Exercise ResponseNCT06704711
Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels
A study testing Caffeine 300 MG and Exercise in people with Exercise Response, run by University of Gaziantep.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 19 to 26 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Exercise Response
- What is being tested?
- Caffeine 300 MG and Exercise
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Nov 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 26 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Those who have had any previous injury, have a chronic disease, use medication, or smoke.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read more
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
- Conditions
- Exercise Response
- Being tested
- Caffeine 300 MG, Exercise, Placebo
- Keywords
- Sportomics, Salivary immunuglobulin-a, salivary lactoferrin, salivary a-amylase, caffeine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Caffeine 300 MGDietary 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.
ExerciseCombination 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.
PlaceboOther
They will rinse 20 mL of distilled water in their mouth for 20 seconds.
| Study group | Role | What they receive |
|---|---|---|
| Caffeine Mouth Rinse with incremental exercise | Experimental | 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. Receives: Dietary Supplement: Caffeine 300 MG; Combination Product: Exercise |
| Placebo Rinse with incremental exercise | Placebo comparator | 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. Receives: Combination Product: Exercise; Other: Placebo |
| Control Group | Experimental | 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. Receives: Dietary Supplement: Caffeine 300 MG |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment at 4 weeks
Secondary outcomes (1)
Rating of Perceived Exertion
It is defined as "felt strain" in terms of training.
Measured: From enrollment to the end of treatment at 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start15 Nov 2024 (estimated)
- Primary completion16 Dec 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- double-blind, randomized, placebo-controlled crossover trial design
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Gaziantep
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cemre Didem Eyipinar, University of Gaziantep
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704711
- Sponsor's protocol ID
- E-87841438-100-567059
- Status last verified
- Nov 2024
- First submitted
- 21 Nov 2024
- Last updated
- 26 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: I want to ensure that the study reaches all researchers with the link I will receive from here.
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Incremental Exercise After Caffeine Mouth Rinse on Salivary Immunoglobulin A, Lactoferrin and A-Amylase Levels
- ClinicalTrials.gov ID
- NCT06704711
- Acronym / sponsor ID
- E-87841438-100-567059
- Conditions
- Exercise Response
- Keywords
- Sportomics, Salivary immunuglobulin-a, salivary lactoferrin, salivary a-amylase, caffeine
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of GaziantepUniversity, hospital or other
- Study start
- 15 Nov 2024 (estimated)
- Primary completion
- 16 Dec 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 26 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- double-blind, randomized, placebo-controlled crossover trial design
| Arm | Type | Receives |
|---|---|---|
| Caffeine Mouth Rinse with incremental exercise | Experimental | Dietary Supplement: Caffeine 300 MG, Combination Product: ExerciseThey 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. |
| Placebo Rinse with incremental exercise | Placebo comparator | Combination Product: Exercise, Other: PlaceboThey 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. |
| Control Group | Experimental | Dietary Supplement: Caffeine 300 MGOnly rinse a solution containing a total of 400 caffeine (20 mL, 2% concentration) in the mouth for 20 seconds and receive no exercise treatment. |
Who may qualify
- Ages
- 19 to 26 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- Those who have had any previous injury, have a chronic disease, use medication, or smoke.
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Caffeine 300 MGThey 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. | Dietary supplement | Caffeine Mouth Rinse with incremental exercise, Control Group |
| ExerciseThe 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 | Caffeine Mouth Rinse with incremental exercise, Placebo Rinse with incremental exercise |
| PlaceboThey will rinse 20 mL of distilled water in their mouth for 20 seconds. | Other | Placebo Rinse with incremental exercise |
Primary outcome
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.
1 secondary outcome
Rating of Perceived Exertion
Time frame: From enrollment to the end of treatment at 4 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2024.
- Individual participant dataSharing planned: Yes. I want to ensure that the study reaches all researchers with the link I will receive from here.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Caffeine 300 MG and Exercise in people with Exercise Response, run by University of Gaziantep.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact CEMRE Cemre Didem EYPINAR (+905452645486, i1881cemre@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary antimicrobial proteins (Salivary a-amylase, lactoferrin and Ig-A) (time frame: From enrollment to the end of treatment at 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2024.