Menthol Stimulation of Brown Adipose Tissue in Humans: Aim 1

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Regulation of Energy Expenditure

In brief

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.

Key facts

Study ID

NCT07030725

Run by

Indiana University

People needed

12

Starts

2025-03-27

Expected to finish

2025-06-09

Last updated by the study team

2026-08-06

Who can join

Age: 18 and older, up to 40. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Fluency in English
• Participate in 150 minutes or more of at least moderate intensity exercise per week during the previous year. Assessment of moderate intensity physical activity will be determined via the International Physical Activity Questionnaire (i.e., IPAQ) (described in detail in Section 7.0). This questionnaire defines moderate intensity exercise as "activities that take moderate physical effort and make you breathe somewhat harder than normal".
• Body fat ≤ 30% as determined by DEXA scan
• Be cleared for physical activity according to the 2020 Physical Activity Readiness Questionnnaire (PAR-Q+).

You may not qualify if…

• Any autonomic cardiovascular, metabolic, neurologic, endocrine, or respiratory disease, that, in the opinion of the investigator, would exclude them from participation.
• Previously diagnosed liver and/or kidney dysfunction, including, but not limited to, acute and/or chronic kidney disease, cirrhosis, hepatitis, and fatty liver disease.
• Women who are pregnant or breastfeeding.
• Current use of tobacco or electronic cigarette, or regular (i.e., more than twice a week) use within the last 1 year.
• History of peripheral cold injury, skin disorder (eczema, psoriasis), or excessive tattooing.
• Known chronic (i.e., cancer, surgery) or acute conditions (i.e., diarrhea, constipation) of the rectum.
• Menthol allergy (described in detail in Section 7.0 and 9.0). Menthol can cause skin irritation when applied topically, especially for people with sensitive skin or allergies. For this reason, recruited participants will be screened for a menthol allergy during the informed consent/screening visit. We will apply a small quantity of the cream (\~2ml) to an isolated body area to limit skin exposure. In the case a rash develops during the application of the cream, research staff will irrigate the area to remove the substance and limit further exposure. A 24-hour follow-up phone call initiated by research staff will be implemented to follow-up on all adverse reactions. Detectable BAT activation during a localized cold stress test (i.e., face cooling test) (procedure described in detail in Section 7.0).
• Using medications with direct effects on the cardiovascular system including, but not limited to:
• Anticoagulants.
• Antiplatelet agents.
• ACE Inhibitors.
• Angiotensin II receptor blockers.
• Angiotensin-receptor neprilysin inhibitors.
• Beta blockers.
• Calcium, potassium, or sodium channel blockers.
• Cholesterol lowering medications.
• Digitalis preparations.
• Diuretics.
• Vasodilators.
• Anticholinergics.

Where it is running

• Indiana University — Bloomington, Indiana, United States

Full record on ClinicalTrials.gov

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