Completed

NCT Number: NCT02935894

Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat

The purpose of this study is to see what the differences are in sweat (amount and small molecule content) collected from different sites of the body and by different methods of sweat stimulation. Additionally, the investigators want to know whether the amount and small molecule content of the sweat is the same in an individual over time, and the same across individuals at a given time. Finally, the investigators want to know how consumption of over-the-counter anti-inflammatory drugs such as ibuprofen will affect the inflammatory mediator content of sweat and how that compares to blood. This information will help to better understand the composition and behavior of sweat and assess its potential utility as a routine clinical tool in skin research.

Completed

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Key information

Conditions

Stability & Variability of Lipid-derived Molecules in Sweat

Age range

20 year–40 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Western Human Nutrition Research Center

Davis, California, 95616, United States

About this study

Subjects will participate in 4 study day visits that will be scheduled about 1- week apart. During the first study visit, the investigators will compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological stimulation of sweating (using a stationary bicycle). During the second study visit, the investigators will collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) and also the upper surface of the thigh (near the knee). During the third study visit, the investigators will collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist). During the fourth study visit, the investigators will collect a sweat sample following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) and a blood sample (about one teaspoon) from the other arm. After blood and sweat collection, participants will consume 400 mg (two tablets) of ibuprofen. The investigators will then collect blood and sweat from 30 minutes, 2 hours and 4 hours after participants consume the ibuprofen.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

20-40 y
Male
Weight > 110 pounds

Exclusion criteria

Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:

Diabetes mellitus
Cardiovascular disease
Cancer
Gastrointestinal disorders
Kidney disease
Liver disease
Bleeding disorders
Asthma
Autoimmune disorders
Hypertension
Osteoporosis
Recent minor surgery (within 4 wk) or major surgery (within 16 wk)
Recent antibiotic therapy (within 4 wk)
Recent hospitalization (within 4 wk)
Use of over-the-counter or prescription medications at the time of the study that directly affect endpoints of interest (e.g. hyperlipidemia, glycemic control, steroids, statins, anti-inflammatory agents, and weight loss aids)
Adults who are not able to consent
Under current medical supervision
Ibuprofen intolerance or allergy
Those with a bleeding disorder
Current enrollee in a clinical research study.
Individuals with blood clotting or platelet defect disorders
Individuals with orthopedic limitations or cardiovascular risk that preclude participation in the physiological stimulation of sweat by light exercise portion of the study
Individuals who are trained athletes or that regularly perform physical activity defined as "vigorous" by the Centers for Disease Control and Prevention

Treatment and study plan

Ibuprofen

Drug

400 mg ibuprofen given to inhibit cyclooxygenase metabolism

Physiological induction of sweating

Other

15 minutes exercise at 60-80% oxygen consumption to induce sweating

Other names: Exercise

Pilocarpine

Drug

Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating

Other names: Pilogel

Primary outcomes

Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

Time frame: measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported

Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.
Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise

Time frame: measured at study visit 1, detected lipid mediator concentrations reported

Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.
Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

Time frame: measured at study visit 1, detected lipid mediator concentrations reported

Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.
Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation

Time frame: measured at study visit 2, detected lipid mediator concentrations reported

Approximately 150 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids and endocannabinoid-like molecules, and sphingolipids.
Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration

Time frame: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported

Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.

Secondary outcomes

Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration

Time frame: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported

Approximately 100 lipid mediators will be measured by liquid chromatography-tandem mass spectrometry (LC-MS/MS). Assayed lipid mediators include oxygenated lipids, endocannabinoids, and endocannabinoid-like molecules.
Change in Plasma Ibuprofen Concentrations

Time frame: measured at four timepoints at study visit 4

Plasma concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration
Change in Sweat Ibuprofen Concentrations

Time frame: measured at four timepoints at study visit 4

Sweat concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration

Sponsors and collaborators

Lead sponsor

USDA, Western Human Nutrition Research Center

Fed

Collaborators

University of California, Davis

Registry information

Important dates

Study start: 2016
Primary completion: 2017
Study completion: 2017
First posted: Oct 18, 2016
Registry last updated: Jun 1, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.