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NCT Number: NCT06704711

Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels

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

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Key information

Conditions

Exercise Response

Age range

19 year–26 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

Those who have had any previous injury, have a chronic disease, use medication, or smoke.

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Treatment and study plan

Caffeine 300 MG

Dietary Supplement

They will rinse the solution containing a total of 400 mg of caffeine (20 mL, 2% density) in the mouth for 20 seconds and try to continue the exercise against increasing resistance until exhaustion.

Exercise

Combination Product

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.

Placebo

Other

They will rinse 20 mL of distilled water in their mouth for 20 seconds.

Primary outcomes

  1. Salivary antimicrobial proteins (Salivary a-amylase, lactoferrin and Ig-A)

    Time frame: 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.

Secondary outcomes

  1. Rating of Perceived Exertion

    Time frame: From enrollment to the end of treatment at 4 weeks

    It is defined as "felt strain" in terms of training.

Study contacts

Contact information is provided by the study sponsor or research team.

CEMRE Cemre Didem EYPINAR

CONTACT

[email protected]

+905452645486

Sponsors and collaborators

Lead sponsor

University of Gaziantep

Other

Registry information

Official study title

The Effect of Incremental Exercise After Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Nov 26, 2024
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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