An observational study in Nutritional and Metabolic Diseases, sponsored by Mebo Research, Inc.. Completed at 2 sites in 2 countries. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by Mebo Research, Inc. · Observational
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.
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.
individuals complaining of uncontrollable episodes of malodor suspected to be caused by inefficient body metabolism
Exclusion Criteria:
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
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 frame: time from diagnostic urine sample collection to dispatch of results
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 frame: time from sample collection to notification of results and follow-up needed.
| Milestone | Subjects With Malodor | Healthy Control |
|---|---|---|
| Started | 17 | 22 |
| Completed | 15 | 22 |
| Not completed | 2 | 0 |
| Withdrew: Samples damaged during shipping | 2 | 0 |
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.
| uMol/mM creatinine | Subjects With Malodor | Healthy Control |
|---|---|---|
| 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) |
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.
| µmol/mmol creatinine | Subjects With More Severe Disease | Subjects With Less Severe Disease |
|---|---|---|
| Arginine | 3 ± 2 | 3 ± 2 |
| Citruline | 0.5 ± 0.3 | 0.4 ± 0.3 |
| Asymmetric dimethylarginine | 4 ± 2 | 3 ± 1 |
| Dopamine | 0.2 ± 0.1 | 0.2 ± 0.1 |
| Glycine | 146 ± 91 | 121 ± 90 |
| Histamine | 0.06 ± 0.04 | 0.04 ± 0.03 |
| 3-Hydroxytetradecenoylcarnitine | 0.012 ± 0.028 | 0.002 ± 0.001 |
| Lysine | 5 ± 3 | 4 ± 3 |
Collected over Adverse event data was collected for 6 months after sample collection, 1 year after initial enrollment.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Subjects With Malodor | 0/17 (0%) | 0/17 (0%) | 0/17 (0%) |
| Healthy Control | 0/22 (0%) | 0/22 (0%) | 0/22 (0%) |
| Age, Categorical(Participants) | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 17 | 21 | 38 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| Female | 12 | 8 | 20 |
| Male | 5 | 14 | 19 |
| Race and Ethnicity Not Collected(Participants) | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| Canada | 17 | 22 | 39 |
| Metabolites measured in urine samples(Participants) | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| Count of participants | 15 | 22 | 37 |
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Mebo Research, Inc.