Exercise Induced HyperthermiaNCT05632692
Menthol Mouth Rinsing and Performance Responses of Elite Football Referees in the Heat
A study testing Menthol solution in people with Exercise Induced Hyperthermia and Performance Demands of Exercising in the Heat, run by Universidade do Porto.
Trial summary
Ten male football referees will be recruited to perform two intermittent football protocols , separated by at least 7 days (wash-out period). After passing the eligibility criteria, the participants will be randomly assigned, according to a computer-generated allocation schedule, to 1 of 2 beverages sequences: (1)… Read more about this study
- Who is it for?
- Ages 18 to 45 years, men only
- Conditions the study is for
- Exercise Induced Hyperthermia, Performance Demands of Exercising in the Heat
- What is being tested?
- Menthol solution
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 10 Apr 2023to 1 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Male football referees aged over 18 and under 45 years;
- With normal weight (BMI ≥ 18.5 and ≤ 24.9 kg/m2);
- Availability to participate in the introductory meeting, familiarization session and 2 experimental sessions;
- Ability to read and sign the informed consent.
Who cannot join
- Under the influence of any medications that may affect urinary parameters, thermoregulation mechanisms, circulatory system, thyroid and pituitary function or metabolic status;
- Injury, diabetes, autoimmune disease, cardiovascular disease or obstructive disease of the gastrointestinal tract (e.g., diverticulitis, inflammatory bowel disease);
- Schizophrenia, bipolar disorder or other psychotic disorders;
- Eating disorders;
- MRI scans scheduled within 48 hours after familiarization session or any of the experimental trials.
About this study
Official title: Menthol Mouth Rinsing and Performance Responses of Elite Football Referees in the Heat: a Randomized Crossover Trial
Ten male football referees will be recruited to perform two intermittent football protocols , separated by at least 7 days (wash-out period). After passing the eligibility criteria, the participants will be randomly assigned, according to a computer-generated allocation schedule, to 1 of 2 beverages sequences: (1) intervention - menthol solution 0.01% (room temperature) and (2) placebo - noncaloric berry-flavoured solution (room temperature). The participants will be provided with one of the 2 beverages before warm-up (pre-cooling) and at the half-time (per-cooling). The trials will follow a randomised counterbalanced crossover design, blinded to the participants, and will take place in indoor facilities, where WBGT exceed 30◦C, at the same time of the day, to control for circadian variations. Each trial involves an exercise protocol (SAFT-90), lasting 90 minutes, separated into two 45-minute parts. The first half will be preceded by a warm-up and the second half by a 15-minute break.
The results of this study are expected to determine whether mouth rinsing a menthol solution, before a football exercise protocol performed in the heat, will help to alleviate physiological strain and improve performance parameters, comparing to a non-cooling strategy, in elite male football referees. Thus, we can be closer to defining nutritional strategies of internal cooling, that will be an advantage for the performance of the football referees, concretely in the competitions carried out under adverse environmental conditions.
- Being tested
- Menthol solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Menthol solutionOther
Menthol application, through oral solutions, stimulates the mandibular and maxillary branches of the trigeminal nerve (which are predominantly responsible for detection of temperature and nociceptive stimuli across the face and within the oral cavity) and has consistently shown to improve thermal comfort and decrease thermal sensation, which are thought to modulate perceived exertion to improve performance in the heat.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | A menthol solution is going to be formulated by crushing and dissolving one noncalorific menthol candy drop (15 mg) in 150 ml of warm water, in order to obtain a solution with a concentration of 0.01%. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each participant on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise. Receives: Other: Menthol solution |
| Placebo | Placebo comparator | A placebo beverage is going to be prepared using noncaloric berry-flavored sweetener consisting of sucralose candy drops, which will be crushed and dissolved in 150 ml of warm water. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each athlete on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise. Receives: Other: Menthol solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Heart rate change
Heart rate is a physiological parameter of performance and will be measured through HR monitors (Polar H10 Heart Rate Sensor, USA). PolarH10 can accurately measure mean HR and low-frequency oscillations (up to 0.15 Hz) of HR at rest and during exercise.
Measured: A change in heart rate from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed.
Sweating rate at the first half
Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).
Measured: Sweating rate is going to be calculated at the end of the first half of the exercise protocol (after 45 min of exercise)
Sweating rate at the second half
Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).
