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Study of Metabolic Content of Urine

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05637840
Recruitment Status : Recruiting
First Posted : December 5, 2022
Last Update Posted : January 13, 2023
Sponsor:
Collaborator:
Morgridge Institute for Research
Information provided by (Responsible Party):
University of Wisconsin, Madison

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
Metabolic Content of Urine Other: Urine sample Other: Sleep restriction Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 6, 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Change in inflammation [ Time Frame: 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 [ 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05637840


Contacts
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Contact: Laura Van Toll 608-262-9469 laura.vantoll@wisc.edu

Locations
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United States, Wisconsin
University of Wisconsin Recruiting
Madison, Wisconsin, United States, 53705
Contact: Laura Van Toll    608-262-6496    laura.vantoll@wisc.edu   
Principal Investigator: Joshua Coon, MD         
Sponsors and Collaborators
University of Wisconsin, Madison
Morgridge Institute for Research
Investigators
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Principal Investigator: Joshua Coon, MD University of Wisconsin, Madison
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT05637840    
Other Study ID Numbers: 2022-1111
A537700 ( Other Identifier: UW Madison )
SMPH/BIOMOLEC CHEM/BIOMOL CHM ( Other Identifier: UW Madison )
Protocol Version 9/28/22 ( Other Identifier: UW Madison )
First Posted: December 5, 2022    Key Record Dates
Last Update Posted: January 13, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No