Using Untargeted Metabolomics to Identify Urinary Biomarkers of Onion Intake

NCT ID: NCT05133986

Last Updated: 2023-05-25

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-06
• Study Completion Date: 2023-12-31

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.

Conditions

Metabolomics

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Onion feeding first, couscous feeding second

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.

Group Type: EXPERIMENTAL

Onion Feeding

Intervention Type: OTHER

The intervention includes feeding individuals a 120g portion of onions (experimental condition).

Couscous Feeding

Intervention Type: OTHER

The intervention includes feeding individuals a 120g portion of couscous (control condition).

Couscous feeding first, onion feeding second

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.

Group Type: EXPERIMENTAL

Onion Feeding

Intervention Type: OTHER

The intervention includes feeding individuals a 120g portion of onions (experimental condition).

Couscous Feeding

Intervention Type: OTHER

The intervention includes feeding individuals a 120g portion of couscous (control condition).

Onion supplementation period

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.

Group Type: OTHER

Onion Supplementation Period

Intervention Type: OTHER

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.

Interventions

Onion Feeding

The intervention includes feeding individuals a 120g portion of onions (experimental condition).

Intervention Type: OTHER

Couscous Feeding

The intervention includes feeding individuals a 120g portion of couscous (control condition).

Intervention Type: OTHER

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.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Nottingham

OTHER

Sponsor Role: collaborator

Manchester Metropolitan University

OTHER

Sponsor Role: lead

Responsible Party

Elliot Owen

PhD Student

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Manchester Metropolitan University

Manchester, , United Kingdom

Countries

United Kingdom

References

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.

Reference Type: BACKGROUND

PMID: 33484153 (View on PubMed)

Other Identifiers

34047

Identifier Type: -

Identifier Source: org_study_id