Measured: Sweating rate is going to be calculated at the end of the second half of the exercise protocol (after 90 min of exercise)
Core temperature change
Core temperature is a physiological parameter of performance and can be accessed using a telemetric pill ingested 30 minutes prior the start of the exercise (BodyCap®, France). Due to the good measuring accuracy, the ability to measure in field-based situations and the non-invasive character of this temperature measurement method, the ingestible telemetric temperature pill is suitable to assess core temperature during exercise
Measured: A change in core temperature from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed
Ratings of perceived exertion (RPE)
RPE is a subjective psychological/perceptual parameter that impacts performance and will be recorded through CR-10 Borg scale that goes from 0 ("rest") to 10 ("maximal effort").
Measured: RPE is going to be accessed at the end of the exercise protocol.
Thermal comfort (TC) change
TC is a subjective psychological/perceptual parameter that influences performance and is going to be accessed according to a 6-point scale from to -3 ("very uncomfortable) to 3 ("very comfortable").
Measured: A change in TC from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
Thermal sensation (TS) change
TS is a subjective psychological/perceptual parameter that impacts performance and will be recorded with a 9-point scale from -4 ("very cold") to 4 ("very warm").
Measured: A change in TS from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
Perceived thirst (PT) change
PT is a subjective marker of hydration status and will be evaluated recurring to a 7-point scale from 1 ("not thirsty at all") to 7 ("very, very thirsty")
Measured: A change in PT from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
Physical performance change
Physical performance responses will be measured using 100 Hz accelerometery, with Sonda 4.0 software (StatSports®, UK) to estimate total distance, sprint distance, accelerations and decelerations number
Measured: A change in each physical performance indicator from baseline (immediately after the warm-up) to each 15-minute block of the exercise protocol will be assessed
Secondary outcomes (8)
Hydration status before
Hydration status is going to be assessed recurring to urine test strip (Combur10 Test M, Roche) and Urisys 1100® analyser (Roche, Switzerland).
Measured: Hydration status is going to be recorder at baseline (pre-exercise)
Hydration status after
Hydration status is going to be assessed recurring to urine test strip (Combur10 Test M, Roche) and Urisys 1100® analyser (Roche, Switzerland).
Measured: Hydration status is going to be recorder at the end of the exercise protocol
Ad libitum fluid intake at the first half
Fluid intake is going to be recorded via the measurement of mass change of the individual bottles provided to the referees at the warm-up and at the end of the session, to the nearest 0.1 ml (Seca, Hamburg, Germany).
Measured: Ad libitum fluid intake is going to be assessed at the end of the first half of the exercise protocol (after 45 min of exercise)
Ad libitum fluid intake at the second half
Fluid intake is going to be recorded via the measurement of mass change of the individual bottles provided to the referees at the warm-up and at the end of the session, to the nearest 0.1 ml (Seca, Hamburg, Germany).
Measured: Ad libitum fluid intake is going to be assessed at the end of the second half of the exercise protocol (after 90 min of exercise)
Blood lactate levels before
Blood lactate levels will be measured recurring to a Blood Lactate Meter (Lactate Pro 2, Arkray, U.S.A).
Measured: Blood lactate levels are going to be recorded before the start of the exercise protocol
Blood glucose levels before
Blood glucose levels will be measured recurring to a Glucometer (FreeStyle Precision Neo, Abbott Laboratories, U.S.A).
Measured: Blood glucose levels are going to be recorded before the start of the exercise protocol
Blood glucose levels after
Blood glucose levels will be measured recurring to a Glucometer (FreeStyle Precision Neo, Abbott Laboratories, U.S.A).
Measured: Blood glucose levels are going to be recorded immediately after the end of the exercise protocol
Blood lactate levels after
Blood lactate levels will be measured recurring to a Blood Lactate Meter (Lactate Pro 2, Arkray, U.S.A).
Measured: Blood lactate levels are going to be recorded immediately after the end of the exercise protocol
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start10 Apr 2023 (estimated)
- Primary completion1 May 2023 (estimated)
- Study completion1 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Exercise Induced HyperthermiaStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade do Porto
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632692
- Sponsor's protocol ID
- 20/2021/CEFCNAUP/2021
- Status last verified
- Oct 2022
- First submitted
- 8 Nov 2022
- Last updated
- 30 Nov 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Roriz M, Brito J, Teixeira FJ, Spyrou K, Teixeira VH. The effect of menthol rinsing before intermittent exercise on physiological, physical, and thermo-behavioral responses of male football referees in hot and humid environment. Front Sports Act Living. 2024 Jan 22;6:1334739. doi: 10.3389/fspor.2024.1334739. eCollection 2024.
