Study of Metabolic Content of Urine

Study Overview
=================
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.

Official Title
-----------------
Longitudinal Study of Metabolic Content of Human Urine

Conditions
-----------------
Metabolic Content of Urine

Intervention / Treatment
-----------------
* Other: Urine sample
* Other: Sleep restriction


Participation Criteria
=================
Eligibility 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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sleep limited<br>Participants will be asked to limit their sleep | Other: Urine sample<br>* Collection of 36-84 urine samples over a 14 consecutive day period.<br>Other: Sleep restriction<br>* Participants will be asked to limit their sleep to 4 hours within a 24-hour period for 2 days in a row.<br>|
| Experimental: No sleep limitation<br>Participants will be asked to get their normal amount of sleep. | Other: Urine sample<br>* Collection of 36-84 urine samples over a 14 consecutive day period.<br>|

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 |