This trial is active, not recruiting.

Condition nutritional and metabolic diseases
Sponsor Mebo Research, Inc.
Collaborator University of Alberta
Start date February 2016
End date December 2016
Trial size 54 participants
Trial identifier NCT02683876, 201505010014MEBO


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case control
Time perspective prospective
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
individuals not complaining of uncontrollable or unpredictable malodor episodes

Primary Outcomes

Differences in metabolite concentrations measured by mass spectrometry, comparing urine samples from individuals with malodor issues, and age-matched healthy controls.
time frame: ten months

Secondary Outcomes

Correlations between urine biomarkers and frequency/severity of malodor symptoms (questionnaires)
time frame: one year

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

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
Principal investigator David Wishart, PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Mebo Research, Inc..