Study of Metabolic Content of Urine

NCT05637840 | Completed

• 4 other identifiers: 2022-1111A537700SMPH/BIOMOLEC CHEM/BIOMOL CHMProtocol Version 9/28/22
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Metabolic Content of Urine

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Sleep limited

EXPERIMENTAL

Participants will be asked to limit their sleep

Other: Urine sample; Other: Sleep restriction

No sleep limitation

EXPERIMENTAL

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

Other: Urine sample

Interventions

Urine sample OTHER

Collection of 36-84 urine samples over a 14 consecutive day period.

No sleep limitation; Sleep limited

Sleep restriction OTHER

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

Sleep limited

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Morgridge Institute for Research: collaborator

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53705, United States

Location

Study Officials

• Joshua Coon, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2022
• First Posted: December 5, 2022
• Study Start: December 6, 2022
• Primary Completion: November 18, 2023
• Study Completion: November 18, 2023
• Last Updated: February 16, 2024

Record last verified: 2024-02

Locations

US (1)