24 Participants Needed

Menthol Gel for Metabolism

FP
Overseen ByFelipe Pereira, MS
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if applying a menthol gel can activate brown adipose tissue, a type of fat that burns calories to generate heat. Researchers are investigating whether the cooling effect of menthol can increase energy use in the body. Participants will be divided into three groups: one using menthol gel, one using a sham cream (a non-active cream), and one using no cream. Individuals who work out regularly and have a body fat percentage of 30% or less may be suitable for this trial. As an Early Phase 1 trial, this research focuses on understanding how menthol gel works in people, offering participants the opportunity to be among the first to explore its effects.

Will I have to stop taking my current medications?

If you are taking medications that affect the cardiovascular system, such as blood pressure or cholesterol medications, you may not be eligible to participate in the trial. The protocol does not specify a washout period, but these medications are listed as exclusion criteria.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that menthol gel is usually safe when applied to the skin. Studies suggest that menthol is unlikely to cause allergic skin reactions. No strong evidence links menthol to cancer or genetic harm in humans. However, menthol can sometimes irritate the skin and eyes, especially if used incorrectly or in large amounts. Overall, menthol is commonly used in many products and is considered safe when used as directed.12345

Why do researchers think this study treatment might be promising?

Unlike typical treatments for boosting metabolism, which often involve dietary changes, exercise, or pharmaceutical interventions, the menthol gel introduces a novel approach by using a topical application. This gel contains 5% L-menthol, which is applied directly to the skin and could potentially stimulate metabolism through local cooling effects. Researchers are excited about this treatment because it offers a non-invasive, easy-to-use alternative that might activate thermogenesis without the need for systemic medication or lifestyle alterations. This unique mechanism could pave the way for a new category of metabolism-enhancing therapies.

What evidence suggests that menthol gel might be an effective treatment for metabolism?

Research has shown that applying menthol to the skin can help the body burn more calories by producing heat. In past studies, menthol application increased people's metabolic rate, leading to higher energy use. Evidence also suggests that menthol might activate brown fat, a type of fat that burns calories to maintain body warmth. One study found that using menthol on the skin increased brown fat activity and helped reduce weight gain. However, while these findings are promising, researchers continue to investigate whether the increase in energy use is directly due to brown fat activation. In this trial, participants will be assigned to different groups, including a menthol gel application, a sham cream, or no cream, to further explore these effects.678910

Who Is on the Research Team?

BD

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)
See 1 more

Exclusion Criteria

Menthol allergy
Pregnant or breastfeeding women
Current use of tobacco or electronic cigarette, or regular use within the last 1 year
See 6 more

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?
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Time controlExperimental Treatment1 Intervention
Group II: MentholExperimental Treatment1 Intervention
Group III: ShamPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Indiana University

Lead Sponsor

Trials
1,063
Recruited
1,182,000+

Citations

1.pubmed.ncbi.nlm.nih.govpubmed.ncbi.nlm.nih.gov/26429629/
The absorption and metabolism of a single L-menthol oral ...We conclude that a single L-menthol skin administration increased thermogenesis and metabolic rate in humans. These effects are minor following L-menthol oral ...
The absorption and metabolism of a single L-menthol oral ...We conclude that a single L-menthol skin administration increased thermogenesis and metabolic rate in humans. These effects are minor following L-menthol oral ...
Menthol Stimulation of Brown Adipose Tissue in Humans ...Moreover, Valente et. al observed an increase in metabolic rate in humans following a single administration of menthol to the skin surface of the neck and of ...
Topical application of the pharmacological cold mimetic ...3 RESULTS. 3.1 Topical menthol application increases brown adipose tissue thermogenesis and attenuates weight gain. Conflicting reports ...
Menthol Gel for MetabolismTopical menthol application increases resting energy expenditure but it is unclear whether brown adipose tissue activation contributes to this rise in the ...
SAFETY DATA SHEET - Grove MedicalNot expected to cause skin sensitization. Germ Cell mutagenicity. No data available. Carcinogenicity. Not classifiable as carcinogenic to humans. Reproductive ...
SAFETY DATA SHEETOSHA: No component of this product present at levels greater than or equal to 0.1% is on OSHA's list of regulated carcinogens. Reproductive ...
Safety Data SheetRTECS Number. 89-78-1 (±)-Menthol OT0350000. · Information on toxicological effects. · Acute toxicity: · LD/LC50 values that are relevant for ...
Safety Data SheetRefer to Section 8.Do not eat, drink, smoke, or use personal products when handling chemical. Page 4. Safety Data Sheet according to 29CFR1910/ ...
Menthol SDS, 1490-04-6 Safety Data SheetsThis compound may be harmful by inhalation, ingestion or skin absorption. It is an irritant of the skin and eyes. It is also irritating to the mucous membranes ...
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