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

NCT ID: NCT02935894

Last Updated: 2018-06-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-28
• Study Completion Date: 2017-06-08

Brief Summary

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.

Detailed Description

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.

Conditions

Stability & Variability of Lipid-derived Molecules in Sweat

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

Single group

All subjects will participate in 4 study day visits in the same order.

1. compare sweat collected following pharmacological stimulation of sweating (using the drug pilocarpine) to sweat collected following physiological induction of sweating (exercise using a stationary bicycle).

2. compare sweat collected following stimulation of sweating by the drug pilocarpine from the inner part of the forearm (near the wrist) to upper surface of thigh (near the knee).

3. collect sweat following stimulation of sweating by the drug pilocarpine from the inner part of both forearms (near the wrist).

4. collect blood and sweat samples before and 30 minutes, 2 hours and 4 hours after consumption of 400 mg of ibuprofen.

Group Type: EXPERIMENTAL

Ibuprofen

Intervention Type: DRUG

400 mg ibuprofen given to inhibit cyclooxygenase metabolism

Physiological induction of sweating

Intervention Type: OTHER

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

Pilocarpine

Intervention Type: DRUG

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

Interventions

Ibuprofen

400 mg ibuprofen given to inhibit cyclooxygenase metabolism

Intervention Type: DRUG

Physiological induction of sweating

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

Intervention Type: OTHER

Pilocarpine

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

Intervention Type: DRUG

Other Intervention Names

Exercise; Pilogel

Eligibility Criteria

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

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of California, Davis

OTHER

Sponsor Role: collaborator

USDA, Western Human Nutrition Research Center

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John W. Newman, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

USDA-ARS-Western Human Nutrition Research Center

Locations

Western Human Nutrition Research Center

Davis, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Informed Consent Form

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

929370

Identifier Type: -

Identifier Source: org_study_id