RECRUITING

Menthol Stimulation of Brown Adipose Tissue in Humans: Aim 1

Conditions

Regulation of Energy Expenditure menthol brown adipose tissue energy expenditure

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Targeted TRPM8 Stimulation and Brown Adipose Tissue Activation in Humans

Quick Facts

Study Start:2025-03-27

Study Completion:2026-09

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07030725

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 40 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:Yes

Standard Ages:ADULT

Inclusion Criteria	Exclusion Criteria
* 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+).	* 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.

Inclusion Criteria

Exclusion Criteria

* 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+).

* 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.

Contacts and Locations

Study Contact

Felipe Pereira, MS

CONTACT

812-855-8699

hiplab@iu.edu

Principal Investigator

Blair D Johnson, PhD

PRINCIPAL_INVESTIGATOR

Indiana University

Study Locations (Sites)

Indiana University

Bloomington, Indiana, 47405

United States

Collaborators and Investigators

Sponsor: Indiana University

Blair D Johnson, PhD, PRINCIPAL_INVESTIGATOR, Indiana University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-27

Study Completion Date2026-09

Study Record Updates

Study Start Date2025-03-27

Study Completion Date2026-09

Terms related to this study

Keywords Provided by Researchers

menthol
brown adipose tissue
energy expenditure

Additional Relevant MeSH Terms

Regulation of Energy Expenditure