Effectiveness of Topical Menthol as A Cooling Method During Exercise in A Recreational Runner Population

NCT07482046 | Completed Phase 2 DMC

• 1 other identifier: CTP.Mentol-V004/V/2023
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

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:

1. 1.Undergo a screening process including a medical history review, physical examination, resting ECG, blood sugar test, and a Bleep fitness test.
2. 2.Participate in two separate running activities at an athletic field, separated by a wash-out period of 7 days + 1 day.Have the assigned gel (menthol or placebo) applied to their neck, front upper arms, and front upper legs while running (specifically between kilometers 2.5 and 2.8).
3. 3.Complete pre-run and post-run assessments measuring weight, skin and tympanic temperature, heart rate, vertical jump height, running duration, perceived exertion (RPE), thermal sensation, and comfort.

Conditions

Heat Stress; Athletic Performance

Keywords

menthol; topical gel; mid-cooling; thermoregulation; heat stress; thermal sensation; exercise; running; athletic performance

Outcome Measures

Primary Outcomes (1)

• 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).

Secondary Outcomes (6)

• Change in Rating of Perceived Exertion (RPE)

  Immediately post-run (within 5 minutes after running completion).

• Change in Tympanic Temperature

  Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

• Running Duration

  Post-run (within 5 minutes after running completion).

• Change in Perceived Comfort

  Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

• Change in Hydration Status

  Baseline (pre-run) and immediately post-run (within 5 minutes after running completion).

Study Arms (2)

Placebo Group

PLACEBO COMPARATOR

Placebo: light blue gel where the active ingredient Menthol is replaced by purified water.

Other: Placebo

Menthol Group

EXPERIMENTAL

Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.

Drug: Light blue gel with the trademark Counterpain COOL® (License Number: POM QD. 111 709 501) containing the active substance Menthol 4%.

Interventions

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.

Menthol Group

Placebo OTHER

Light blue gel where the active ingredient Menthol is replaced by purified water.

Placebo Group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Adults, 18 - 45 years old
• Have a personal best 10-kilometer run time of under one hour (which will be confirmed during the screening of prospective Subjects through history taking) in the last 6 months.
• Doing running training at least 3 times/week for the past 1 year
• Have a level of heart-lung endurance or VO2max that is at least included in the average criteria (known through examination: Bleep test)
• Meets Subject screening criteria by answering "No" to all questions on the Physical Activity Readiness Questionnaire (PAR-Q) questionnaire.
• Have normal resting ECG and normal GDS results on screening of prospective Subjects.
• At the time of the study, the body temperature was within the normal range

You may not qualify if:

• Pregnant and/or breastfeeding women
• Have had a musculoskeletal injury in the last three months and still have symptoms or complaints
• Are experiencing acute infectious disorders, such as gastrointestinal, respiratory infections
• During treatment for chronic diseases (e.g. high blood pressure or hypertension, diabetes or diabetes mellitus, heart disease)
• Have a history of hypersensitivity or allergy to menthol or skin-applied products (especially gel-based products)
• Has a history of cold allergy
• Have a positive COVID-19 test result at the time of screening.

Sponsors & Collaborators

• Taisho Pharmaceutical Indonesia: lead
• Trisakti University: collaborator
• Atma Jaya Catholic University of Indonesia: collaborator

Study Sites (1)

Eminence Elite Clinic - Elite Club

Jakarta, DKI Jakarta, 12940, Indonesia

Location

Related Publications (21)

• 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.

  PMID: 26408395 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.

  PMID: 31902130 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.

  PMID: 21315099 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.

  PMID: 36787810 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.

  PMID: 17277604 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.

  PMID: 37161852 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.

  PMID: 37571316 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.

  PMID: 32317987 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.

  PMID: 35412444 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.

  PMID: 33358656 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.

  PMID: 36473523 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.

  PMID: 32623642 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.

  PMID: 33602709 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.

  PMID: 28349095 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.

  PMID: 27632890 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.

  PMID: 27865532 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.

  PMID: 25690408 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.

  PMID: 25380791 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.

  PMID: 17342004 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.

  PMID: 29165162 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.

  PMID: 33829868 BACKGROUND

MeSH Terms

Conditions

Heat Stress Disorders; Motor Activity

Condition Hierarchy (Ancestors)

Wounds and Injuries; Behavior

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: dr. Sp.KO., Subsp.ALK(K)

Study Record Dates

• First Submitted: March 9, 2026
• First Posted: March 19, 2026
• Study Start: May 30, 2023
• Primary Completion: October 20, 2023
• Study Completion: December 31, 2023
• Last Updated: March 19, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)