test. In other words, they consume ginkgo biloba for a period of five days. A one-week grace period will be considered. placebo group: Apart from the familiarization sessions and initial measurements, the subjects attend the laboratory twice and perform the Stroop test and reaction time in normal conditions and simulated altitude conditions and the submaximal aerobic test in simulated altitude conditions. Subjects take for five days and take acetazolamide on the last day (the day before the test) and take the last dose of placebo and acetazolamide on the day of the test. In other words, they consume placebo for a period of five days. A one-week grace period will be considered. Change in the time to reach exhaustion in a submaximal endurance exercise under hypoxic conditions. Timepoint: After administration of ginkgo biloba or placebo under hypoxic conditions. Method of measurement: Record time using a stopwatch. Selective visual reaction time. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginkgo biloba or placebo and before and after applying hypoxia. Method of measurement: Cognitive performance is assessed using a reaction time device. (RESPONSE PANEL 63035A, LAFAYETTE, INDIANA). Cognitive function. Timepoint: At the beginning of the study to evaluate the level of cognitive function, after taking ginkgo biloba or placebo and before and after applying hypoxia. Method of measurement: Using the color-word Stroop test. Sense of pleasure. Timepoint: Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions. Method of measurement: Using an 11-item emotion scale. Arousal level. Timepoint: Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions. Method of measurement: Using a 6-item scale of perceived arousal. The degree of perception of pressure. Timepoint: Before and after reaching exhaustion in a submaximal endurance exercise under normobaric hypoxia conditions. Method of measurement: Using a pressure perception scale of 6 to 20 borg. Razi University Approved 2023-03-01 Ethics Committee of Razi University of Kermanshah Taq Bostan, University Street Kermanshah Kermanshah Iran (Islamic Republic of)