Clinical trial

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

Name
0192-22-FB
Description
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
Trial arms
Trial start
2022-05-25
Estimated PCD
2022-10-01
Trial end
2022-10-01
Status
Completed
Phase
Early phase I
Treatment
Capsaicin
application of capsaicin gel from shoulder to wrist and mid thigh to ankle
Arms:
Capsaicin gel application
Control Gel
application of hypoallergenic gel from shoulder to wrist and mid thigh to ankle
Arms:
Hypoallergenic gel application
Exercise
treadmill walking 3.5 mph at 5% grade
Arms:
Capsaicin gel application, Hypoallergenic gel application
Hot environment
38°C, 60% relative humidity
Arms:
Capsaicin gel application, Hypoallergenic gel application
Size
12
Primary endpoint
Skin Blood Flow
30 minutes into exercise bout
Sweat Composition
Final 10 minutes of the exercise bout (minutes 20-30 of exercise)
Sweat Rate
pre-post 30 minute exercise bout
Thermal Perception
at 30 minutes of exercise
Average Skin Temperature
at 30 minutes of the exercise bout
Core Temperature
at 30 minutes of the exercise bout
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Each Subject acts as their own control in a repeated measures design', 'primaryPurpose': 'BASIC_SCIENCE', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 12, 'type': 'ACTUAL'}}
Updated at
2024-03-15

1 organization

2 products

2 indications

Product
Capsaicin
Indication
Acute Exercise
Indication
Heat Exposure