Metabolic Content of UrineNCT05637840
Study of Metabolic Content of Urine
A study testing Urine sample and Sleep restriction in people with Metabolic Content of Urine, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
The purpose of this research study is to test the different components in urine and see if they can be matched to food, exercise and sleep that participants report. The researchers are trying to find out if urine would allow them to predict medical problems as they are happening. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolic Content of Urine
- What is being tested?
- Urine sample and Sleep restriction
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Dec 2022to 18 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Must be 18 years or older
- Be able to provide informed consent
- Stated willingness to comply with all study procedures and have availability for the duration of the study
Who cannot join
- Presence of a condition(s) or diagnosis, either physical or psychological, that limits the ability to urinate in the collection apparatus
- Individuals who do not consistently get at least 6 hours of sleep per night
- Individuals who have a sleep disorder diagnosis.
- Individuals who live in the state of New York
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Longitudinal Study of Metabolic Content of Human Urine
The purpose of this research study is to test the different components in urine and see if they can be matched to food, exercise and sleep that participants report. The researchers are trying to find out if urine would allow them to predict medical problems as they are happening. Participants are healthy volunteers who are willing to give urine samples on a daily basis, and can expect to be in the study for 28 days.
Read the detailed description
The purpose of this research study is to analyze urine samples using Mass Spectrometry to identify metabolites that have the potential to be used for medical diagnosis. This data, along with data from wearable devices, will be combined and analyzed to correlate what an individual does on a daily basis with how their body metabolizes their choices. This type of data may provide insights into the origins and progression of diseases in a short time span.
- Conditions
- Metabolic Content of Urine
- Being tested
- Urine sample, Sleep restriction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Urine sampleOther
Collection of 36-84 urine samples over a 14 consecutive day period.
Sleep restrictionOther
Participants will be asked to limit their sleep to 4 hours within a 24-hour period for 2 days in a row.
| Study group | Role | What they receive |
|---|---|---|
| Sleep limited | Experimental | Participants will be asked to limit their sleep Receives: Other: Urine sample; Other: Sleep restriction |
| No sleep limitation | Experimental | Participants will be asked to get their normal amount of sleep. Receives: Other: Urine sample |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in inflammation
Changes in inflammation will be measured by hs-CRP via short-term sleep restriction.
Measured: Baseline to day 14
Correlate biohealth data with concentrations of urine metabolites
To explore connections between urine metabolite concentrations and others measures of health and lifestyle, biometric data will be collected using a FitBit watch (sleep and exercise), nutritional data (food logs) and a questionnaire (tobacco use). Urine will be analyzed using mass spectrometry to isolate metabolites. The metabolites will then be cross-referenced against databases of known metabolites in order to identify them and their disease associations.
Measured: Daily for 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2022
- Study start6 Dec 2022
- Primary completion18 Nov 2023
- Study completion18 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic Content of UrineStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- Morgridge Institute for Research
- Responsible party
- Sponsor
- Investigators
- Joshua Coon, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05637840
- Sponsor's protocol ID
- 2022-1111
- Other IDs
- A537700, SMPH/BIOMOLEC CHEM/BIOMOL CHM, Protocol Version 9/28/22
- Status last verified
- Feb 2024
- First submitted
- 22 Nov 2022
- Last updated
- 16 Feb 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Study of Metabolic Content of Human Urine
- ClinicalTrials.gov ID
- NCT05637840
- Acronym / sponsor ID
- 2022-1111
- Conditions
- Metabolic Content of Urine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- Morgridge Institute for Research
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- 18 Nov 2023 (actual)
- Study completion
- 18 Nov 2023 (actual)
- First posted
- 5 Dec 2022 (actual)
- Results
- Not posted in the source record
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 research study is to test the different components in urine and see if they can be matched to food, exercise and sleep that participants report. The researchers are trying to find out if urine would allow them to predict medical problems as they are happening. Participants are healthy volunteers who are willing to give urine samples on a daily basis, and can expect to be in the study for 28 days.
Detailed description
The purpose of this research study is to analyze urine samples using Mass Spectrometry to identify metabolites that have the potential to be used for medical diagnosis. This data, along with data from wearable devices, will be combined and analyzed to correlate what an individual does on a daily basis with how their body metabolizes their choices. This type of data may provide insights into the origins and progression of diseases in a short time span.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep limited | Experimental | Other: Urine sample, Other: Sleep restrictionParticipants will be asked to limit their sleep |
| No sleep limitation | Experimental | Other: Urine sampleParticipants will be asked to get their normal amount of sleep. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Must be 18 years or older
- Be able to provide informed consent
- Stated willingness to comply with all study procedures and have availability for the duration of the study
Key exclusion criteria (4 listed)
- Presence of a condition(s) or diagnosis, either physical or psychological, that limits the ability to urinate in the collection apparatus
- Individuals who do not consistently get at least 6 hours of sleep per night
- Individuals who have a sleep disorder diagnosis.
- Individuals who live in the state of New York
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 |
|---|---|---|
| Urine sampleCollection of 36-84 urine samples over a 14 consecutive day period. | Other | No sleep limitation, Sleep limited |
| Sleep restrictionParticipants will be asked to limit their sleep to 4 hours within a 24-hour period for 2 days in a row. | Other | Sleep limited |
Primary outcome
Change in inflammation
Time frame: Baseline to day 14
Changes in inflammation will be measured by hs-CRP via short-term sleep restriction.
Correlate biohealth data with concentrations of urine metabolites
Time frame: Daily for 14 days
To explore connections between urine metabolite concentrations and others measures of health and lifestyle, biometric data will be collected using a FitBit watch (sleep and exercise), nutritional data (food logs) and a questionnaire (tobacco use). Urine will be analyzed using mass spectrometry to isolate metabolites. The metabolites will then be cross-referenced against databases of known metabolites in order to identify them and their disease associations.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2024.
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.
Joshua Coon, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Urine sample and Sleep restriction in people with Metabolic Content of Urine, run by University of Wisconsin, Madison 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 4 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 16 Feb 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in inflammation (time frame: Baseline to day 14). The study lists 2 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 16 Feb 2024.