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| Name | Class |
|---|---|
| Trisakti University | OTHER |
| Atma Jaya Catholic University of Indonesia | OTHER |
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The goal of this clinical trial is to evaluate the effectiveness of topical menthol as a cooling method during exercise in a hot air environment in healthy adult recreational runners aged 18 to 45 years.
The main questions it aims to answer are:
What is the difference in thermal sensation between the topical menthol gel application and a placebo during exercise? How does the application of topical menthol affect body temperature, heart rate, and physical performance compared to a placebo? Researchers will compare a 4% Menthol gel to a placebo gel in a cross-over design to see if the menthol gel improves thermal sensation, regulates body temperature, and enhances physical performance and comfort.
Participants will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Group | Placebo Comparator | Placebo: light blue gel where the active ingredient Menthol is replaced by purified water. |
|
| Menthol Group | Experimental | Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%. | Drug | The test drug, i.e. 4% Menthol gel or placebo, will be applied by rubbing on the neck area, the front side of the upper arm and the front side of the upper leg. The neck area was chosen because there is a carotid artery in the neck area, which is said to have an impact on changes in body temperature in the hypothalamus. In addition, the upper arm and upper leg areas were chosen because they are the extremity areas closest to the core of the body and perform a lot of movement while running. Some journals concluded that the application of cooling methods in the hand and thigh area is effective for cooling methods. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Thermal Sensation | Assessed using a 7-point thermal sensation scale. The scale ranges from -3 to +3, where -3 represents "cold", 0 represents "neutral", and +3 represents "hot". A higher score indicates a greater sensation of heat. | Baseline (pre-run), during run (~20 minutes), and immediately post-run (within 5 minutes after running completion). |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Rating of Perceived Exertion (RPE) | Assessed using the Borg Rating of Perceived Exertion (RPE) scale. The scale ranges from 6 to 20, where 6 indicates "no exertion at all" and 20 indicates "maximal exertion". Higher scores represent a greater perceived physical effort by the participant. | Immediately post-run (within 5 minutes after running completion). |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eminence Elite Clinic - Elite Club | Jakarta | DKI Jakarta | 12940 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26408395 | Background | Stevens CJ, Thoseby B, Sculley DV, Callister R, Taylor L, Dascombe BJ. Running performance and thermal sensation in the heat are improved with menthol mouth rinse but not ice slurry ingestion. Scand J Med Sci Sports. 2016 Oct;26(10):1209-16. doi: 10.1111/sms.12555. Epub 2015 Sep 26. | |
| 31902130 | Background | Hermand E, Collado A, Hue O. Skin Application of 4% Menthol Enhances Running Performance in Hot and Humid Climate. Int J Sports Med. 2020 Mar;41(3):161-167. doi: 10.1055/a-1062-6520. Epub 2020 Jan 5. |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | May 19, 2023 |
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|
| Placebo | Other | Light blue gel where the active ingredient Menthol is replaced by purified water. |
|
| Change in Tympanic Temperature | Measured in degrees Celsius (°C) using a tympanic thermometer to evaluate thermoregulation and core body temperature changes in response to the running exercise and cooling intervention | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). |
| Running Duration | Running duration was calculated as the time the subject took to complete a 5-kilometer run (in minutes) using a digital pocket sports stopwatch | Post-run (within 5 minutes after running completion). |
| Change in Perceived Comfort | To evaluate perceived comfort, participants used a scale that included the options: "comfortable," "somewhat uncomfortable," "uncomfortable," and "extremely uncomfortable | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). |
| Change in Hydration Status | Hydration status, categorized as "well-hydrated," "mildly dehydrated," or "dehydrated,". Pre run hydration status was assessed by matching urine color to a color chart. Post run hydration status was assessed through percentage body weight (BW) loss | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). |
| Change in Heart Rate | Measured in beats per minute (bpm) was measured using a Polar Heart Rate Monitor to evaluate cardiovascular strain and physical intensity during the running exercise. This will include assessing the mean heart rate and the highest heart rate frequency. | Baseline (pre-run) and immediately post-run (within 5 minutes after running completion). |
| 21315099 | Background | Schlader ZJ, Simmons SE, Stannard SR, Mundel T. The independent roles of temperature and thermal perception in the control of human thermoregulatory behavior. Physiol Behav. 2011 May 3;103(2):217-24. doi: 10.1016/j.physbeh.2011.02.002. Epub 2011 Feb 16. |
