Clinical trial NCT02683876: Exploratory Study of Relationships Between Malodor and Urine Metabolomics
Official title: Metabolomic Profiling of Urine Samples for the Identification of Novel Biomarkers and Mechanisms in the Diagnosis and Management of Malodor Associated With Metabolic Inefficiencies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Nutritional and Metabolic Diseases
Keywords: body odor, malodor, halitosis
Lead sponsor: Mebo Research, Inc.
Sponsor class: OTHER
Collaborators: name: University of Alberta
First posted: 2016-02-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
timeFrame: time from diagnostic urine sample collection to dispatch of results
Secondary outcomes:
measure: Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
timeFrame: time from sample collection to notification of results and follow-up needed.
Other outcomes:
Locations:
city: Miami
country: United States
facility: MeBO Research
state: Florida
city: Edmonton
country: Canada
facility: The Metabolomics Innovation Centre
state: Alberta
Study officials:
affiliation: The Metabolomics Innovation Centre (TMIC)
name: David Wishart, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: MeBo Research
name: Irene Gabashvili, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223