Study of Metabolic Content of Urine

Sponsor
University of Wisconsin, Madison (Other)
Overall Status
Recruiting
CT.gov ID
NCT05637840
Collaborator
Morgridge Institute for Research (Other)
20
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2
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Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Urine sample
  • Other: Sleep restriction
N/A

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
Anticipated Enrollment :
20 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Longitudinal Study of Metabolic Content of Human Urine
Actual Study Start Date :
Dec 6, 2022
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Sleep limited

Participants will be asked to limit their sleep

Other: Urine sample
Collection of 36-84 urine samples over a 14 consecutive day period.

Other: Sleep restriction
Participants will be asked to limit their sleep to 4 hours within a 24-hour period for 2 days in a row.

Experimental: No sleep limitation

Participants will be asked to get their normal amount of sleep.

Other: Urine sample
Collection of 36-84 urine samples over a 14 consecutive day period.

Outcome Measures

Primary Outcome Measures

  1. Change in inflammation [Baseline to day 14]

    Changes in inflammation will be measured by hs-CRP via short-term sleep restriction.

  2. Correlate biohealth data with concentrations of urine metabolites [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Wisconsin Madison Wisconsin United States 53705

Sponsors and Collaborators

  • University of Wisconsin, Madison
  • Morgridge Institute for Research

Investigators

  • Principal Investigator: Joshua Coon, MD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT05637840
Other Study ID Numbers:
  • 2022-1111
  • A537700
  • SMPH/BIOMOLEC CHEM/BIOMOL CHM
  • Protocol Version 9/28/22
First Posted:
Dec 5, 2022
Last Update Posted:
Jan 13, 2023
Last Verified:
Jan 1, 2023
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Jan 13, 2023