The Influence of Capsaicin Gel During Exercise Within the Heat

NCT05298202 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 0192-22-FB
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

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

Conditions

Acute Exercise; Heat Exposure

Keywords

heat exposure; exercise; capsaicin

Outcome Measures

Primary Outcomes (6)

• 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.

  30 minutes into exercise bout

• Sweat Composition

  Sodium concentrations in collected sweat

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

• 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)

  pre-post 30 minute exercise bout

• 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 "()"

  at 30 minutes of exercise

• Average Skin Temperature

  average measurements from chest, forearm, and calf thermistors

  at 30 minutes of the exercise bout

• Core Temperature

  measured with rectal thermistor

  at 30 minutes of the exercise bout

Study Arms (2)

Capsaicin gel application

EXPERIMENTAL

Capsaicin gel will be applied to the skin prior to exercise in the heat

Biological: Capsaicin; Other: Exercise; Other: Hot environment

Hypoallergenic gel application

PLACEBO COMPARATOR

A hypoallergenic gel will be applied to the skin prior to exercise in the heat

Biological: Control Gel; Other: Exercise; Other: Hot environment

Interventions

Capsaicin BIOLOGICAL

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

Capsaicin gel application

Control Gel BIOLOGICAL

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

Hypoallergenic gel application

Exercise OTHER

treadmill walking 3.5 mph at 5% grade

Capsaicin gel application; Hypoallergenic gel application

Hot environment OTHER

38°C, 60% relative humidity

Capsaicin gel application; Hypoallergenic gel application

Eligibility Criteria

• Age: 19 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nebraska: lead

Study Sites (1)

University of Nebraska at Omaha

Omaha, Nebraska, 68182, United States

Location

MeSH Terms

Conditions

Motor Activity

Interventions

Capsaicin; Exercise

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Polyunsaturated Alkamides; Amides; Organic Chemicals; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Catechols; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Fatty Acids, Monounsaturated; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dustin Slivka
• Organization: University of Montana

dustin.slivka@umontana.edu

(406) 243-2389

Study Officials

• Dustin R Slivka, PHD

  University of Nebraska

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 17, 2022
• First Posted: March 28, 2022
• Study Start: May 25, 2022
• Primary Completion: October 1, 2022
• Study Completion: October 1, 2022
• Last Updated: March 15, 2024
• Results First Posted: March 15, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)