Exploratory Study of Relationships Between Malodor and Urine Metabolomics

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

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.

Study Overview

• Status: Completed
• Conditions: Nutritional and Metabolic Diseases

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 39

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada, T6G 2E9
      • The Metabolomics Innovation Centre
• United States
  • Florida
    • Miami, Florida, United States, 33175
      • MeBO Research

Participation Criteria

Eligibility Criteria

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

• Sampling Method: Non-Probability Sample

Study Population

individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Subjects with malodor; 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; individuals not complaining of uncontrollable or unpredictable malodor episodes

What is the study measuring?

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.

Collaborators and Investigators

• Sponsor: Mebo Research, Inc.
• Collaborators: University of Alberta
• Investigators: Principal Investigator: David Wishart, PhD, The Metabolomics Innovation Centre (TMIC)

Publications and helpful links

General Publications

• Emwas AH, Roy R, McKay RT, Ryan D, Brennan L, Tenori L, Luchinat C, Gao X, Zeri AC, Gowda GA, Raftery D, Steinbeck C, Salek RM, Wishart DS. Recommendations and Standardization of Biomarker Quantification Using NMR-Based Metabolomics with Particular Focus on Urinary Analysis. J Proteome Res. 2016 Feb 5;15(2):360-73. doi: 10.1021/acs.jproteome.5b00885. Epub 2016 Jan 20.
• I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223

Helpful Links

• The Metabolomics Innovation Centre (TMIC)
• MeBO Research
• Gabashvili, I.S. NCT02683876: Documentation of Clinical Trial Data and Procedures.

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): August 30, 2017
• Study Completion (Actual): May 1, 2018

Study Registration Dates

• First Submitted: February 3, 2016
• First Submitted That Met QC Criteria: February 11, 2016
• First Posted (Estimate): February 17, 2016

Study Record Updates

• Last Update Posted (Actual): October 23, 2020
• Last Update Submitted That Met QC Criteria: October 22, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: body odor, malodor, halitosis
• Additional Relevant MeSH Terms: Metabolic Diseases
• Other Study ID Numbers: 201505010014MEBO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: to prevent risks of re-identification.