| 36787810 | Background | Greenfield AM, Alba BK, Giersch GEW, Seeley AD. Sex differences in thermal sensitivity and perception: Implications for behavioral and autonomic thermoregulation. Physiol Behav. 2023 May 1;263:114126. doi: 10.1016/j.physbeh.2023.114126. Epub 2023 Feb 12. |
| 17277604 | Background | American College of Sports Medicine; Sawka MN, Burke LM, Eichner ER, Maughan RJ, Montain SJ, Stachenfeld NS. American College of Sports Medicine position stand. Exercise and fluid replacement. Med Sci Sports Exerc. 2007 Feb;39(2):377-90. doi: 10.1249/mss.0b013e31802ca597. |
| 37161852 | Background | Peel J, John K, Page J, Jeffries O, Heffernan SM, Tallent J, Waldron M. Topical application of isolated menthol and combined menthol-capsaicin creams: Exercise tolerance, thermal perception, pain, attentional focus and thermoregulation in the heat. Eur J Sport Sci. 2023 Oct;23(10):2038-2048. doi: 10.1080/17461391.2023.2211966. Epub 2023 Jun 2. |
| 37571316 | Background | Vogel RM, Varone N, Clark C, Ramirez K, Ross MLR, Swann C, Stevens CJ. A Menthol-Enhanced "Cooling" Energy Gel Does Not Influence Laboratory Time Trial Performance in Trained Runners. Nutrients. 2023 Jul 29;15(15):3379. doi: 10.3390/nu15153379. |
| 32317987 | Background | Silva H. Current Knowledge on the Vascular Effects of Menthol. Front Physiol. 2020 Apr 7;11:298. doi: 10.3389/fphys.2020.00298. eCollection 2020. |
| 35412444 | Background | de Camargo R, Vilaca A, Mota GR, Elsangedy HM, Haile L, Sasaki JE. The Influence of L-menthol on Time Trial Running Performance in Recreational Runners. Res Q Exerc Sport. 2023 Jun;94(2):510-518. doi: 10.1080/02701367.2021.2014049. Epub 2022 Apr 12. |
| 33358656 | Background | Kenney WL, Wolf ST, Dillon GA, Berry CW, Alexander LM. Temperature regulation during exercise in the heat: Insights for the aging athlete. J Sci Med Sport. 2021 Aug;24(8):739-746. doi: 10.1016/j.jsams.2020.12.007. Epub 2020 Dec 25. |
| 36473523 | Background | Yoshimura S, Nakamura S, Morimoto T. Changes in neural activity during the combining affect labeling and reappraisal. Neurosci Res. 2023 May;190:51-59. doi: 10.1016/j.neures.2022.12.001. Epub 2022 Dec 5. |
| 32623642 | Background | Barwood MJ, Gibson OR, Gillis DJ, Jeffries O, Morris NB, Pearce J, Ross ML, Stevens C, Rinaldi K, Kounalakis SN, Riera F, Mundel T, Waldron M, Best R. Menthol as an Ergogenic Aid for the Tokyo 2021 Olympic Games: An Expert-Led Consensus Statement Using the Modified Delphi Method. Sports Med. 2020 Oct;50(10):1709-1727. doi: 10.1007/s40279-020-01313-9. |
| 33602709 | Background | AlOmar RS, AlShamlan NA, AlAmer NA, Aldulijan F, AlMuhaidib S, Almukhadhib O, Algarni SA, Alshaibani A, Darwish M, Al Shammari M. What are the barriers and facilitators of volunteering among healthcare students during the COVID-19 pandemic? A Saudi-based cross-sectional study. BMJ Open. 2021 Feb 18;11(2):e042910. doi: 10.1136/bmjopen-2020-042910. |
| 28349095 | Background | Bongers CC, Hopman MT, Eijsvogels TM. Cooling interventions for athletes: An overview of effectiveness, physiological mechanisms, and practical considerations. Temperature (Austin). 2017 Jan 3;4(1):60-78. doi: 10.1080/23328940.2016.1277003. eCollection 2017. |
| 27632890 | Background | Adams WM, Hosokawa Y, Casa DJ. Body-Cooling Paradigm in Sport: Maximizing Safety and Performance During Competition. J Sport Rehabil. 2016 Dec;25(4):382-394. doi: 10.1123/jsr.2015-0008. Epub 2016 Aug 24. |
| 27865532 | Background | Hosokawa Y, Adams WM, Belval LN, Vandermark LW, Casa DJ. Tarp-Assisted Cooling as a Method of Whole-Body Cooling in Hyperthermic Individuals. Ann Emerg Med. 2017 Mar;69(3):347-352. doi: 10.1016/j.annemergmed.2016.08.428. Epub 2016 Nov 16. |
| 25690408 | Background | Nassis GP, Brito J, Dvorak J, Chalabi H, Racinais S. The association of environmental heat stress with performance: analysis of the 2014 FIFA World Cup Brazil. Br J Sports Med. 2015 May;49(9):609-13. doi: 10.1136/bjsports-2014-094449. Epub 2015 Feb 17. |
| 25380791 | Background | Guy JH, Deakin GB, Edwards AM, Miller CM, Pyne DB. Adaptation to hot environmental conditions: an exploration of the performance basis, procedures and future directions to optimise opportunities for elite athletes. Sports Med. 2015 Mar;45(3):303-11. doi: 10.1007/s40279-014-0277-4. |
| 17342004 | Background | Mardikar HM, Mukherjee D. Current endovascular treatment of peripheral arterial disease. Prog Cardiovasc Nurs. 2007 Winter;22(1):31-7. doi: 10.1111/j.0889-7204.2007.05596.x. |
| 29165162 | Background | Kakamu T, Wada K, Smith DR, Endo S, Fukushima T. Preventing heat illness in the anticipated hot climate of the Tokyo 2020 Summer Olympic Games. Environ Health Prev Med. 2017 Sep 19;22(1):68. doi: 10.1186/s12199-017-0675-y. |
| 33829868 | Background | Periard JD, Eijsvogels TMH, Daanen HAM. Exercise under heat stress: thermoregulation, hydration, performance implications, and mitigation strategies. Physiol Rev. 2021 Oct 1;101(4):1873-1979. doi: 10.1152/physrev.00038.2020. Epub 2021 Apr 8. |
| Mar 8, 2026 |
| Prot_SAP_ICF_000.pdf |
| ID | Term |
|---|---|
| D018882 | Heat Stress Disorders |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D014947 | Wounds and Injuries |
| D001519 | Behavior |
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