Biomarkers of Food Intake Using a Cross-over Feeding Study

Identification of New Dietary Biomarkers Using a Cross-over Feeding Study Among 25 Individuals in University College Dublin

Assessment of dietary intake is key for understanding the links between diet and health. Here, researchers will study molecules in urine samples to give them an insight into what people have eaten. These new molecules are called dietary biomarkers. This study will help to identify new molecules that can act as biomarkers of commonly consumed foods. These can then be used in the assessment of diet, identification of diet-related diseases and used how to explain how a dietary intervention (programme) will work, thereby adding to scientific knowledge.

Study Overview

• Status: Completed
• Conditions: Diet Habit
• Intervention / Treatment: Other: Biomarkers of Fruit and Vegetable Intake

Detailed Description

For biomarker discovery a cross-over study where participants will visit the Human Intervention Centre (in UCD) on 3 occasions (3 study days) with a minimum one week between each visit. The order of consumption of the test foods will be randomized. The test foods are mixed vegetables (spinach and lettuce), green beans and mixed berried (strawberries and blueberries). For each study day, the participants will arrive fasting and provide a urine sample (0h sample). For 24h prior to the study day participants will avoid the test foods. Participants will consume the food and urine samples will be taken at 2, 4, 6 and 24 h post consumption . Standard portions of the test food will be eaten on each occasion. Between the visits, participants will consume their habitual diet.

The samples will be analysed using the metabolomics platforms LC-MS and NMR spectroscopy. Both NMR and LC-MS data generated will undergo statistical analysis such as principal component analysis (PCA) and supervised analysis such as partial least squares-discriminant analysis (PLS-DA). Validation of such models will be performed using permutation testing.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Ireland
  • Dublin 4
    • Dublin, Dublin 4, Ireland, D4
      • University College Dublin

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Healthy adults aged 18-50 years old
2. BMI<30.

Exclusion Criteria:

1. Smokers
2. Diagnosed health condition (chronic or infectious disease)
3. Taking medication (oral contraceptive pill is allowed)
4. Pregnant, lactating
5. Allergies/intolerances to any of specified test foods

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Other: Fruit and Vegetable biomarkers; Each participant will consume the test foods over different weeks

Other: Biomarkers of Fruit and Vegetable Intake; Cross-over study where participants will visit the Human Intervention Centre (in UCD) on 3 occasions (3 study days) with a minimum one week between each visit. The order of consumption of the test foods will be randomized. The test foods are mixed vegetables (spinach and lettuce), green beans and mixed berried (strawberries and blueberries). The following definition of portion sizes will be used; green beans (120g), lettuce (20g), spinach (90g), strawberries (96g) and blueberries (75g). For each study day, the participants will arrive fasting and provide a urine sample (0h sample). For 24h prior to the study day participants will avoid the test foods. Participants will consume the food and urine samples will be taken at 2, 4, 6 and 24 h post consumption.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.	A number of biomarkers will be identified for the test foods. These biomarkers will be measured using LC/MS and NMR spectroscopy and will be reported in relative units. An untargeted approach will be applied to measure the biomarkers, of which hundreds will be measured. These biomarkers will be from different classes of compounds such as amino acids, fatty acids, lipids and carbohydrates for example. Note: A list of biomarkers has not been added as the investigators are using an untargeted metabolomics approach, which will be used to identify biomarkers from different compound classes.	2, 4 and 6 hours post consumption of the test food. Urine samples are taken postprandially to determine how the biomarkers behave post consumption, which is standard practice in dietary biomaker identification studies.

Collaborators and Investigators

• Sponsor: University College Dublin

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2019
• Primary Completion (Actual): December 1, 2020
• Study Completion (Actual): December 20, 2020

Study Registration Dates

• First Submitted: February 19, 2019
• First Submitted That Met QC Criteria: February 25, 2019
• First Posted (Actual): February 26, 2019

Study Record Updates

• Last Update Posted (Actual): May 5, 2021
• Last Update Submitted That Met QC Criteria: May 4, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Keywords: Metabolomics; personalized nutrition; dietary biomarkers
• Other Study ID Numbers: UCD_123_2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No