Menthol Gel for Metabolism

Overseen By Felipe Pereira, MS

Age: 18 - 65

Sex: Any

Trial Phase: Phase < 1

Sponsor: Indiana University

Must not be taking: Blood pressure, Cholesterol, Anticholinergics, others

Disqualifiers: Cardiovascular, Metabolic, Neurologic, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

Duration: 1 day

24 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Brown adipose tissue becomes activated during cold conditions to increase thermogenesis (i.e., energy expenditure). Topical menthol application increases resting energy expenditure but it is unclear whether brown adipose tissue activation contributes to this rise in the energy expenditure. The overall goal with this project is to determine whether topical menthol application stimulates brown adipose tissue.

Who Is on the Research Team?

Blair D Johnson, PhD

Principal Investigator

Indiana University

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who are physically active, with a body fat percentage of 30% or less. They must not have any menthol allergy, be pregnant or breastfeeding, use tobacco products, have certain skin disorders or tattoos that could interfere with the study, nor should they have cardiovascular, metabolic, neurologic, endocrine or respiratory diseases.

Inclusion Criteria

Fluency in English

Cleared for physical activity according to the 2020 Physical Activity Readiness Questionnaire (PAR-Q+)

Participation in 150 minutes or more of at least moderate intensity exercise per week during the previous year as determined by the International Physical Activity Questionnaire (IPAQ)

Exclusion Criteria

Menthol allergy

Pregnant or breastfeeding women

Current use of tobacco or electronic cigarette, or regular use within the last 1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive topical menthol or sham cream application to the anterior upper body

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 hours

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Menthol Gel

Trial Overview The study aims to see if applying menthol gel on the skin can stimulate brown adipose tissue (a type of fat that generates heat) and increase energy expenditure in humans. Participants will also experience time control and sham treatments for comparison.

How Is the Trial Designed?

Group I: Time control Experimental Treatment 1 Intervention

No cream applied to the anterior upper body.

Group II: Menthol Experimental Treatment 1 Intervention

Menthol (5% L-menthol) applied to the anterior upper body, excluding the arms, head, and neck.

Group III: Sham Placebo Group 1 Intervention

A sham cream applied to the anterior upper body, excluding the arms, head, and neck.

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials

1,063

Recruited

1,182,000+