Study of Metabolic Content of Urine

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.

Study Overview

• Status: Completed
• Conditions: Metabolic Content of Urine
• Intervention / Treatment: Other: Urine sample; Other: Sleep restriction

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 Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laura Van Toll; Phone Number: 608-262-9469; Email: laura.vantoll@wisc.edu

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53705
      • University of Wisconsin
      • Contact: Laura Van Toll; Phone Number: 608-262-6496; Email: laura.vantoll@wisc.edu
      • Principal Investigator: Joshua Coon, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in inflammation	Changes in inflammation will be measured by hs-CRP via short-term sleep restriction.	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.	Daily for 14 days

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: Morgridge Institute for Research
• Investigators: Principal Investigator: Joshua Coon, PhD, University of Wisconsin, Madison

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2022
• Primary Completion (Actual): November 18, 2023
• Study Completion (Actual): November 18, 2023

Study Registration Dates

• First Submitted: November 22, 2022
• First Submitted That Met QC Criteria: December 2, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): February 16, 2024
• Last Update Submitted That Met QC Criteria: February 14, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• 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)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No