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New treatment option for Regulation of Energy Expenditure
Official title Menthol Stimulation of Brown Adipose Tissue in Humans: Aim 1
ClinicalTrials.gov ID: NCT07030725
What this study is testing
What is Menthol Gel?
Menthol Gel is an investigational medicine, given as a treatment applied to the skin, being studied as a potential treatment for regulation of energy expenditure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 40. Healthy volunteers may be eligible.
You may be able to join 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...
- Body fat ≤ 30% as determined by DEXA scan
- Be cleared for physical activity according to the 2020 Physical Activity Readiness Questionnnaire (PAR-Q+).
You likely can't join if
- Any autonomic cardiovascular, metabolic, neurologic, endocrine, or respiratory disease, that, in the opinion of the investigator, would exclude them...
- Previously diagnosed liver and/or kidney dysfunction, including, but not limited to, acute and/or chronic kidney disease, cirrhosis, hepatitis, and...
- 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.
See the full eligibility 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...
- 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...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Bloomington, Indiana, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 40 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Bloomington, Indiana, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.