Nutritional and Metabolic DiseasesNCT02683876

Exploratory Study of Relationships Between Malodor and Urine Metabolomics

An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Nutritional and Metabolic Diseases
How many people: 39 participants
Where: 2 sitesin 2 countries
Study dates: Feb 2016to May 2018
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

MeBO Research
Miami, Florida, 33175

Other trials in United States

Canada1 site

The Metabolomics Innovation Centre
Edmonton, Alberta, T6G 2E9

Other trials in Canada

About this study

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

Read the 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.

Conditions: Nutritional and Metabolic Diseases
Keywords: body odor, malodor, halitosis
Medical subject headings: Nutritional and Metabolic Diseases, Body Odor, Halitosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02683876
Study group	Role	What they receive
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 being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: time from diagnostic urine sample collection to dispatch of results

Secondary outcomes (1)

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.
Measured: time from sample collection to notification of results and follow-up needed.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016May 2018

First posted17 Feb 2016 (estimated)
Study startFeb 2016
Primary completion30 Aug 2017
Study completionMay 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Nutritional and Metabolic DiseasesStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case-control
Time perspective: Prospective
Enrolment: 39 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02683876
Sponsor's protocol ID: 201505010014MEBO
Status last verified: Oct 2020
First submitted: 3 Feb 2016
Last updated: 23 Oct 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
Individual data sharing: No: to prevent risks of re-identification.

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.
PubMed 26745651
I.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Nutritional and Metabolic Diseases trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02683876
Acronym / sponsor ID: 201505010014MEBO
Conditions: Nutritional and Metabolic Diseases
Keywords: body odor, malodor, halitosis
Study type: Observational
Recruitment status: Completed
Enrolment: 39 participants (actual)
Lead sponsor: Mebo Research, Inc.University, hospital or other
Collaborators: University of Alberta
Study start: Feb 2016 (actual)
Primary completion: 30 Aug 2017 (actual)
Study completion: May 2018 (actual)
First posted: 17 Feb 2016 (estimated)
Results: Posted 23 Oct 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Observational model: Case-control
Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
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

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism

Key inclusion criteria (4 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Primary outcome

Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.
Time frame: time from diagnostic urine sample collection to dispatch of results
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.

1 secondary outcome

Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires)
Time frame: time from sample collection to notification of results and follow-up needed.

Results and safety

Results posted to the registry on 23 Oct 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Subjects With Malodor	17	15
Healthy Control	22	22

Primary outcome: Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls.

Time frame: time from diagnostic urine sample collection to dispatch of results. Mean (Full Range). Unit: uMol/mM creatinine

Measure	Subjects With Malodor n = 15	Healthy Control n = 22
Arginine	3.4 (1.3 to 7.9)	8.6 (1.5 to 18.6)
Citruline	0.443 (0.175 to 1.185)	0.8 (0.2 to 1.7)
Asymmetric dimethylarginine	4.0 (2.8 to 7.0)	3.0 (0.2 to 7.0)
Dopamine	0.18 (0.10 to 0.28)	0.10 (0.066 to 0.30)
Glycine	142.5 (45.4 to 283.0)	101.0 (37.0 to 300.0)
Histamine	0.05 (0.016 to 0.15)	0.03 (0.01 to 0.10)
3-Hydroxytetradecenoylcarnitine	0.0080 (0.001 to 0.087)	0.0020 (0.0008 to 0.0040)
Lysine	4.7 (2.3 to 10.3)	17.9 (3.6 to 56.1)

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected for 6 months after sample collection, 1 year after initial enrollment.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Subjects With Malodor	0 of 17 (0%)	0 of 17 (0%)	0 of 17
Healthy Control	0 of 22 (0%)	0 of 22 (0%)	0 of 22

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 26745651Emwas 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.
Results publicationI.S. Gabashvili. Identifying subtypes of a stigmatized medical condition medRxiv 19005223; doi: https://doi.org/10.1101/19005223
The Metabolomics Innovation Centre (TMIC)Link provided by the sponsor.
MeBO ResearchLink provided by the sponsor.
Gabashvili, I.S. NCT02683876: Documentation of Clinical Trial Data and Procedures.Link provided by the sponsor.
Individual participant dataSharing planned: No. to prevent risks of re-identification.

Related trials for Nutritional and Metabolic Diseases

Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
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Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

David Wishart, PhD principal investigator

The Metabolomics Innovation Centre (TMIC)

Irene Gabashvili, PhD principal investigator

MeBo Research

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Nutritional and Metabolic Diseases, run by Mebo Research, Inc. at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Oct 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. (time frame: time from diagnostic urine sample collection to dispatch of results). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02683876, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.