The Influence of Menthol Gel During Exercise With Heat

NCT05302804 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0111-22-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available menthol gel (BioFreeze) to the skin prior to moderate intensity walking under heated conditions. Experimental Visits will consist of 30 min of treadmill walking at a moderate pace (3.5 mph, 5% grade) under hot conditions (38°C, 60%RH) and will be randomized and counterbalanced for BioFreeze or a hypoallergenic gel (control) application. Gels will be applied to areas commonly exposed during outdoor activity in warm conditions (shoulder to wrist, mid thigh to ankle). Accordingly, participants will wear shorts and a tank top shirt during exercise. Core temperature, skin temperature, galvanic skin response, laser doppler blood flow, and heart rate will be continuously recorded throughout the exercise bout via an integrated analog to digital converter. Sweat will be collected during exercise using commercially available absorbent patches. Thermal sensation will be assessed throughout exercise via the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE) thermal sensation likert scale (cold to hot). Lastly, nude body weight will be recorded pre and post exercise for sweat rate determination. The BioFreeze and control trials will be separated by a 7-14 day washout period.

Conditions

Acute Exercise; Heat Exposure

Keywords

heat exposure; menthol; exercise

Outcome Measures

Primary Outcomes (9)

• Skin Blood Flow

  Laser Doppler measurement of skin blood flow

  10 minutes into exercise bout

• Skin Blood Flow

  Laser Doppler measurement of skin blood flow

  30 minutes into exercise bout

• Galvanic Skin Response

  measurement of skin conductance

  Time to 40 micro-siemens

• Sweat Composition

  Sodium concentrations in collected sweat

  final 10 minutes of exercise bout

• Sweat Rate

  Difference in Nude body weight from pre to post exercise is assumed to be the amount of weight lost via sweat. This value is then expressed as liters of sweat lost per hour if the intervention was to last 1 hr.

  pre to post exercise, approximately 30 minutes

• Thermal Perception

  scale of thermal comfort developed by the American Society of Heating, Refrigerating and Air-Conditioning Engineers (ASHRAE). The ASHRAE is a 7-point scale to asses thermal sensation, which consists of seven verbal anchors: "cold (-3)", "cool (-2)", "slightly cool (-1)", "neutral (0)", "slightly warm (1)", "warm (2)", and "hot (3)". The score is reported as the value in "()"

  throughout the 30 minute exercise bout

• Average Skin Temperature

  average measurements from chest, forearm, and calf thermistors

  after 30 minutes of exercise

• Core Temperature

  measured with rectal thermistor

  after 30min exercise

• Sweat Potassium Concentration

  this is a measure of the amount of potassium in the sweat

  final 10 minutes of the exercise bout

Secondary Outcomes (2)

• % Body Fat

  preliminary testing before beginning the study

• Skin Surface Area

  preliminary testing completed prior to the study procedures

Study Arms (2)

Menthol Gel first, then hypoallergenic gel

EXPERIMENTAL

Participants randomized to receive menthol gel first then hypoallergenic gel after 7 day washout. Gel is applied to the skin (arm and thigh). Participants walk on a treadmill for 30 minutes (3.5 mph at 5% grade) in 38°C and 60% relative humidity.

Drug: Menthol Gel; Drug: Control Gel

Hypoallergenic Gel first, then menthol

EXPERIMENTAL

Participants randomized to receive hypoallergenic gel first then menthol gel after 7 day washout. Gel is applied to the skin (arm and thigh). Participants walk on a treadmill for 30 minutes (3.5 mph at 5% grade) in 38°C and 60% relative humidity.

Drug: Menthol Gel; Drug: Control Gel

Interventions

Menthol Gel DRUG

5% menthol gel applied from shoulder to wrist and mid thigh to ankle, 30 minute treadmill walk (3.5 mph at 5% grade at 38°C, 60% relative humidity)

Also known as: BioFreeze

Hypoallergenic Gel first, then menthol; Menthol Gel first, then hypoallergenic gel

Control Gel DRUG

Hypoallergenic gel applied from shoulder to wrist and mid thigh to ankle, 30 minute treadmill walk (3.5 mph at 5% grade at 38°C, 60% relative humidity)

Also known as: placebo

Hypoallergenic Gel first, then menthol; Menthol Gel first, then hypoallergenic gel

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• years of age
• cleared for physical activity via the 2022 physical activity readiness questionnaire (PARQ)
• no self-reported adverse reactions to menthol based gels

You may not qualify if:

• outside 19-45 years of age
• not cleared for physical activity via the 2022 physical activity readiness questionnaire (PARQ)
• self-report or signs of sensitivity to menthol gels
• pregnant
• breast feeding

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Dustin Slivka
• Organization: University of Montana

dustin.slivka@umontana.edu

(406) 243-2389

Study Officials

• Dustin R Slivka, PhD

  University of Montana

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Each Subject acts as their own control in a repeated measures design

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 31, 2022
• Study Start: May 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: April 24, 2024
• Results First Posted: April 24, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)