PubMed 38318484Roriz M, Brito J, Teixeira FJ, Spyrou K, Teixeira VH. Menthol mouth rinsing and performance in elite football referees in the heat: A study protocol for a randomized crossover trial. Contemp Clin Trials Commun. 2023 Aug 22;35:101202. doi: 10.1016/j.conctc.2023.101202. eCollection 2023 Oct.
PubMed 37691850
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Menthol Mouth Rinsing and Performance Responses of Elite Football Referees in the Heat: a Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05632692
- Acronym / sponsor ID
- 20/2021/CEFCNAUP/2021
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Universidade do PortoUniversity, hospital or other
- Study start
- 10 Apr 2023 (estimated)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 1 Jun 2023 (estimated)
- First posted
- 30 Nov 2022 (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.
Ten male football referees will be recruited to perform two intermittent football protocols , separated by at least 7 days (wash-out period). After passing the eligibility criteria, the participants will be randomly assigned, according to a computer-generated allocation schedule, to 1 of 2 beverages sequences: (1) intervention - menthol solution 0.01% (room temperature) and (2) placebo - noncaloric berry-flavoured solution (room temperature). The participants will be provided with one of the 2 beverages before warm-up (pre-cooling) and at the half-time (per-cooling). The trials will follow a randomised counterbalanced crossover design, blinded to the participants, and will take place in indoor facilities, where WBGT exceed 30◦C, at the same time of the day, to control for circadian variations. Each trial involves an exercise protocol (SAFT-90), lasting 90 minutes, separated into two 45-minute parts. The first half will be preceded by a warm-up and the second half by a 15-minute break.
The results of this study are expected to determine whether mouth rinsing a menthol solution, before a football exercise protocol performed in the heat, will help to alleviate physiological strain and improve performance parameters, comparing to a non-cooling strategy, in elite male football referees. Thus, we can be closer to defining nutritional strategies of internal cooling, that will be an advantage for the performance of the football referees, concretely in the competitions carried out under adverse environmental conditions.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Other: Menthol solutionA menthol solution is going to be formulated by crushing and dissolving one noncalorific menthol candy drop (15 mg) in 150 ml of warm water, in order to obtain a solution with a concentration of 0.01%. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each participant on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise. |
| Placebo | Placebo comparator | Other: Menthol solutionA placebo beverage is going to be prepared using noncaloric berry-flavored sweetener consisting of sucralose candy drops, which will be crushed and dissolved in 150 ml of warm water. Prior to use, solutions are going to be aliquoted for mouth rinse and warmed at room temperature. Then, it will be served to each athlete on individual bottles in a total dose of 75 ml before exercise and 75 ml during exercise. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Male football referees aged over 18 and under 45 years;
- With normal weight (BMI ≥ 18.5 and ≤ 24.9 kg/m2);
- Availability to participate in the introductory meeting, familiarization session and 2 experimental sessions;
- Ability to read and sign the informed consent.
Key exclusion criteria (5 listed)
- Under the influence of any medications that may affect urinary parameters, thermoregulation mechanisms, circulatory system, thyroid and pituitary function or metabolic status;
- Injury, diabetes, autoimmune disease, cardiovascular disease or obstructive disease of the gastrointestinal tract (e.g., diverticulitis, inflammatory bowel disease);
- Schizophrenia, bipolar disorder or other psychotic disorders;
- Eating disorders;
- MRI scans scheduled within 48 hours after familiarization session or any of the experimental trials.
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 |
|---|---|---|
| Menthol solutionMenthol application, through oral solutions, stimulates the mandibular and maxillary branches of the trigeminal nerve (which are predominantly responsible for detection of temperature and nociceptive stimuli across the face and within the oral cavity) and has consistently shown to improve thermal comfort and decrease thermal sensation, which are thought to modulate perceived exertion to improve performance in the heat. | Other | Intervention, Placebo |
Primary outcome
Heart rate change
Time frame: A change in heart rate from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed.
Heart rate is a physiological parameter of performance and will be measured through HR monitors (Polar H10 Heart Rate Sensor, USA). PolarH10 can accurately measure mean HR and low-frequency oscillations (up to 0.15 Hz) of HR at rest and during exercise.
