MetabolomicsNCT05133986
Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake
A study testing Onion Feeding, Couscous Feeding and Onion Supplementation Period in people with Metabolomics, run by Manchester Metropolitan University at 1 site in United Kingdom.
Trial summary
Fruit and vegetable (FV) intake has been reported as a modifiable risk factor of globally pervasive chronic diseases. Traditionally, the measurement of dietary intake has been conducted via self-report methods such as food diaries, food frequency questionnaires, and dietary recall. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Metabolomics
- What is being tested?
- Onion Feeding, Couscous Feeding and Onion Supplementation Period
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Apr 2022to 31 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
Who may be able to join
- Healthy
- Non-pregnant/lactating
- BMI between 18.5 and 30 kg/m^2
- Non-smokers.
Who cannot join
- Any diagnosed health condition (chronic or infectious diseases)
- Consumption of medications/nutritional supplements
- Any allergies/intolerances to onions/couscous.
Trial locations and contacts
1 site in 1 country.
About this study
Fruit and vegetable (FV) intake has been reported as a modifiable risk factor of globally pervasive chronic diseases. Traditionally, the measurement of dietary intake has been conducted via self-report methods such as food diaries, food frequency questionnaires, and dietary recall. These methods are inherently subject to sources of error and biases. The objective measurement of diet-specific urinary biomarkers has been proposed as an alternate assessment method. A dose-dependent biomarker or biomarker panel for total FV intake has been investigated but not successfully established. In a recent publication as part of this PhD research, the researchers outlined a concise panel of 7 FVs that are predictive of total FV intake in a UK population. Recent studies have implemented an untargeted metabolomic approach to identify novel biomarkers of some of the 7 FVs identified in our prior research, but not with onion intake. The aim of this study is to detect, quantify and identify dose-dependent biomarker(s) of onion intake in a UK population using untargeted metabolomics. Phase 1 will be an acute randomised crossover intervention study, involving the consumption of a standardised portion of cooked onions (test) or couscous (control). Urine samples over the 24-hour period post-consumption will be collected. Phase 2 will be a dose-dependent crossover intervention study, where participants are supplied with supplementary onion portions (low, medium, high) to be consumed with their habitual evening meals. Within each supplementation period, participants will consume the same quantity of onions across the 4 days and collect a midstream first void urine samples on the fifth day. Trial order will be randomised, and a washout period of 3 days will be implemented between supplementation periods. 14 participants will be recruited for both phases of data collection. Urine samples will be analysed by high-performance liquid-chromatography with quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) to identify potential biomarkers.
- Conditions
- Metabolomics
- Being tested
- Onion Feeding, Couscous Feeding, Onion Supplementation Period
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Onion FeedingOther
The intervention includes feeding individuals a 120g portion of onions (experimental condition).
Couscous FeedingOther
The intervention includes feeding individuals a 120g portion of couscous (control condition).
Onion Supplementation PeriodOther
Three 4-day supplementation periods separated by two 3-day washout periods. Supplementation periods will provide participants with a daily portion of onions to be consumed with their evening meals. The daily quantity of onion supplementation, low (40g), medium, (80g) and high (160g), will remain constant throughout each 4-day period, and the order will be individually randomised.
| Study group | Role | What they receive |
|---|---|---|
| Onion feeding first, couscous feeding second | Experimental | Participants will report to the laboratory at 8am in a fasted state (water consumption is permitted) and provide a spot baseline urine sample. Participants will then be served a 120g portion of onions (experimental condition), prepared under standardized conditions. Participants shall remain supervised in the laboratory and will only consume water (100mL per hour) for the subsequent 6 hours, after which participants are free to consume their habitual diet (except alcohol, tea coffee, and FVs). In the 24-hour postprandial test period, participants will obtain urine samples at several time-points. Urine collection vessels will be used to obtain samples at 0-1, 1-2, 2-4, 4-6, 6-12, 12-24 hours. This experimental protocol shall be repeated following a 4-day washout period (habitual diet consumption with no restrictions imposed on participants) with 120g of couscous consumed instead of onions, as a control condition. Receives: Other: Onion Feeding; Other: Couscous Feeding |
| Couscous feeding first, onion feeding second | Experimental | Participants will report to the laboratory at 8am in a fasted state (water consumption is permitted) and provide a spot baseline urine sample. Participants will then be served a 120g portion of couscous (control condition), prepared under standardized conditions. Participants shall remain supervised in the laboratory and will only consume water (100mL per hour) for the subsequent 6 hours, after which participants are free to consume their habitual diet (except alcohol, tea coffee, and FVs). In the 24-hour postprandial test period, participants will obtain urine samples at several time-points. Urine collection vessels will be used to obtain samples at 0-1, 1-2, 2-4, 4-6, 6-12, 12-24 hours. This experimental protocol shall be repeated following a 4-day washout period (habitual diet consumption with no restrictions imposed on participants) with 120g of onions consumed instead of couscous, as an experimental condition. Receives: Other: Onion Feeding; Other: Couscous Feeding |
| Onion supplementation period | Other | This dose-dependent biomarker validation intervention will include three 4-day supplementation periods separated by two 3-day washout periods. Supplementation periods will provide participants with a daily portion of onions to be consumed with their evening meals. The daily quantity of onion supplementation, low (40g), medium, (80g) and high (160g), will remain constant throughout each 4-day period, and the order will be individually randomised. Participants will be asked to avoid onion intake throughout the supplementation periods, other than the portions provided by researchers. First morning void urine samples will be collected by participants on the morning after the supplementation period and obtained by researchers. Receives: Other: Onion Supplementation Period |
What is being measured
The primary outcome is the main question the study is designed to answer.
