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Acute ExercisePhase 4NCT05302804

The Influence of Menthol Gel During Exercise With Heat

A Phase 4 study testing Menthol Gel in people with Acute Exercise and Heat Exposure, run by University of Nebraska at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 19 to 45 yearsHealthy volunteers can take part
Conditions the study is for
Acute Exercise, Heat Exposure
What is being tested?
Menthol Gel
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteUnited States
Study dates
1 May 2022to 1 Oct 2022
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 45 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 19-45 years of age
  • cleared for physical activity via the 2022 physical activity readiness questionnaire (PARQ)
  • no self-reported adverse reactions to menthol based gels

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Nebraska at Omaha

    Omaha, Nebraska, 68182

Other trials in United States

About this study

Official title: The Influence of Topical Menthol Gel on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat

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.

Read the detailed description

3 experimental visits to the laboratory will be conducted. All visits will take place at the University of Nebraska at Omaha, Exercise Physiology Laboratory. Visit 1 will consist of the physical activity readiness questionnaire (PARQ), adverse reaction to BioFreeze, and body composition (hydrostatic weigh, bioelectrical impedance). Visits 2 and 3 will be separated by 7-14 days, randomized, and counterbalanced for experimental (BioFreeze) and control (hypoallergenic cream) trials. Both the experimental and control visits will follow the same protocol.

Participants will arrive following an overnight fast state while also refraining from strenuous activity, alcohol consumption, tobacco use, and recreational drugs for the previous 24 hour period. During these visit researchers will apply BioFreeze using a gloved hand from shoulder to wrist and mid thigh to ankle (areas outside of the clothing). A hypoallergenic cream will be applied during the control visit.

Exercise will consist of 30 min of moderate intensity treadmill walking (3.5 mph at 5% grade) within a heated temperature/humidity controlled chamber (38°C, 60% relative humidity). Participants will be weighed before, and after completion of the exercise calculate sweat rate. Prior to the exercise session, participants will sit for 5 min in an ambient room temperature environment as a baseline. During baseline and during the exercise core temperature, skin temperature, laser doppler blood flow, galvanic skin response, and heart rate will be collected continuously. Sweat patches will be adhered to the forehead during exercise at minute 10 for collection of sweat composition over the next 10-20 minutes. Thermal perception using the ASHRAE scale (cold to hot) will be assessed pre and during exercise.

VISIT 1 Visit 1 will take approximately 1 hour. Informed consent will be given. Participants will then complete the physical activity readiness questionnaire (PARQ) to be cleared for physical activity. Participants will have a small amount of the BioFreeze cream applied to a small area of the forearm (~2 x 2 in) to test for any adverse reaction over a period of 15 minutes. This initial skin reaction test is not a part of the research protocol. Those without a reaction will have height, weight, and body fat composition measured. Height and weight will be measured using a medical scale and stadiometer, respectively. Body fat will be assessed with hydrostatic weighing using an electronic load cell based system (Exertech, Dresbach, MN) correcting for residual lung volume or via a bio-electrical impedance analyzer (InBodyUSA, Cerritos, CA).

VISITS 2 AND 3 Visits 2 and 3 will take approximately 2 hours each. Upon arrival at the lab, a nude body weight will be collected with the subject in a private room. While still in the room, subjects will self-insert a rectal thermistor 12-15 cm beyond the anal sphincter and don a chest strap heart rate monitor. After dressing in their exercise clothing, subjects will exit the private room so that chest, forearm, and calf thermistors can be adhered to the skin with tape. Laser doppler flow (forearm and or/finger) will be adhered with tape and galvanic skin response (fingers) will be adhered using Velcro straps to the skin. Measuring instruments will be recorded using an integrated digital to analog converter (ADInstruments, Colorado Springs, CO).

