Exploratory Study of Relationships Between Malodor and Urine Metabolomics

NCT ID: NCT02683876

Last Updated: 2020-10-23

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

39 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-02-29

Study Completion Date

2018-05-31

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.

Conditions

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Nutritional and Metabolic Diseases

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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

No interventions assigned to this group

Healthy control

individuals not complaining of uncontrollable or unpredictable malodor episodes

No interventions assigned to this group

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Alberta

OTHER

Sponsor Role collaborator

Mebo Research, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Wishart, PhD

Role: PRINCIPAL_INVESTIGATOR

The Metabolomics Innovation Centre (TMIC)

Irene Gabashvili, PhD

Role: PRINCIPAL_INVESTIGATOR

MeBo Research

Locations

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MeBO Research

Miami, Florida, United States

Site Status

The Metabolomics Innovation Centre

Edmonton, Alberta, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type BACKGROUND
PMID: 26745651 (View on PubMed)

I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223

Reference Type RESULT

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Related Links

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https://www.metabolomicscentre.ca/

The Metabolomics Innovation Centre (TMIC)

https://aurametrix.com/NCT2683876

Gabashvili, I.S. NCT02683876: Documentation of Clinical Trial Data and Procedures.

Other Identifiers

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201505010014MEBO

Identifier Type: -

Identifier Source: org_study_id

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