Skip to main content
OpenTrials
Completed

NCT Number: NCT03855098

Biomarkers of Food Intake Using a Cross-over Feeding Study

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University College Dublin

Dublin, Dublin 4, D4, Ireland

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Biomarkers of Fruit and Vegetable Intake

Other

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.

Primary outcomes

  1. Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.

    Time frame: 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.

    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.

Sponsors and collaborators

Lead sponsor

University College Dublin

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Feb 26, 2019
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.