Nutritional and Metabolic Diseases
Conditions
Keywords
body odor, malodor, halitosis
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.
Interventions
None listed
Sponsors
University of Alberta
Mebo Research, Inc.
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | time from sample collection to notification of results and follow-up needed. | 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. |
Countries
Canada, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subjects With Malodor individuals with self-reported socially debilitating odor episodes | 17 |
| Healthy Control individuals not complaining of uncontrollable or unpredictable malodor episodes | 22 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | samples damaged during shipping | 2 | 0 |
Baseline characteristics
| Characteristic | Subjects With Malodor | Healthy Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 1 Participants | 1 Participants |
| Age, Categorical Between 18 and 65 years | 17 Participants | 21 Participants | 38 Participants |
| Metabolites measured in urine samples | 15 Participants | 22 Participants | 37 Participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 17 participants | 22 participants | 39 participants |
| Sex: Female, Male Female | 12 Participants | 8 Participants | 20 Participants |
| Sex: Female, Male Male | 5 Participants | 14 Participants | 19 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 22 |
| other Total, other adverse events | 0 / 17 | 0 / 22 |
| serious Total, serious adverse events | 0 / 17 | 0 / 22 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Arginine | 3.4 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Citruline | 0.443 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Asymmetric dimethylarginine | 4.0 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Dopamine | 0.18 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Glycine | 142.5 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Histamine | 0.05 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | 3-Hydroxytetradecenoylcarnitine | 0.0080 uMol/mM creatinine |
| Subjects With Malodor | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Lysine | 4.7 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Lysine | 17.9 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Arginine | 8.6 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Glycine | 101.0 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Citruline | 0.8 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | 3-Hydroxytetradecenoylcarnitine | 0.0020 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Asymmetric dimethylarginine | 3.0 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Histamine | 0.03 uMol/mM creatinine |
| Healthy Control | Differences in Metabolite Concentrations in Urine Between Individuals With Malodor Issues and Age-matched Healthy Controls. | Dopamine | 0.10 uMol/mM creatinine |
Secondary
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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Arginine | 3 µmol/mmol creatinine | Standard Deviation 2 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Citruline | 0.5 µmol/mmol creatinine | Standard Deviation 0.3 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Asymmetric dimethylarginine | 4 µmol/mmol creatinine | Standard Deviation 2 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Dopamine | 0.2 µmol/mmol creatinine | Standard Deviation 0.1 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Glycine | 146 µmol/mmol creatinine | Standard Deviation 91 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Histamine | 0.06 µmol/mmol creatinine | Standard Deviation 0.04 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | 3-Hydroxytetradecenoylcarnitine | 0.012 µmol/mmol creatinine | Standard Deviation 0.028 |
| Subjects With Malodor | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Lysine | 5 µmol/mmol creatinine | Standard Deviation 3 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Lysine | 4 µmol/mmol creatinine | Standard Deviation 3 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Arginine | 3 µmol/mmol creatinine | Standard Deviation 2 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Glycine | 121 µmol/mmol creatinine | Standard Deviation 90 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Citruline | 0.4 µmol/mmol creatinine | Standard Deviation 0.3 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | 3-Hydroxytetradecenoylcarnitine | 0.002 µmol/mmol creatinine | Standard Deviation 0.001 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Asymmetric dimethylarginine | 3 µmol/mmol creatinine | Standard Deviation 1 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Histamine | 0.04 µmol/mmol creatinine | Standard Deviation 0.03 |
| Healthy Control | Correlations Between Urine Biomarkers and Frequency/Severity of Malodor Symptoms (Questionnaires) | Dopamine | 0.2 µmol/mmol creatinine | Standard Deviation 0.1 |