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

The Effect of Incremental Exercise After 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

Study Overview

• Status: Not yet recruiting
• Conditions: Exercise Response
• Intervention / Treatment: Dietary supplement: Caffeine 300 MG; Combination product: Exercise; Other: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: CEMRE Cemre Didem EYPINAR; Phone Number: +905452645486; Email: i1881cemre@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Dietary supplement: Caffeine 300 MG; 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.; Combination product: Exercise; 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 Comparator: 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.	Combination product: Exercise; 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.; Other: Placebo; They will rinse 20 mL of distilled water in their mouth for 20 seconds.
Experimental: 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.	Dietary supplement: Caffeine 300 MG; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Salivary antimicrobial proteins (Salivary a-amylase, lactoferrin and Ig-A)	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.	From enrollment to the end of treatment at 4 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rating of Perceived Exertion	It is defined as "felt strain" in terms of training.	From enrollment to the end of treatment at 4 weeks

Collaborators and Investigators

• Sponsor: University of Gaziantep

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2024
• Primary Completion (Estimated): December 16, 2024
• Study Completion (Estimated): December 30, 2024

Study Registration Dates

• First Submitted: November 21, 2024
• First Submitted That Met QC Criteria: November 21, 2024
• First Posted (Estimated): November 26, 2024

Study Record Updates

• Last Update Posted (Estimated): November 26, 2024
• Last Update Submitted That Met QC Criteria: November 21, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: caffeine; Sportomics; Salivary immunuglobulin-a; salivary lactoferrin; salivary a-amylase
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Neurotransmitter Agents; Purinergic Antagonists; Purinergic Agents; Central Nervous System Stimulants; Phosphodiesterase Inhibitors; Purinergic P1 Receptor Antagonists; Caffeine
• Other Study ID Numbers: E-87841438-100-567059

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: I want to ensure that the study reaches all researchers with the link I will receive from here.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes