The Effect of Incremental Exercise After Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Salivary antimicrobial proteins (Salivary a-amylase, lactoferrin and Ig-A)
研究概览
简要总结
The goal of this clinical trial is to investigate the effects of the mouth rinse form of caffeine (400 mg) on salivary lactoferrin, α-amylase and secretory immunoglobulin-a levels after incremental exercise in young amateur football players. The main questions it aims to answer are:
- Caffeine in mouth rinse form increases salivary immunoglobulin a after incremental exercise
- Caffeine in mouth rinse form increases salivary lactoferrin after incremental exercise
- Caffeine in mouth rinse form increases salivary a-amylase after incremental exercise.
This 3-session study will use a double-blind, randomized, placebo-controlled crossover experimental design. participants will complete three different treatments [caffeine (CAF), control (C) and placebo (PLA)] separated by at least 1 week. Baseline saliva samples will be collected while sitting in a chair and then:
- CAF Group: They will rinse a solution containing a total of 400 mg caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and try to continue the exercise against increasing resistance until exhaustion.
- Control Group: Only rinse a solution containing a total of 400 caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and receive no exercise treatment.
- Placebo Group: They will rinse 20 mL of distilled water in the mouth for 20 s and try to continue the exercise against increasing resistance until exhaustion.
Saliva samples will be collected at 6 different time points: 5 minutes before exercise (or caffeine mouth rinse) (T0-reference), immediately after caffeine mouth rinse (or immediately before exercise) (T1), 5 minutes/midway through exercise (T2), and immediately after exercise (T3), 60 minutes after the end of exercise (T4) and 120 minutes after the end of exercise (T5).All data will be statistically analyzed using SPSS 25.0 software (Chicago, IL, USA) and expressed as mean ± standard deviation. Shapiro-Wilk and Levene tests will be used to determine whether the data are normally distributed and whether the variance is homogeneous. Repeated measures ANOVA test will be used to compare group means. If there is a difference between the groups as a result of the analysis, post-hoc tests will be used to find out from which group this difference originates. In cases where the data are not normally distributed, nonparametric test methods will be used. The significance level of the tests will be accepted as p<0.05
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 19 Years 至 26 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy men who have not had any previous injuries, do not have a chronic disease, do not use medication, do not smoke, and have played or are playing football as an amateur.
排除标准
- •Those who have had any previous injury, have a chronic disease, use medication, or smoke.
研究组 & 干预措施
Caffeine Mouth Rinse with incremental exercise
They will rinse a solution containing a total of 400 mg caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and try to continue the exercise against increasing resistance until exhaustion. The exercise test will be performed on a bicycle ergometer (Ergometer Exercise Bike SANA 500, Germany) (where the pedaling speed is kept constant at 60 rpm, with an initial load of 50 Watts and a load increase of 25 watts per minute, gradually increasing until the participants become exhausted. To be able to determine the degree of difficulty perceived during the test and The Borg Scale will be used to end the test when the athlete reaches the point of exhaustion.
干预措施: Exercise (Combination Product)
Placebo Rinse with incremental exercise
They will rinse 20 mL of distilled water in the mouth for 20 s and try to continue the exercise against increasing resistance until exhaustion.The exercise test will be performed on a bicycle ergometer (Ergometer Exercise Bike SANA 500, Germany) (where the pedaling speed is kept constant at 60 rpm, with an initial load of 50 Watts and a load increase of 25 watts per minute, gradually increasing until the participants become exhausted. To be able to determine the degree of difficulty perceived during the test and The Borg Scale will be used to end the test when the athlete reaches the point of exhaustion.
干预措施: Exercise (Combination Product)
Placebo Rinse with incremental exercise
They will rinse 20 mL of distilled water in the mouth for 20 s and try to continue the exercise against increasing resistance until exhaustion.The exercise test will be performed on a bicycle ergometer (Ergometer Exercise Bike SANA 500, Germany) (where the pedaling speed is kept constant at 60 rpm, with an initial load of 50 Watts and a load increase of 25 watts per minute, gradually increasing until the participants become exhausted. To be able to determine the degree of difficulty perceived during the test and The Borg Scale will be used to end the test when the athlete reaches the point of exhaustion.
干预措施: Placebo (Other)
Control Group
Only rinse a solution containing a total of 400 caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and receive no exercise treatment.
干预措施: Caffeine 300 MG (Dietary Supplement)
Caffeine Mouth Rinse with incremental exercise
They will rinse a solution containing a total of 400 mg caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and try to continue the exercise against increasing resistance until exhaustion. The exercise test will be performed on a bicycle ergometer (Ergometer Exercise Bike SANA 500, Germany) (where the pedaling speed is kept constant at 60 rpm, with an initial load of 50 Watts and a load increase of 25 watts per minute, gradually increasing until the participants become exhausted. To be able to determine the degree of difficulty perceived during the test and The Borg Scale will be used to end the test when the athlete reaches the point of exhaustion.
干预措施: Caffeine 300 MG (Dietary Supplement)
结局指标
主要结局
Salivary antimicrobial proteins (Salivary a-amylase, lactoferrin and Ig-A)
时间窗: From enrollment to the end of treatment at 4 weeks
Salivary A-Amylase: Amylase functions as an antibacterial protein that inhibits bacterial growth and colonization in the oral cavity. Salivary Lactoferrin: Lactoferrin, one of the most abundant salivary antimicrobial proteins, exerts an antibacterial effect by retaining iron, an essential nutrient for bacterial growth, and also by directly interacting with and damaging bacterial membranes. Salivary Immunuglobulin-A: Salivary IgA (SIgA) contributes to mucosal immunity by preventing pathogens from adhering to the mucosal surface.
次要结局
- Rating of Perceived Exertion(From enrollment to the end of treatment at 4 weeks)
研究者
Cemre Didem Eyipinar
Cemre Didem EYIPINAR
University of Gaziantep