Trial Outcomes & Findings for The Influence of Menthol Gel During Exercise With Heat (NCT NCT05302804)

NCT ID: NCT05302804

Last Updated: 2024-04-24

Results Overview

Laser Doppler measurement of skin blood flow

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: 10 minutes into exercise bout
• Results posted on: 2024-04-24

Participant Flow

Participant milestones

Measure	Menthol Gel First, Then Hypoallergenic Gel Participants randomized to receive menthol gel first then hypoallergenic gel after 7 day washout. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade	Hypoallergenic Gel First, Then Menthol Participants randomized to receive hypoallergenic gel first then menthol gel after 7 day washout. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade
Overall Study STARTED	6	6
Overall Study COMPLETED	6	6
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	All Study Participants n=12 Participants Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade A hypoallergenic gel will be applied to the skin prior to exercise in the heat
Age, Categorical <=18 years	0 Participants n=12 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=12 Participants
Age, Categorical >=65 years	0 Participants n=12 Participants
Age, Continuous	28 years STANDARD_DEVIATION 8 • n=12 Participants
Sex: Female, Male Female	2 Participants n=12 Participants
Sex: Female, Male Male	10 Participants n=12 Participants
Region of Enrollment United States	12 participants n=12 Participants
Body Composition	20.1 percent body fat STANDARD_DEVIATION 6.3 • n=12 Participants

PRIMARY outcome

Timeframe: 10 minutes into exercise bout

Laser Doppler measurement of skin blood flow

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Skin Blood Flow	131.6 arbitrary units Standard Deviation 71.6	119.2 arbitrary units Standard Deviation 43.2

PRIMARY outcome

Timeframe: 30 minutes into exercise bout

Laser Doppler measurement of skin blood flow

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Skin Blood Flow	196.1 arbitrary units Standard Deviation 69.4	194.8 arbitrary units Standard Deviation 73.3

PRIMARY outcome

Timeframe: Time to 40 micro-siemens

measurement of skin conductance

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Galvanic Skin Response	1299 seconds Standard Deviation 335	1148 seconds Standard Deviation 298

PRIMARY outcome

Timeframe: final 10 minutes of exercise bout

Sodium concentrations in collected sweat

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Sweat Composition	38.9 mmol/L Standard Deviation 13.8	43.9 mmol/L Standard Deviation 6.9

PRIMARY outcome

Timeframe: pre to post exercise, approximately 30 minutes

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.

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Sweat Rate	1.1 Liters per hour Standard Deviation 0.4	1.3 Liters per hour Standard Deviation .4

PRIMARY outcome

Timeframe: throughout the 30 minute exercise bout

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 "()"

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Thermal Perception	0.7 units on a scale Standard Deviation 1.6	1.8 units on a scale Standard Deviation 1.3

PRIMARY outcome

Timeframe: after 30 minutes of exercise

average measurements from chest, forearm, and calf thermistors

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Average Skin Temperature	37.6 degrees C Standard Deviation .3	37.2 degrees C Standard Deviation .5

PRIMARY outcome

Timeframe: after 30min exercise

measured with rectal thermistor

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Core Temperature	38.1 degrees C Standard Deviation .3	37.7 degrees C Standard Deviation .3

PRIMARY outcome

Timeframe: final 10 minutes of the exercise bout

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

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel n=12 Participants Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Sweat Potassium Concentration	7.1 mmol/L Standard Deviation 1.2	6.9 mmol/L Standard Deviation 1.7

SECONDARY outcome

Timeframe: preliminary testing before beginning the study

Population: There is only 1 arm for this variable since it is descriptive of the total subjects that subsequently participate in each condition (repeated-measures).

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.

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
% Body Fat	20.1 percent body fat Standard Deviation 6.3	—

SECONDARY outcome

Timeframe: preliminary testing completed prior to the study procedures

Population: There is only 1 arm for this variable since it is descriptive of the total subjects that subsequently participate in each condition (repeated-measures).

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.

Outcome measures

Measure	Menthol Gel n=12 Participants Menthol Gel: application of 5% menthol gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade	Control Gel Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Menthol gel will be applied to the skin or a A hypoallergenic control gel will be applied to the skin prior to exercise in the heat. All subjects complete both menthol gel and hypoallergenic control gel conditions in a randomized cross-over study design. At least 7 days were allowed between conditions (washout). Exercise: treadmill walking 3.5 mph at 5% grade
Skin Surface Area	1.98 meters squared Standard Deviation .31	—

Adverse Events

Menthol Gel Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Hypoallergenic Gel Application

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dustin Slivka

University of Montana

Phone: (406) 243-2389

Email: dustin.slivka@umontana.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place