Sweating rate at the first half
Time frame: Sweating rate is going to be calculated at the end of the first half of the exercise protocol (after 45 min of exercise)
Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).
Sweating rate at the second half
Time frame: Sweating rate is going to be calculated at the end of the second half of the exercise protocol (after 90 min of exercise)
Sweating rate is a physiological parameter of performance and is going to be calculated recurring to the following equation : SR= (Pre exercise body weight - postexercise body weight + fluid intake - urine volume)/(exercise time in hours).
Core temperature change
Time frame: A change in core temperature from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed
Core temperature is a physiological parameter of performance and can be accessed using a telemetric pill ingested 30 minutes prior the start of the exercise (BodyCap®, France). Due to the good measuring accuracy, the ability to measure in field-based situations and the non-invasive character of this temperature measurement method, the ingestible telemetric temperature pill is suitable to assess core temperature during exercise
Ratings of perceived exertion (RPE)
Time frame: RPE is going to be accessed at the end of the exercise protocol.
RPE is a subjective psychological/perceptual parameter that impacts performance and will be recorded through CR-10 Borg scale that goes from 0 ("rest") to 10 ("maximal effort").
Thermal comfort (TC) change
Time frame: A change in TC from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
TC is a subjective psychological/perceptual parameter that influences performance and is going to be accessed according to a 6-point scale from to -3 ("very uncomfortable) to 3 ("very comfortable").
Thermal sensation (TS) change
Time frame: A change in TS from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
TS is a subjective psychological/perceptual parameter that impacts performance and will be recorded with a 9-point scale from -4 ("very cold") to 4 ("very warm").
Perceived thirst (PT) change
Time frame: A change in PT from baseline (immediately before intervention) to after intervention and to each 15-minute block of the exercise protocol will be assessed.
PT is a subjective marker of hydration status and will be evaluated recurring to a 7-point scale from 1 ("not thirsty at all") to 7 ("very, very thirsty")
Physical performance change
Time frame: A change in each physical performance indicator from baseline (immediately after the warm-up) to each 15-minute block of the exercise protocol will be assessed
Physical performance responses will be measured using 100 Hz accelerometery, with Sonda 4.0 software (StatSports®, UK) to estimate total distance, sprint distance, accelerations and decelerations number
8 secondary outcomes
Hydration status before
Time frame: Hydration status is going to be recorder at baseline (pre-exercise)
Hydration status after
Time frame: Hydration status is going to be recorder at the end of the exercise protocol
Ad libitum fluid intake at the first half
Time frame: Ad libitum fluid intake is going to be assessed at the end of the first half of the exercise protocol (after 45 min of exercise)
Ad libitum fluid intake at the second half
Time frame: Ad libitum fluid intake is going to be assessed at the end of the second half of the exercise protocol (after 90 min of exercise)
Blood lactate levels before
Time frame: Blood lactate levels are going to be recorded before the start of the exercise protocol
Blood glucose levels before
Time frame: Blood glucose levels are going to be recorded before the start of the exercise protocol
Blood glucose levels after
Time frame: Blood glucose levels are going to be recorded immediately after the end of the exercise protocol
Blood lactate levels after
Time frame: Blood lactate levels are going to be recorded immediately after the end of the exercise protocol
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Derived from this study: PubMed 38318484Roriz M, Brito J, Teixeira FJ, Spyrou K, Teixeira VH. The effect of menthol rinsing before intermittent exercise on physiological, physical, and thermo-behavioral responses of male football referees in hot and humid environment. Front Sports Act Living. 2024 Jan 22;6:1334739. doi: 10.3389/fspor.2024.1334739. eCollection 2024.
- Derived from this study: PubMed 37691850Roriz M, Brito J, Teixeira FJ, Spyrou K, Teixeira VH. Menthol mouth rinsing and performance in elite football referees in the heat: A study protocol for a randomized crossover trial. Contemp Clin Trials Commun. 2023 Aug 22;35:101202. doi: 10.1016/j.conctc.2023.101202. eCollection 2023 Oct.
- Individual participant dataSharing planned: Undecided
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Menthol solution in people with Exercise Induced Hyperthermia and Performance Demands of Exercising in the Heat, run by Universidade do Porto.
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 4 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 30 Nov 2022. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Heart rate change (time frame: A change in heart rate from baseline (immediately before exercise) to each 15-minute block of the exercise protocol will be assessed.). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05632692, which also lists 2 linked publications.
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 30 Nov 2022.