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Clinical Trials/NCT05637840
NCT05637840CompletedNot Applicable

Longitudinal Study of Metabolic Content of Human Urine

University of Wisconsin, Madison2 sites in 1 country25 target enrollmentStarted: December 6, 2022Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
25
Locations
2
Primary Endpoint
Change in inflammation

Study Overview

Brief 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. 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

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Basic Science
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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

Outcomes

Primary Outcomes

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.

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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