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The Influence of Capsaicin Gel During Exercise Within the Heat

The Influence of Topical Capsaicin on Thermoregulatory and Perceptual Outcomes During Exercise Within the Heat

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05298202
Enrollment
12
Registered
2022-03-28
Start date
2022-05-25
Completion date
2022-10-01
Last updated
2024-03-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Exercise, Heat Exposure

Keywords

heat exposure, exercise, capsaicin

Brief summary

The purpose of this study is to examine the human thermoregulatory impact of applying a commercially available capsaicin gel 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 capsaicin gel 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 capsaicin and control trials will be separated by a 7-14 day washout period

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 capsaicin, and body composition (hydrostatic weigh, bioelectrical impedance). Visits 2 and 3 will be separated by 7-14 days, randomized, and counterbalanced for experimental (capsaicin) 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 capsaicin 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. EXPERIMENTAL VISIT 1 Visit 1 will take approximately 1 hour. Participants will then complete the physical activity readiness questionnaire (PARQ) to be cleared for physical activity. Participants will have a small amount of the capsaicin 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. 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). EXPERIMENTAL 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 capsaicin 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.

Interventions

BIOLOGICALCapsaicin

application of capsaicin gel from shoulder to wrist and mid thigh to ankle

BIOLOGICALControl Gel

application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle

OTHERExercise

treadmill walking 3.5 mph at 5% grade

38°C, 60% relative humidity

Sponsors

University of Nebraska
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE

Intervention model description

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

Eligibility

Sex/Gender
ALL
Age
19 Years to 45 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* 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 capsaicin * pregnant * breast feeding

Design outcomes

Primary

MeasureTime frameDescription
Skin Blood Flow30 minutes into exercise boutLaser Doppler measurement of skin blood flow on the forearm. This is measured in arbitrary units where higher values represent higher blood flow.
Sweat CompositionFinal 10 minutes of the exercise bout (minutes 20-30 of exercise)Sodium concentrations in collected sweat
Sweat Ratepre-post 30 minute exercise boutTo calculate sweat rate the difference in Nude body weight from pre to post exercise was measured (assuming weight loss is equal to sweat loss)
Thermal Perceptionat 30 minutes of exercisescale 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 ()
Average Skin Temperatureat 30 minutes of the exercise boutaverage measurements from chest, forearm, and calf thermistors
Core Temperatureat 30 minutes of the exercise boutmeasured with rectal thermistor

Countries

United States

Participant flow

Participants by arm

ArmCount
All Participants
All participants will receive both Capsaicin and Control hypoallergenic cream (randomized order, 7 days washout between) applied to the skin prior to exercise in the heat
12
Total12

Baseline characteristics

CharacteristicAll Participants
Age, Continuous28 years
STANDARD_DEVIATION 8
body fat20 percent body fat
STANDARD_DEVIATION 10.2
Height177.4 cm
STANDARD_DEVIATION 6.7
Race and Ethnicity Not Collected— Participants
Region of Enrollment
United States
12 participants
Sex: Female, Male
Female
2 Participants
Sex: Female, Male
Male
10 Participants
Weight86.2 kg
STANDARD_DEVIATION 18.9

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 120 / 12
other
Total, other adverse events
0 / 120 / 12
serious
Total, serious adverse events
0 / 120 / 12

Outcome results

Primary

Average Skin Temperature

average measurements from chest, forearm, and calf thermistors

Time frame: at 30 minutes of the exercise bout

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationAverage Skin Temperature37.4 degrees CStandard Deviation 0.5
Hypoallergenic Gel ApplicationAverage Skin Temperature37.4 degrees CStandard Deviation 0.5
p-value: 0.976ANOVA
Primary

Core Temperature

measured with rectal thermistor

Time frame: at 30 minutes of the exercise bout

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationCore Temperature37.8 degrees CStandard Deviation 0.6
Hypoallergenic Gel ApplicationCore Temperature37.8 degrees CStandard Deviation 0.5
p-value: 0.747ANOVA
Primary

Skin Blood Flow

Laser Doppler measurement of skin blood flow on the forearm. This is measured in arbitrary units where higher values represent higher blood flow.

Time frame: 30 minutes into exercise bout

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationSkin Blood Flow188.4 arbitrary unitsStandard Deviation 104.9
Hypoallergenic Gel ApplicationSkin Blood Flow139.2 arbitrary unitsStandard Deviation 56.7
p-value: 0.284ANOVA
Primary

Sweat Composition

Sodium concentrations in collected sweat

Time frame: Final 10 minutes of the exercise bout (minutes 20-30 of exercise)

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationSweat Composition44.2 mmol/LStandard Deviation 16.4
Hypoallergenic Gel ApplicationSweat Composition47.5 mmol/LStandard Deviation 17.5
p-value: 0.177t-test, 2 sided
Primary

Sweat Rate

To calculate sweat rate the difference in Nude body weight from pre to post exercise was measured (assuming weight loss is equal to sweat loss)

Time frame: pre-post 30 minute exercise bout

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationSweat Rate1.23 Liters per hourStandard Deviation 0.37
Hypoallergenic Gel ApplicationSweat Rate1.43 Liters per hourStandard Deviation 0.43
p-value: 0.122t-test, 2 sided
Primary

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 ()

Time frame: at 30 minutes of exercise

ArmMeasureValue (MEAN)Dispersion
Capsaicin Gel ApplicationThermal Perception2.8 score on a scaleStandard Deviation 0.4
Hypoallergenic Gel ApplicationThermal Perception2.5 score on a scaleStandard Deviation 0.5
p-value: 0.038ANOVA

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026