Untargeted metabolomics for onion biomarker identification using LC-QTOF-MS.
Urine samples will be analysed to putatively identify biomarkers of onion intake by comparison with control samples using high-performance liquid chromatography coupled to a quadrupole time-of-flight mass spectrometer (LC-QTOF-MS). LC-QTOF-MS analysis allows the simultaneous high-resolution measurement of a broad range of metabolites, hence the untargeted nature of the analysis. Multivariate statistical analysis and Partial least squares Discriminant Analysis included in the mass spectrometry software will be used to analyse LC-QTOF-MS results to identify features that best discriminate between test and control conditions.
Measured: 24-hours postprandial period following onion or couscous consumption.
Dose-dependency and change in concentration of potential biomarkers identified in Primary Outcome 1
First morning void urine samples will be obtained after three separate 4-day periods of supplementing evening meals with 40g, 80g and 160g of onions. The validity of candidate biomarkers from the first phase of the study, Primary Outcome 1, shall be assessed by LC-QTOF-MS - quantifying urinary concentrations following the consumption of multiple doses of onions across a range of servings.
Measured: First morning void urine samples following three periods of 4-day onion supplementation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2021
- Study start6 Apr 2022
- Primary completion1 Dec 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MetabolomicsStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester Metropolitan University
- Sponsor type
- University, hospital or other
- Collaborators
- University of Nottingham
- Responsible party
- Principal investigator, Elliot Owen, Manchester Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05133986
- Sponsor's protocol ID
- 34047
- Status last verified
- May 2023
- First submitted
- 2 Nov 2021
- Last updated
- 25 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owen EJ, Patel S, Flannery O, Dew TP, O'Connor LM. Derivation and Validation of a Total Fruit and Vegetable Intake Prediction Model to Identify Targets for Biomarker Discovery Using the UK National Diet and Nutrition Survey. J Nutr. 2021 Apr 8;151(4):962-969. doi: 10.1093/jn/nxaa406.
PubMed 33484153
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake
- ClinicalTrials.gov ID
- NCT05133986
- Acronym / sponsor ID
- 34047
- Conditions
- Metabolomics
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Manchester Metropolitan UniversityUniversity, hospital or other
- Collaborators
- University of Nottingham
- Study start
- 6 Apr 2022 (actual)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 24 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Fruit and vegetable (FV) intake has been reported as a modifiable risk factor of globally pervasive chronic diseases. Traditionally, the measurement of dietary intake has been conducted via self-report methods such as food diaries, food frequency questionnaires, and dietary recall. These methods are inherently subject to sources of error and biases. The objective measurement of diet-specific urinary biomarkers has been proposed as an alternate assessment method. A dose-dependent biomarker or biomarker panel for total FV intake has been investigated but not successfully established. In a recent publication as part of this PhD research, the researchers outlined a concise panel of 7 FVs that are predictive of total FV intake in a UK population. Recent studies have implemented an untargeted metabolomic approach to identify novel biomarkers of some of the 7 FVs identified in our prior research, but not with onion intake. The aim of this study is to detect, quantify and identify dose-dependent biomarker(s) of onion intake in a UK population using untargeted metabolomics. Phase 1 will be an acute randomised crossover intervention study, involving the consumption of a standardised portion of cooked onions (test) or couscous (control). Urine samples over the 24-hour period post-consumption will be collected. Phase 2 will be a dose-dependent crossover intervention study, where participants are supplied with supplementary onion portions (low, medium, high) to be consumed with their habitual evening meals. Within each supplementation period, participants will consume the same quantity of onions across the 4 days and collect a midstream first void urine samples on the fifth day. Trial order will be randomised, and a washout period of 3 days will be implemented between supplementation periods. 14 participants will be recruited for both phases of data collection. Urine samples will be analysed by high-performance liquid-chromatography with quadrupole time-of-flight mass spectrometry (LC-QTOF-MS) to identify potential biomarkers.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Onion feeding first, couscous feeding second | Experimental | Other: Onion Feeding, Other: Couscous FeedingParticipants will report to the laboratory at 8am in a fasted state (water consumption is permitted) and provide a spot baseline urine sample. Participants will then be served a 120g portion of onions (experimental condition), prepared under standardized conditions. Participants shall remain supervised in the laboratory and will only consume water (100mL per hour) for the subsequent 6 hours, after which participants are free to consume their habitual diet (except alcohol, tea coffee, and FVs). In the 24-hour postprandial test period, participants will obtain urine samples at several time-points. Urine collection vessels will be used to obtain samples at 0-1, 1-2, 2-4, 4-6, 6-12, 12-24 hours. This experimental protocol shall be repeated following a 4-day washout period (habitual diet consumption with no restrictions imposed on participants) with 120g of couscous consumed instead of onions, as a control condition. |