Following instrumentation, subjects will sit for 5 minutes as a baseline in a temperate environment. Immediately after, a researcher with gloved hands will topically apply BioFreeze or the control hypoallergenic cream from the shoulder to wrist and mid-thigh to ankle. Subjects will then enter the heat chamber (38°C, 60% relative humidity) and immediately begin a 30-minute walk on a treadmill (3.5 mph, 5% grade). Subjects will be intermittently asked to hold their arm steady for laser doppler flow collection (10, 20, 30 minutes). Subjects will also briefly pause at minute 10 in order to adhere an absorbent patch to their forehead for sweat collection over the following 10-20 minutes. Thermal perception using the ASHRAE scale (cold to hot) will be assessed pre and during exercise. After 30 minutes of walking, subjects will exit the chamber for removal of all skin and finger sensors. Subjects will then re-enter the private room, remove their own rectal thermistor with gloved hands, and then a final nude body weight will be recorded after toweling off.

The rectal thermistor will measure core temperature. The heart rate monitor will measure the beats of the heart. Skin thermistors will measure the temperature of the skin surfaces. Laser doppler flow measure the relative units of blood flow velocity. Galvanic skin response measures skin conductivity changes as individuals begin to sweat. Sweat is collected for assessment of sweat composition. Thermal perception is assessed for individual perception surrounding the temperature of the ambient environment. Nude body weight is measured to calculate sweat rate.

Being tested
Menthol Gel, Control Gel
Keywords
heat exposure, menthol, exercise
Medical subject headings
Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Menthol GelDrug

    Also called BioFreeze

    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)

  • Control GelDrug

    Also called placebo

    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)

Study groups in NCT05302804
Study groupRoleWhat they receive
Menthol Gel first, then hypoallergenic gelExperimentalParticipants 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.
Receives: Drug: Menthol Gel; Drug: Control Gel
Hypoallergenic Gel first, then mentholExperimentalParticipants 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.
Receives: Drug: Menthol Gel; Drug: Control Gel

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Skin Blood Flow

    Laser Doppler measurement of skin blood flow

    Measured: 10 minutes into exercise bout

  2. Skin Blood Flow

    Laser Doppler measurement of skin blood flow

    Measured: 30 minutes into exercise bout

  3. Galvanic Skin Response

    measurement of skin conductance

    Measured: Time to 40 micro-siemens

  4. Sweat Composition

    Sodium concentrations in collected sweat

    Measured: final 10 minutes of exercise bout

  5. 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.

    Measured: pre to post exercise, approximately 30 minutes

  6. 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 "()"

    Measured: throughout the 30 minute exercise bout

  7. Average Skin Temperature

    average measurements from chest, forearm, and calf thermistors

    Measured: after 30 minutes of exercise

  8. Core Temperature

    measured with rectal thermistor

    Measured: after 30min exercise

  9. Sweat Potassium Concentration

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

    Measured: final 10 minutes of the exercise bout

Secondary outcomes (2)
  1. % Body Fat

    this is a descriptive measure of the amount of total body weight that is fat. expressed as a percentage. Since this is a repeated measures study (each subject completed all conditions) this test was only done once before the experimental trials.

    Measured: preliminary testing before beginning the study

  2. Skin Surface Area

    this is a descriptive measure of the amount of total body weight that is fat. expressed as a percentage. Since this is a repeated measures study (each subject completed all conditions) this test was only done once before the experimental trials.

    Measured: preliminary testing completed prior to the study procedures

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Mar 2022
  2. Study start1 May 2022
  3. Primary completion1 Oct 2022
  4. Study completion1 Oct 2022

Resources

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 4
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Model description
Each Subject acts as their own control in a repeated measures design
Masking
None (open label)
Enrolment
12 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05302804
Sponsor's protocol ID
0111-22-FB
Status last verified
Mar 2024
First submitted
17 Mar 2022
Last updated
24 Apr 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Menthol Gel in people with Acute Exercise and Heat Exposure, run by University of Nebraska at 1 site in United States.

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 3 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: finished, as of the sponsor's last update on 24 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Skin Blood Flow (time frame: 10 minutes into exercise bout). 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?
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 24 Apr 2024.

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