Trial Outcomes & Findings for The Influence of Capsaicin Gel During Exercise Within the Heat (NCT NCT05298202)

NCT ID: NCT05298202

Last Updated: 2024-03-15

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 12 participants
• Primary outcome timeframe: 30 minutes into exercise bout
• Results posted on: 2024-03-15

Participant Flow

Participant milestones

Measure	Capsaicin First (1 Day), Washout (7days) Then Hypoallergenic Gel (1 Day). Capsaicin first, then hypoallergenic Gel. All participants will receive both Capsaicin and Control hypoallergenic cream (cross-over design ,randomized order, 7 days washout between) applied to the skin prior to exercise in the heat. both cremes were applied on the skin shoulder to wrist and mid-thigh to ankle.	Hypoallergenic Gel First (1 Day), Washout (7 Days), Then Capsaicin (1 Day) hypoallergenic Gel first, then Capsaicin All participants will receive both Capsaicin and Control hypoallergenic cream (cross-over design ,randomized order, 7 days washout between) applied to the skin prior to exercise in the heat. both cremes were applied on the skin shoulder to wrist and mid-thigh to ankle.
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 Participants n=12 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
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
Weight	86.2 kg STANDARD_DEVIATION 18.9 • n=12 Participants
Height	177.4 cm STANDARD_DEVIATION 6.7 • n=12 Participants
body fat	20 percent body fat STANDARD_DEVIATION 10.2 • n=12 Participants

PRIMARY outcome

Timeframe: 30 minutes into exercise bout

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

Outcome measures

Measure	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Skin Blood Flow	188.4 arbitrary units Standard Deviation 104.9	139.2 arbitrary units Standard Deviation 56.7

PRIMARY outcome

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

Sodium concentrations in collected sweat

Outcome measures

Measure	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Sweat Composition	44.2 mmol/L Standard Deviation 16.4	47.5 mmol/L Standard Deviation 17.5

PRIMARY outcome

Timeframe: pre-post 30 minute exercise bout

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)

Outcome measures

Measure	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Sweat Rate	1.23 Liters per hour Standard Deviation .37	1.43 Liters per hour Standard Deviation .43

PRIMARY outcome

Timeframe: at 30 minutes of exercise

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	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Thermal Perception	2.8 score on a scale Standard Deviation .4	2.5 score on a scale Standard Deviation .5

PRIMARY outcome

Timeframe: at 30 minutes of the exercise bout

average measurements from chest, forearm, and calf thermistors

Outcome measures

Measure	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Average Skin Temperature	37.4 degrees C Standard Deviation .5	37.4 degrees C Standard Deviation .5

PRIMARY outcome

Timeframe: at 30 minutes of the exercise bout

measured with rectal thermistor

Outcome measures

Measure	Capsaicin Gel Application n=12 Participants Capsaicin gel will be applied to the skin prior to exercise in the heat Capsaicin: application of capsaicin gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity	Hypoallergenic Gel Application n=12 Participants A hypoallergenic gel will be applied to the skin prior to exercise in the heat Control Gel: application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle Exercise: treadmill walking 3.5 mph at 5% grade Hot environment: 38°C, 60% relative humidity
Core Temperature	37.8 degrees C Standard Deviation .6	37.8 degrees C Standard Deviation .5

Adverse Events

Capsaicin 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