| Couscous feeding first, onion feeding second | Experimental | Other: Onion Feeding, Other: Couscous FeedingParticipants will report to the laboratory at 8am in a fasted state (water consumption is permitted) and provide a spot baseline urine sample. Participants will then be served a 120g portion of couscous (control condition), prepared under standardized conditions. Participants shall remain supervised in the laboratory and will only consume water (100mL per hour) for the subsequent 6 hours, after which participants are free to consume their habitual diet (except alcohol, tea coffee, and FVs). In the 24-hour postprandial test period, participants will obtain urine samples at several time-points. Urine collection vessels will be used to obtain samples at 0-1, 1-2, 2-4, 4-6, 6-12, 12-24 hours. This experimental protocol shall be repeated following a 4-day washout period (habitual diet consumption with no restrictions imposed on participants) with 120g of onions consumed instead of couscous, as an experimental condition. |
| Onion supplementation period | Other | Other: Onion Supplementation PeriodThis dose-dependent biomarker validation intervention will include three 4-day supplementation periods separated by two 3-day washout periods. Supplementation periods will provide participants with a daily portion of onions to be consumed with their evening meals. The daily quantity of onion supplementation, low (40g), medium, (80g) and high (160g), will remain constant throughout each 4-day period, and the order will be individually randomised. Participants will be asked to avoid onion intake throughout the supplementation periods, other than the portions provided by researchers. First morning void urine samples will be collected by participants on the morning after the supplementation period and obtained by researchers. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Healthy
- Non-pregnant/lactating
- BMI between 18.5 and 30 kg/m^2
- Non-smokers.
Key exclusion criteria (3 listed)
- Any diagnosed health condition (chronic or infectious diseases)
- Consumption of medications/nutritional supplements
- Any allergies/intolerances to onions/couscous.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Onion FeedingThe intervention includes feeding individuals a 120g portion of onions (experimental condition). | Other | Couscous feeding first, onion feeding second, Onion feeding first, couscous feeding second |
| Couscous FeedingThe intervention includes feeding individuals a 120g portion of couscous (control condition). | Other | Couscous feeding first, onion feeding second, Onion feeding first, couscous feeding second |
| Onion Supplementation PeriodThree 4-day supplementation periods separated by two 3-day washout periods. Supplementation periods will provide participants with a daily portion of onions to be consumed with their evening meals. The daily quantity of onion supplementation, low (40g), medium, (80g) and high (160g), will remain constant throughout each 4-day period, and the order will be individually randomised. | Other | Onion supplementation period |
Primary outcome
Untargeted metabolomics for onion biomarker identification using LC-QTOF-MS.
Time frame: 24-hours postprandial period following onion or couscous consumption.
Urine samples will be analysed to putatively identify biomarkers of onion intake by comparison with control samples using high-performance liquid chromatography coupled to a quadrupole time-of-flight mass spectrometer (LC-QTOF-MS). LC-QTOF-MS analysis allows the simultaneous high-resolution measurement of a broad range of metabolites, hence the untargeted nature of the analysis. Multivariate statistical analysis and Partial least squares Discriminant Analysis included in the mass spectrometry software will be used to analyse LC-QTOF-MS results to identify features that best discriminate between test and control conditions.
Dose-dependency and change in concentration of potential biomarkers identified in Primary Outcome 1
Time frame: First morning void urine samples following three periods of 4-day onion supplementation.
First morning void urine samples will be obtained after three separate 4-day periods of supplementing evening meals with 40g, 80g and 160g of onions. The validity of candidate biomarkers from the first phase of the study, Primary Outcome 1, shall be assessed by LC-QTOF-MS - quantifying urinary concentrations following the consumption of multiple doses of onions across a range of servings.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2023.
- Background: PubMed 33484153Owen EJ, Patel S, Flannery O, Dew TP, O'Connor LM. Derivation and Validation of a Total Fruit and Vegetable Intake Prediction Model to Identify Targets for Biomarker Discovery Using the UK National Diet and Nutrition Survey. J Nutr. 2021 Apr 8;151(4):962-969. doi: 10.1093/jn/nxaa406.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Onion Feeding, Couscous Feeding and Onion Supplementation Period in people with Metabolomics, run by Manchester Metropolitan University at 1 site in United Kingdom.
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 3 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: status not confirmed, as of the sponsor's last update on 25 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. 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?
Results are not available in the source record.
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?
Untargeted metabolomics for onion biomarker identification using LC-QTOF-MS. (time frame: 24-hours postprandial period following onion or couscous consumption.). The study lists 2 primary outcomes in all. 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 NCT05133986, which also lists 1 linked publication.
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 25 May 2023.