Clinical trial NCT05133986: Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake
Official title: Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Metabolomics
Lead sponsor: Manchester Metropolitan University
Sponsor class: OTHER
Collaborators: name: University of Nottingham
First posted: 2021-11-24
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* Healthy
* Non-pregnant/lactating
* BMI between 18.5 and 30 kg/m\^2
* Non-smokers.

Exclusion Criteria:

* Any diagnosed health condition (chronic or infectious diseases)
* Consumption of medications/nutritional supplements
* Any allergies/intolerances to onions/couscous.

Primary outcomes:
measure: Untargeted metabolomics for onion biomarker identification using LC-QTOF-MS.
timeFrame: 24-hours postprandial period following onion or couscous consumption.
measure: Dose-dependency and change in concentration of potential biomarkers identified in Primary Outcome 1
timeFrame: First morning void urine samples following three periods of 4-day onion supplementation.
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: Manchester Metropolitan University
Study officials:
References:
citation: 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.