Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake

Metabolomics Clinical Trial

Official title:

Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05133986
• Other study ID #: 34047
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: December 31, 2023

Study information

• Verified date: May 2023
• Source: Manchester Metropolitan University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 16
• Est. completion date: December 31, 2023
• Est. primary completion date: December 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Metabolomics

Intervention

Other:
• Onion Feeding
The intervention includes feeding individuals a 120g portion of onions (experimental condition).
• Couscous Feeding
The intervention includes feeding individuals a 120g portion of couscous (control condition).
• Onion Supplementation Period
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.

Locations

Country	Name	City	State
United Kingdom	Manchester Metropolitan University	Manchester

Sponsors (2)

Lead Sponsor	Collaborator
Manchester Metropolitan University	University of Nottingham

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	24-hours postprandial period following onion or couscous consumption.
Primary	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.	First morning void urine samples following three periods of 4-day onion supplementation.