Study of Metabolic Content of Urine

Not Applicable

Completed

• Conditions: Metabolic Content of Urine
• Interventions: Other: Urine sample; Other: Sleep restriction

• Registration Number: NCT05637840
• Lead Sponsor: 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.

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 Timeline

• Study First Submitted: 2022-11-22
• Study First Submitted QC: 2022-12-02
• Study First Posted: 2022-12-05
• Study Start: 2022-12-06
• Primary Completion: 2023-11-18
• Study Completion: 2023-11-18
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-14
• Last Update Posted: 2024-02-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sleep limited	Sleep restriction	Participants will be asked to limit their sleep
No sleep limitation	Urine sample	Participants will be asked to get their normal amount of sleep.
Sleep limited	Urine sample	Participants will be asked to limit their sleep

Primary Outcome Measures

Name	Time	Method
Change in inflammation	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	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.

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States