Skip to main content
Clinical Trials/NCT03855098
NCT03855098
Completed
Not Applicable

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

University College Dublin1 site in 1 country25 target enrollmentSeptember 1, 2019
ConditionsDiet Habit

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Diet Habit
Sponsor
University College Dublin
Enrollment
25
Locations
1
Primary Endpoint
Urinary biomarker changes following consumption of specific foods will be measured using metabolomic approaches in post consumption samples.
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2019
End Date
December 20, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lorraine Brennan

Principle Investigator

University College Dublin

Eligibility Criteria

Inclusion Criteria

  • Healthy adults aged 18-50 years old

Exclusion Criteria

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

Outcomes

Primary Outcomes

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.

Study Sites (1)

Loading locations...

Similar Trials