Clinical trial

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

Name

0111-22-FB

Description

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

Trial arms

Trial start

2022-05-01

Estimated PCD

2022-10-01

Trial end

2022-10-01

Status

Completed

Phase

Early phase I

Treatment

Menthol Gel

5% menthol gel applied from shoulder to wrist and mid thigh to ankle, 30 minute treadmill walk (3.5 mph at 5% grade at 38°C, 60% relative humidity)

Arms:

Hypoallergenic Gel first, then menthol, Menthol Gel first, then hypoallergenic gel

Other names:

BioFreeze

Control Gel

Hypoallergenic gel applied from shoulder to wrist and mid thigh to ankle, 30 minute treadmill walk (3.5 mph at 5% grade at 38°C, 60% relative humidity)

Arms:

Hypoallergenic Gel first, then menthol, Menthol Gel first, then hypoallergenic gel

Other names:

placebo

Size

Primary endpoint

Skin Blood Flow

10 minutes into exercise bout

Skin Blood Flow

30 minutes into exercise bout

Galvanic Skin Response

Time to 40 micro-siemens

Sweat Composition

final 10 minutes of exercise bout

Sweat Rate

pre to post exercise, approximately 30 minutes

Thermal Perception

throughout the 30 minute exercise bout

Average Skin Temperature

after 30 minutes of exercise

Core Temperature

after 30min exercise

Sweat Potassium Concentration

final 10 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 menthol based gels 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 menthol gels * 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

2024-04-24

1 organization

2 products

2 indications

Organization

University of Nebraska

Product

Indication

Indication

Product