Stability & Variability of Lipid-derived Molecules in SweatNCT02935894
Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat
A study testing Ibuprofen, Physiological induction of sweating and Pilocarpine in people with Stability & Variability of Lipid-derived Molecules in Sweat, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Stability & Variability of Lipid-derived Molecules in Sweat
- What is being tested?
- Ibuprofen, Physiological induction of sweating and Pilocarpine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Nov 2016to 8 Jun 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 20-40 y
- Male
- Weight > 110 pounds
Who cannot join
- 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
Show all 24Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Human Nutrition Research Center
Davis, California, 95616
About this study
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.
Read the 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.
- Being tested
- Ibuprofen, Physiological induction of sweating, Pilocarpine
- Keywords
- oxygenated lipids, metabolic profiling, sphingoid bases, ceramides, endocannabinoids, non-invasive sampling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IbuprofenDrug
400 mg ibuprofen given to inhibit cyclooxygenase metabolism
Physiological induction of sweatingOther
Also called Exercise
15 minutes exercise at 60-80% oxygen consumption to induce sweating
PilocarpineDrug
Also called Pilogel
Iontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating
| Study group | Role | What they receive |
|---|---|---|
| Single group | Experimental | 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. Receives: Drug: Ibuprofen; Other: Physiological induction of sweating; Drug: Pilocarpine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volar Forearm Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation
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.
Measured: measured at study visit 1, 2 and 3; detected lipid mediator concentrations for study visit 1 reported
Volar Forearm Sweat Lipid Mediator Concentrations Following Exercise
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.
Measured: measured at study visit 1, detected lipid mediator concentrations reported
Lower Back Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation
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.
Measured: measured at study visit 1, detected lipid mediator concentrations reported
Anterior Distal Thigh Sweat Lipid Mediator Concentrations Following Pilocarpine Stimulation
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.
Measured: measured at study visit 2, detected lipid mediator concentrations reported
Change in Plasma Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration
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.
Measured: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported
Secondary outcomes (3)
Change in Pilocarpine-stimulated Sweat Lipid Mediator Concentrations Before and After Oral Ibuprofen Administration
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.
Measured: measured at four timepoints at study visit 4, detected lipid mediator concentrations for first timepoint reported
Change in Plasma Ibuprofen Concentrations
Plasma concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration
Measured: measured at four timepoints at study visit 4
Change in Sweat Ibuprofen Concentrations
Sweat concentration of ibuprofen prior to and 30 min, 2 hr and 4 hr after oral administration
Measured: measured at four timepoints at study visit 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Oct 2016 (estimated)
- Study start28 Nov 2016
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Stability & Variability of Lipid-derived Molecules in SweatStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- USDA, Western Human Nutrition Research Center
- Sponsor type
- US federal agency
- Collaborators
- University of California, Davis
- Responsible party
- Sponsor
- Investigators
- John W. Newman, Ph.D., Principal investigator, USDA-ARS-Western Human Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02935894
- Sponsor's protocol ID
- 929370
- Status last verified
- Apr 2018
- First submitted
- 12 Oct 2016
- Last updated
- 1 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Stability, Variability and Mechanism of Incorporation of Lipid Mediators Into Eccrine Sweat
- ClinicalTrials.gov ID
- NCT02935894
- Acronym / sponsor ID
- 929370
- Keywords
- oxygenated lipids, metabolic profiling, sphingoid bases, ceramides, endocannabinoids, non-invasive sampling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- USDA, Western Human Nutrition Research CenterUS federal agency
- Collaborators
- University of California, Davis
- Study start
- 28 Nov 2016 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 18 Oct 2016 (estimated)
- Results
- Posted 1 Jun 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single group | Experimental | Drug: Ibuprofen, Other: Physiological induction of sweating, Drug: PilocarpineAll 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. |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 20-40 y
- Male
- Weight > 110 pounds
Key exclusion criteria (24 listed)
- Diagnosed active chronic diseases for which the individual is currently taking daily medication, including but not limited to:
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ibuprofen400 mg ibuprofen given to inhibit cyclooxygenase metabolism | Drug | Single group |
| Physiological induction of sweatingAlso: Exercise15 minutes exercise at 60-80% oxygen consumption to induce sweating | Other | Single group |
| PilocarpineAlso: PilogelIontophoresis with a 1.5 milliampere (mA) current using a gel disc containing a 5% pilocarpine nitrate solution to induce sweating | Drug | Single group |
Primary outcome
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.
3 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
Change in Plasma Ibuprofen Concentrations
Time frame: measured at four timepoints at study visit 4
Change in Sweat Ibuprofen Concentrations
Time frame: measured at four timepoints at study visit 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
John W. Newman, Ph.D. principal investigator
USDA-ARS-Western Human Nutrition Research Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ibuprofen, Physiological induction of sweating and Pilocarpine in people with Stability & Variability of Lipid-derived Molecules in Sweat, run by USDA, Western Human Nutrition Research Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Jun 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2018.