Exploratory Study of Relationships Between Malodor and Urine Metabolomics

Study Overview
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Brief Summary
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The purpose of this study is to identify metabolic signatures associated with malodor conditions. The investigators will perform state-of-the art metabolomics tests and bioinformatic data mining to explore if conditions leading to malodor can be screened by metabolomic profiling of urine samples.

Detailed Description
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In this study, metabolite profiling analysis will be carried out on urine samples of individuals with malodor conditions related to metabolism inefficiencies. Metabolic profiles will be identified using the metabolomics equipment located in the NMR, HPLC and MS facilities of the Metabolomics Innovation Centre (TMIC). Multivariate statistical analyses will be used, as well as other approaches to mine complex data from heterogeneous sources.

Official Title
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Metabolomic Profiling of Urine Samples for the Identification of Novel Biomarkers and Mechanisms in the Diagnosis and Management of Malodor Associated With Metabolic Inefficiencies

Conditions
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Nutritional and Metabolic Diseases

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years or older unpredictable and uncontrollable episodes of malodor willing and able to ship a urine sample (in the kit provided) by an overnight courier to Edmonton, Alberta, Canada good general health Exclusion Criteria: serious medical conditions that require treatment conditions that, in the opinion of the investigator, would prevent participation under the age of 18 elect not to participate in the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with malodor<br>individuals with self-reported odor issues suspected to be associated with microbial imbalance on or inside the body and inefficient metabolism as evidenced from other laboratory tests | |
| Healthy control<br>individuals not complaining of uncontrollable or unpredictable malodor episodes | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | The investigators would like to validate if urine metabolomic profiling can be used for identifying key metabolomic signatures associated with malodor. Differences in metabolite concentrations will be measured by mass spectrometry, to compare urine samples from individuals with malodor issues, and age-matched healthy controls. | time from diagnostic urine sample collection to dispatch of results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | The investigators will comprehensively analyze the ability of metabolite levels to discriminate frequent and severe from less severe malodor symptoms. The severity of the disease was assessed trough interviews (frequency of key symptoms) and prior laboratory tests. | time from sample collection to notification of results and follow-up needed. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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body odor, malodor, halitosis